Unsettled Baby Algorithm

Step 1

Safety — Red Flags & Emergency Exclusion

Safety

Done

Scope: Infants aged 0–6 months presenting with excessive crying, unsettled behaviour or feeding-related distress. This guide supports primary-care assessment; it does not replace local paediatric, surgical, safeguarding or sepsis pathways. NICE has no dedicated unsettled baby/colic algorithm — recommendations here combine NICE recommendations, evidence-informed clinical suggestions, local pathway/expert consensus and product-specific prescribing information, labelled by source.

First question — is the infant ill? Assess appearance and responsiveness; colour, breathing and circulation; temperature; feeding and urine output; vomiting, stool and abdominal symptoms; neurological symptoms; injury or safeguarding concerns. A sick infant can present as inconsolable crying.

⚠️ Suspected physical abuse / abusive head trauma — always consider Inconsolable crying is a recognised trigger for abusive head trauma. A sensitive, non-judgemental question ("Has anyone shaken or dropped the baby?") may be appropriate, but must not replace a full safeguarding assessment — wider history, developmental capability, injury pattern and information from other agencies (NICE CG89 Child maltreatment). Concerning features: unexplained bruising in a non-mobile infant, long bone fractures, inconsistent history. Retinal haemorrhages are concerning but not pathognomonic; primary-care ophthalmoscopy is not a definitive test — formal retinal examination is arranged by the specialist team. If any concern → Same-day paediatric assessment (immediate if abusive head trauma suspected) + safeguarding referral via practice safeguarding lead/Named GP and local children's safeguarding pathway; 999 if the infant is unstable. Document fully.

Any of: weak, high-pitched or continuous cry; reduced responsiveness; bulging fontanelle; non-blanching rash; focal neurological signs or seizures; mottled, pale, blue or ashen appearance; grunting or respiratory distress Possible meningitis / sepsis (NICE NG143 traffic light) — the full combination is not needed; a normal fontanelle or absent neck stiffness does not exclude meningitis → 999 immediately

Bilious (green) vomiting, marked abdominal distension, peritonism, collapse or failure to pass stool Possible surgical emergency (specific causes such as volvulus are not established in primary care) → 999 — immediate emergency paediatric/surgical assessment — do not delay transfer for primary-care investigations

Paroxysmal screaming episodes + drawing up legs + blood in stool ("redcurrant jelly") Intussusception (most common 6–12 months) → 999 / immediate emergency paediatric/surgical assessment

Sudden pallor + collapse + inconsolable cry + rigid abdomen Possible surgical emergency or shock → 999

Measured temperature ≥38°C in infant <3 months High risk for serious illness (NICE NG143) — do not manage as uncomplicated colic. Record temperature, heart rate and respiratory rate; investigations follow the paediatric fever/sepsis pathway. Fever after recent vaccination still needs clinical risk assessment. → Urgent hospital/paediatric assessment (NICE NG143)

Inconsolable cry + swollen painful limb + reduced movement of arm / leg Fracture (consider physical abuse), septic arthritis, osteomyelitis → Same-day ED + safeguarding

Tense, irreducible groin swelling + crying + vomiting Possible incarcerated inguinal hernia (more common in premature males) → Immediate emergency paediatric/surgical assessment (999 only if collapsed)

Sudden change in cry quality + neurological signs + episodes of eye deviation / twitching Seizures, raised intracranial pressure, intracranial haemorrhage (consider abusive head trauma) → 999

Excessive infant crying commonly peaks at 4–8 weeks and improves by 3–4 months — but this natural history makes it a dangerous diagnosis by reassurance. The most feared diagnosis in an unsettled baby is suspected physical abuse, particularly abusive head trauma — crying is a recognised trigger. Every consultation for an unsettled baby should include a brief, non-judgemental assessment of parental distress and coping — directly asking "Sometimes babies' crying can make parents feel like they might lose control — have you felt this way?" opens a crucial conversation. Meningitis in infants may not present with neck stiffness — a bulging fontanelle, high-pitched cry, and non-specific deterioration are sufficient to warrant urgent assessment. Intussusception classically presents at 6–12 months with episodic screaming, pallor, and red-currant jelly stool — it is a surgical emergency requiring air-enema reduction.

Step 2

Diagnose — Characterise the Crying Pattern

Diagnose

Done

The pattern of crying, the baby's behaviour between episodes, and the parent's description are the primary diagnostic tools. Document: age, gestation and onset; crying pattern and duration; behaviour between episodes; feeding method, volumes, preparation and frequency; vomiting/regurgitation (colour, force, timing); stools (blood, mucus, diarrhoea, constipation); fever and infectious symptoms; rash/eczema; weight trajectory; parental coping, mental health and safeguarding risks.

Definition of infantile colic

Clinical diagnosis in an otherwise well infant after assessment has not identified an organic cause (Rome IV: recurrent, prolonged, unexplained, difficult-to-soothe crying in an infant under 5 months, with no fever, illness or faltering growth). The traditional Wessel "rule of three" (crying >3 hours/day, >3 days/week, for at least 3 weeks) is context only, not a rigid diagnostic threshold. Infantile colic — present in 10–30% of infants. Crying commonly peaks at 4–8 weeks and improves by 3–4 months.

Time of day pattern

Evening clustering: physiological unsettledness (normal growth period, cluster feeding in breastfed infants). Unpredictable / anytime: organic cause more likely. Postprandial: reflux, overfeeding, lactose overload.

Behaviour between episodes

Well between episodes → infantile colic most likely. Unwell or distressed between episodes → suspect organic cause (pain, infection, metabolic). Feeding normally → reassuring. Refusing feeds → oral thrush, otitis media, oesophagitis, metabolic.

Cry character

High-pitched, inconsolable → infection, pain, neurological. Intermittent paroxysmal screams → intussusception, colic. Hoarse / stridor with cry → laryngeal pathology, croup, epiglottitis.

Associated symptoms

Vomiting (amount, force, colour): possetting (normal) vs reflux vs projectile (pyloric stenosis). Blood / bile in vomit → surgical. Diarrhoea: infection, CMPA. Constipation: Hirschsprung's, hypothyroidism, cow's milk protein allergy (CMPA).

Feeding type & duration

Breastfed: assess latch, feeding frequency, foremilk/hindmilk balance (overfeeding → lactose overload → abdominal distension + colic-like symptoms). Formula: type, preparation, volume. Mixed feeding.

Onset & duration

Age of onset: <3 weeks → physiological + colic. Under 2 months presenting with persistent projectile non-bilious vomiting → pyloric stenosis (first-born male, olive-shaped mass). After 6 months → intussusception more likely.

Wessel's Rule of Three is a traditional definition, not a required diagnostic threshold or the current Rome IV requirement — colic is a clinical description, not a pathological diagnosis. The key reassurance point is that the baby is well between episodes and feeding normally — an infant who is miserable between crying episodes does not have colic and requires further assessment. Evening clustering is the most common pattern of physiological unsettledness — it is related to circadian hormone rhythm development and cluster feeding (particularly in breastfed infants building supply), and does not represent pathology. Breastfed infants who take prolonged feeds on one breast receive more foremilk (high lactose, low fat) and less hindmilk (high fat, more satisfying) — this can cause lactose overload with abdominal distension, green frothy stools, and colic-like symptoms, managed by ensuring complete breast emptying before switching sides.

Step 3

Diagnose — Classification of Common Causes

Diagnose

Done

Most unsettled babies have one of a small number of identifiable causes. Colic is a clinical diagnosis once assessment has not identified an organic cause.

Infantile colic

Well between episodes. Feeding well. Normal examination. Peaks 4–8 weeks, improves by 3–4 months. Cause unknown — gut microbiome or peristalsis are proposed associations, not established causes; parental anxiety may amplify distress and affect coping but does not cause the infant's symptoms. Colic is not a diagnosis of pain or reflux. Clinical diagnosis after assessment

Gastro-oesophageal reflux (GOR)

GOR (physiological reflux) is common in thriving infants (happy spitter). GORD = reflux associated with troublesome symptoms or complications (NICE NG1). Do not routinely investigate or treat an infant without overt regurgitation who has only one associated symptom, such as unexplained feeding difficulty or distressed behaviour — crying alone is not reflux. Most reflux is physiological — do not over-medicate

Cow's milk protein allergy (CMPA)

Colic alone is not sufficient evidence. Consider particularly with symptoms in more than one system: eczema or urticaria; blood or mucus in stools; persistent vomiting or diarrhoea; constipation with other allergic features; feeding difficulty; faltering growth; a convincing temporal relationship with cow's milk exposure; strong personal or family atopic history. IgE-mediated (immediate — urticaria, angioedema, vomiting, wheeze) or non-IgE-mediated (delayed). An allergy-focused history is essential (NICE CG116). Non-IgE CMPA in formula fed: switch to extensively hydrolysed formula

Hunger / underfeeding

Breastfed infant with inadequate milk transfer (poor latch, tongue tie, low supply). Formula: preparation errors (over-diluting). Check weight gain — if faltering → treat cause urgently. Distinguishable from colic: feeding resolves it.

Overfeeding

More common in formula-fed infants. >150–200ml/kg/day. Abdominal distension, frequent regurgitation, discomfort. Reduce feed volume, increase frequency. Signs: weight above 91st centile, distended abdomen after feeds.

Oral thrush

White plaques on buccal mucosa (cannot be wiped off — unlike milk residue). Infant crying particularly during feeding. Maternal nipple soreness (breastfeeding). Nystatin — dose per current SPC / local formulary

Otitis media

Especially in older infants >3 months. Pulling at ears (late sign). Fever ± URTI symptoms. Infant more unsettled when lying flat. Otoscopy: bulging erythematous TM. Analgesia; no or back-up antibiotic for most (NICE NG91)

Maternal diet (breastfed infants)

Maternal dairy exclusion is not a routine colic step — reserve it for a clinically suspected CMPA pathway, with nutritional advice and planned reintroduction. Do not advise routine elimination of multiple foods. Evidence weak — do not advise routinely

CMPA is significantly under-recognised in primary care — non-IgE-mediated CMPA in particular presents with a delayed, non-specific picture (colic-like crying, eczema, blood in stool) that is frequently labelled as "colic." The iMAP guideline (international Milk Allergy in Primary Care, UK-developed) provides a diagnostic and management pathway: in formula-fed infants with suspected non-IgE CMPA, undertake a time-limited elimination (generally 2–6 weeks) with dietetic support — eHF for formula-fed infants; maternal cow's-milk exclusion for breastfed infants only if clinically indicated. CMPA is confirmed only if symptoms return on planned reintroduction; do not continue an exclusion diet indefinitely without confirmation, and reassess the diagnosis if there is no response. Colic alone does not indicate CMPA. Gastro-oesophageal reflux is over-medicated in primary care — NICE NG1 (2015) strongly discourages prescribing PPIs and H2 blockers for uncomplicated infant reflux as evidence for benefit is lacking and harm (respiratory infection, altered gut microbiome) is established. Alginate preparations (Gaviscon Infant) have modest evidence for symptom reduction in GOR.

Step 4

Diagnose — Targeted Examination

Diagnose

Done

Examine the infant sufficiently to establish whether they are well and to identify common or serious causes. The extent of examination should be guided by age, severity, duration, associated symptoms and safeguarding concerns; undress the infant fully if there is concern about injury or rash. A normal examination with a well-appearing baby supports colic or benign cause.

General appearance

Alert, responsive, appropriate tone vs floppy / lethargic / inconsolable. Colour: pink vs pale vs mottled vs cyanosed. Hydration: skin turgor, fontanelle, moist mucous membranes. Well or unwell?

Vital signs

Temperature (≥38°C in <3 months → urgent hospital/paediatric assessment per NICE NG143). HR, RR, oxygen saturation. Capillary refill time ≥3 seconds is an intermediate-risk (amber) feature — interpret alongside colour, pulse, heart rate, hydration and general appearance.

Head & fontanelle

Anterior fontanelle: normal (flat, pulsatile), bulging (raised ICP — meningitis, hydrocephalus), sunken (dehydration). Head circumference on centile chart. Skull — overlapping sutures (premature fusion).

Eyes & fundi

If abusive head trauma is suspected, immediate paediatric safeguarding assessment is required. Formal retinal examination should be arranged by the specialist team. Subconjunctival haemorrhages. Jaundice (scleral icterus).

Ears

Examine the ears when clinically indicated, particularly in an older infant with symptoms compatible with otitis media. Bulging, red, immobile TM → acute otitis media.

Mouth

White plaques (thrush). Tongue tie (lift tongue — complete vs posterior tie). Cleft palate (run finger along hard and soft palate). Natal teeth (trauma / ulceration under tongue — Riga-Fede disease).

Chest & heart

Auscultation: murmur (congenital heart disease — increased caloric demand + irritability). Tachycardia. Respiratory rate and work of breathing (recession, grunting → respiratory distress).

Abdomen

Inspect: distension. Palpate: tenderness (tense abdomen → peritonism), masses (pyloric olive — right upper quadrant after feed, Hirschsprung's loaded colon), organomegaly. Check all hernia orifices (inguinal, umbilical). Bowel sounds.

Genitalia & anus

Male: check testes bilaterally — torsion (tender swollen testis, absent cremasteric reflex → immediate emergency surgical assessment; do not delay for ultrasound). Female: labial adhesions. Anus: inspect position (digital rectal examination is not routine in primary care — only if specifically indicated, by an appropriately experienced clinician or specialist). Hair tourniquet — inspect toes and fingers (hair wrapped around digit causing ischaemia → immediate ED assessment).

Skin

Bruising in non-mobile infant — any location → physical abuse must be considered. Nappy rash (pain during nappy changes). Full skin and injury survey undressed where appropriate.

Musculoskeletal

Tone. Move all limbs passively — pain / reduced movement → fracture, joint infection. Examine hips if there are risk factors, abnormal gait/movement, asymmetry or a previously abnormal examination — Barlow/Ortolani are not a routine re-examination for all unsettled infants.

Hair tourniquet syndrome is a dangerous and easily missed cause of an inconsolable infant — a strand of hair (or occasionally thread) wraps around a toe, finger, or penis, causing progressive ischaemia. The infant is inconsolable, and the digit is swollen and discoloured. The hair may be invisible in the skin folds. All unsettled babies should have their digits inspected as part of the examination. Torsion of the testis can occur at any age including infancy — it presents as an inconsolable male infant with a tender, swollen, high-riding testis. The cremasteric reflex is absent. This is a surgical emergency — arrange immediate emergency surgical assessment and do not delay for ultrasound. Retinal haemorrhages are concerning for abusive head trauma but are not pathognomonic — they require assessment by an appropriately experienced paediatric ophthalmologist within a multidisciplinary safeguarding assessment arranged by the specialist team. Primary-care ophthalmoscopy is not a definitive test.

Step 5

Diagnose — Investigations

Diagnose

Done

No routine investigations for a well infant with typical colic and normal examination. Investigate or refer according to clinical suspicion: NICE NG143 and NG224 for fever and UTI; local paediatric/surgical pathways for vomiting, abdominal symptoms, pyloric stenosis and safeguarding.

Urine MC&S

Not needed in a well infant with typical colic and normal examination. Consider UTI when the infant is unwell, febrile, has poor feeding, vomiting, lethargy, irritability or no alternative explanation (NICE NG224). Clean catch preferred. Suspected UTI <3 months → immediate paediatric referral (NICE NG224); urine for urgent microscopy and culture

Bloods (if systemically unwell)

FBC, CRP, blood culture (if febrile or sepsis suspected). Blood glucose (hypoglycaemia — irritable, jittery). U&E: electrolyte disturbance. Bilirubin if jaundiced.

Stool

Stool culture selectively — blood or mucus, significant diarrhoea, suspected invasive infection or diagnostic uncertainty. Do not routinely test stool pH or reducing substances (not useful for presumed lactose intolerance in a term infant).

If CMPA suspected (non-IgE)

Skin prick testing and specific IgE are NEGATIVE in non-IgE CMPA — do not request. Diagnosis is clinical: time-limited elimination plus planned reintroduction. If IgE-mediated allergy is suspected from immediate urticaria, angioedema, wheeze, vomiting or anaphylaxis, arrange appropriately selected specific IgE or skin-prick testing and refer according to severity. Do not perform indiscriminate food panels, total IgE, IgG testing or atopy-patch testing. Total IgE is not useful for non-IgE CMPA

Pyloric stenosis investigation

Persistent projectile non-bilious vomiting, especially under 2 months with dehydration, weight loss or hunger after vomiting, requires same-day paediatric/surgical assessment and urgent ultrasound (interpreted by paediatric radiology using local criteria). Biochemistry: hypochloraemic hypokalaemic metabolic alkalosis. Same-day surgical referral

Skeletal survey

If physical abuse suspected — arranged by the paediatric safeguarding team according to the local child protection radiology pathway (GPs do not request). Must be done via safeguarding pathway

Do NOT routinely

Hydrogen breath test for lactose intolerance (unvalidated in infants). Endoscopy in primary care. Allergy testing (IgE panel) for suspected non-IgE CMPA. Full septic screen without clinical indication. Stool pH / reducing substances. Urine testing in a well infant with typical colic.

UTI is the most important investigation to exclude in any unwell infant — it is common in febrile infants under 3 months, frequently asymptomatic except for irritability and fever, and if untreated causes renal scarring and long-term renal damage. Clean-catch urine is the preferred collection method (parent holds nappy-free baby until they urinate into a sterile pot) — bag specimens have a high false-positive rate due to skin contamination. Pyloric stenosis investigation with USS is highly sensitive — the characteristic biochemical picture of hypochloraemic hypokalaemic metabolic alkalosis (paradoxical aciduria) occurs as the infant vomits acidic gastric content, resulting in chloride and potassium depletion with renal bicarbonate conservation. This biochemistry is not present in early disease — do not wait for it to develop before referring. Non-IgE CMPA is diagnosed clinically and by response to elimination — specific IgE testing (RAST) is positive only in IgE-mediated allergy and has no role in the non-IgE subtype (which is the more common form of infant CMPA).

Step 6

Refer — Referral Criteria & Parental Support

Refer

Done

Most unsettled babies are managed in primary care. Know when to escalate urgently, and always assess parental welfare.

999

Meningitis / sepsis signs. Bilious vomiting, marked abdominal distension or peritonism (surgical emergency). Haemodynamic compromise. Seizures. Apnoea.

Immediate ED / emergency paediatric-surgical

Fever ≥38°C in infant <3 months → urgent hospital/paediatric assessment (NICE NG143). Inconsolable + red-currant jelly stool (intussusception). Irreducible tender hernia. Hair tourniquet. Suspected testicular torsion (immediate emergency surgical assessment — do not delay for ultrasound). Suspected abusive head trauma or serious physical abuse (with safeguarding referral). Suspected UTI in infant <3 months (immediate paediatric referral, NICE NG224).

Same-day paediatrics

Suspected pyloric stenosis (persistent projectile non-bilious vomiting under 2 months — same-day paediatric/surgical assessment + urgent USS). Infant failing to thrive + unsettled (organic cause likely).

Safeguarding referral

Any concern about physical abuse — via practice safeguarding lead/Named GP and local children's safeguarding pathway (NICE CG89); same-day paediatric assessment if injury suspected (immediate if abusive head trauma suspected). Parents expressing inability to cope / urge to harm baby — non-judgemental same-day risk assessment and safeguarding referral. Unexplained bruising in pre-mobile infant. Inconsistent history. Isolated family at risk. Document all findings contemporaneously.

Routine paediatrics

Suspected CMPA (moderate-severe) — specialist allergy pathway. Severe or complicated GORD (not responding to conservative management + significant weight loss). Complex or unclear diagnosis. Persistent unsettledness beyond 4–5 months.

Community / allied health

Health visitor: primary support for all families (feeding observation, home visit, parental wellbeing assessment). Lactation consultant (IBCLC) for breastfeeding difficulties. Perinatal mental health team if maternal PND / severe anxiety. Dietitian if CMPA / formula modification needed.

Primary care manage

Infantile colic: parental reassurance, education, feeding review, support strategies. Physiological GOR (happy spitter, normal growth): reassurance; GORD: NICE NG1 stepped approach. Oral thrush: nystatin (per SPC). AOM: analgesia ± back-up antibiotic per NICE NG91. Suspected mild non-IgE CMPA: time-limited eHF or (if indicated) maternal exclusion with dietetic support and planned reintroduction.

NICE NG143 (fever in under-5s) classes any infant under 3 months with a temperature ≥38°C as high risk — urgent hospital/paediatric assessment is required; "same-day GP/111" is only interim advice while arranging this. The rationale is that serious bacterial infection (UTI, meningitis, septicaemia) in neonates and young infants presents with minimal clinical signs, and standard assessment tools (e.g. traffic light system) have lower specificity in this age group. Parental coping must be assessed at every consultation for an unsettled baby — asking "How are you coping?" and "Do you feel safe with the baby?" is both a safeguarding and a maternal mental health intervention. More than 1 in 10 mothers develops postnatal depression — PND amplifies the distress of a crying baby and reduces parental responsiveness, creating a negative cycle. Perinatal mental health referral should be considered alongside infant management. The ICON programme (official materials at iconcope.org — not a NICE guideline) provides parental support materials designed to reduce abusive head trauma.

Step 7

Treat — Management by Cause

Treat

Done

Treat the underlying cause where identified. For colic, parental reassurance and support are the primary interventions.

Infantile Colic

Reassurance + support Primary

Explain normal developmental pattern (peaks 4–8 weeks, improves by 3–4 months). No medication has established benefit for typical colic. Simeticone is not proven to reduce crying — avoid routine prescribing (local formulary: infant colic products not routinely prescribed in primary care). Do not routinely recommend probiotics — evidence is inconsistent and product-specific.

Reflux / GORD

Conservative first NICE NG1

Formula-fed with frequent regurgitation and marked distress (NICE NG1): 1) review feeding history; 2) reduce excessive feed volumes if present; 3) offer smaller, more frequent feeds while maintaining the appropriate total daily volume; 4) trial of thickened formula; 5) if unsuccessful, stop the thickened formula and offer alginate for 1–2 weeks. Breastfed: breastfeeding assessment by someone with appropriate expertise; if symptoms persist, consider alginate for 1–2 weeks. Upright holding while awake after feeds may help, but do not use prone, side-lying, inclined or positional therapy for sleep — infants must be placed flat on their backs. Gaviscon Infant (BNFC: 1 dose — half a dual sachet — with feeds if under 4.5 kg, 2 doses if over 4.5 kg; no more than 6 times in 24 hours; breastfed: mix with cooled boiled water) — never with thickening agents or thickened formula; see safety box below. Do not prescribe PPIs or H2-receptor antagonists for isolated crying, uncomplicated regurgitation or presumed colic — consider only when GORD is clinically diagnosed with specialist/paediatric advice or a clear NICE indication. Do not prescribe domperidone, metoclopramide or erythromycin for infant reflux without specialist paediatric advice (domperidone: QT prolongation, serious ventricular arrhythmia, sudden cardiac death — MHRA).

CMPA (formula-fed)

Extensively hydrolysed formula iMAP guideline

Extensively hydrolysed formula first line (e.g. Aptamil Pepti, Nutramigen, SMA Althera) as a time-limited trial, generally 2–6 weeks. Amino-acid formula (e.g. Neocate, Puramino) reserved for severe presentations or failure/intolerance of eHF, with specialist/dietetic advice. Review, then reintroduce cow's milk to confirm the diagnosis. Prescribe on FP10. Refer to dietitian.

CMPA (breastfed)

Maternal dairy elimination if indicated 2–6 weeks

Support continuation of breastfeeding. If clinically indicated, trial maternal cow's-milk exclusion (generally 2–6 weeks) with dietetic support and calcium and vitamin D advice. Reintroduce to confirm — symptoms return → CMPA confirmed; no response → reassess the diagnosis. Do not advise routine elimination of multiple foods.

⚠️ Gaviscon Infant safety (SmPC) Not for premature infants or infants under 1 year except under medical supervision. Contraindicated in intestinal obstruction and established diarrhoea. Avoid where excessive fluid loss is likely (fever, vomiting, diarrhoea, high ambient temperature) and in known or suspected renal impairment. Do not use with thickening agents or thickened infant formula. Review after 7 days, or sooner if symptoms worsen. Excessive dosing may cause gastric distension, hypernatraemia or an intragastric mass.

⛔ Do not use for colic Dicycloverine/dicyclomine · antispasmodics · sedatives · gripe water or colic mixtures · unregulated herbal remedies · routine lactase drops · routine acid suppression · routine formula switching without a clinical indication.

Colic Step 1Parental education + reassurance: Explain normal crying pattern. Validate parental distress. Provide ICON programme materials. Written safety-net advice. Health visitor contact. Explain colic is not a diagnosis of pain or reflux and no medication has established benefit. Offer practical soothing and respite advice, breastfeeding support where relevant, and a planned review if parental distress is substantial.

Colic Step 2Feeding review: Check latch (breastfed), volume, formula preparation. Tongue tie assessment (midwife / IBCLC). Correct overfeeding or underfeeding. Maternal dairy exclusion only within a clinically suspected CMPA pathway.

Colic Step 3No routine medication: Simeticone is not proven to reduce crying — if discussed, explain the limited evidence, avoid routine prescribing and follow the specific product information (local formulary: infant colic products not routinely prescribed). Do not routinely recommend probiotics — if parents ask, explain that evidence is inconsistent and product-specific (any benefit mainly in exclusively breastfed infants); follow local prescribing and safety policies.

Oral thrushNystatin suspension: dose per current product SPC / local formulary; give after feeds and avoid immediately washing the medicine away. If breastfeeding and maternal nipple symptoms are present, treat the mother according to the relevant product guidance. Reassess if not improving; if recurrent or severe, assess for feeding difficulty, dehydration or immunodeficiency.

AOMRegular analgesia first (NICE NG91): Analgesia (paracetamol, dose by age and weight per current BNFC) is the main intervention. Most children: no antibiotic or a back-up prescription. Under 2 years with bilateral AOM, or any child with otorrhoea: consider immediate, no or back-up antibiotic. Systemically very unwell or high risk of complications: immediate antibiotic. Amoxicillin 125 mg TDS for 5–7 days (age 1–11 months) — check against the current NICE table and local antimicrobial guidance. Review if worsening or not starting to improve within 3 days; check for mastoiditis or another serious diagnosis. A febrile infant under 3 months needs urgent hospital/paediatric assessment (NICE NG143), not watchful waiting.

Next steps: see Reflux in infants · Cow's milk protein allergy · Surgical problems in children · Postnatal depression

NICE NG1 (2015) was a landmark guideline that specifically recommended against prescribing PPIs and H2-receptor antagonists for uncomplicated infant reflux — the evidence for symptom benefit is poor, and the risks (altered gut microbiome, increased respiratory infections, community-acquired pneumonia, C. difficile susceptibility) are real. Gaviscon Infant (alginate) has modest evidence for GOR symptom reduction and is a reasonable conservative measure. Evidence for Lactobacillus reuteri DSM 17938 is inconsistent and product-specific; any possible benefit appears most relevant to exclusively breastfed infants and cannot be generalised to formula-fed infants or other probiotics — do not recommend routinely. The iMAP guideline (developed by MAP — Milk Allergy in Primary care) provides clear, age-stratified management of CMPA — it is the consensus UK guideline for primary care CMPA management and should be used alongside NICE CG116 for formula switching decisions.

Step 8

Lifestyle — Parental Support, Soothing Strategies & Wellbeing

Lifestyle

Done

Parental wellbeing is an integral part of managing an unsettled baby. Practical strategies reduce distress for both infant and family.

Responsive soothing techniques Skin-to-skin contact. Gentle rhythmic motion (rocking, pram, car ride). White noise / constant sound (fan, rain sounds). Swaddling (safe technique — hips free, on the back; stop once the baby shows signs of rolling). Baby wearing in carrier.

ICON programme I — Infant crying is normal. C — Comforting methods may help (or not). O — OK to walk away safely if overwhelmed. N — Never shake a baby. Share the official ICON materials (iconcope.org) — ICON is a programme, not a NICE guideline.

Parental mental health Ask about parental mood, anxiety, bonding, sleep, coping and thoughts of self-harm or harming the infant. Use EPDS or another validated tool where appropriate, but interpret it alongside clinical assessment and local perinatal mental health pathways. Any disclosure of intent or inability to keep the infant safe requires same-day risk assessment.

Practical respite Encourage sharing care with partner / family. NSPCC helpline (for adults worried about a child) 0808 800 5000. Cry-sis helpline: 0800 448 0737 (9am–10pm, 7 days) — specifically for parents of crying babies. Normalise seeking help. Check all helpline details before use; include NHS 111/999 and local safeguarding contacts, and ensure out-of-hours arrangements are relevant to the practice.

Safe infant sleep Advise (current NHS safer-sleep advice): back to sleep on a clear, flat, separate sleep surface (no pillows/bumpers/duvets); smoke-free environment; avoid co-sleeping when exhausted or after alcohol/drugs. Car seats, sofas and armchairs are not safe routine sleep surfaces. Never use prone, side-lying or inclined positioning for sleep. SIDS risk highest 2–4 months — same period as colic peak.

Breastfeeding support IBCLC lactation consultant referral. NHS breast feeding helpline: 0300 100 0212. Local breastfeeding support group. Tongue tie assessment and division if clinically indicated. Do not advise stopping breastfeeding for colic without evidence.

Vitamin D All breastfed infants 0–1yr: vitamin D 400 IU/day (NHS recommendation). Formula-fed infants taking <500ml/day: also supplement. NHSE Healthy Start vitamins include vitamin D — free for eligible families.

Paternal / co-parent wellbeing Partners/fathers frequently overlooked. Paternal postnatal depression affects ~10% of fathers. Edinburgh scale can be used. Signpost: PANDAS Foundation (postnatal depression support). Family Together app (NHS).

The ICON programme (Infant Crying is OK Normally) is an evidence-based public health intervention developed specifically to prevent abusive head trauma. Every GP consultation for an unsettled baby should include ICON messaging. Walking away from a crying baby (placing in a safe place and stepping back for a few minutes) is safe and should be explicitly endorsed — it prevents escalation of parental frustration to harmful intervention. Co-sleeping is a significant risk factor for sudden unexpected death in infancy (SUDI) — parents of unsettled babies who are exhausted are at higher risk of bringing the baby into bed. Proactive advice about safe sleep and the specific risks of co-sleeping while fatigued or under the influence of alcohol is essential. Vitamin D deficiency in infants causes rickets and is entirely preventable — the NHS recommends 400 IU/day for all breastfed infants from birth, yet uptake remains poor. Ask at every opportunity.

Step 9

Safety — Follow-Up, Monitoring & Safety-Netting

Safety

Done

Follow-up must be individualised. Safety-netting advice must be specific and written where possible.

1–2 weeks

Early review for significant parental distress, feeding problems, weight concern or an uncertain diagnosis — review crying pattern, feeding, weight, parental wellbeing. Ask about mood and coping (EPDS where appropriate). Review after any therapeutic trial. Confirm health visitor contact.

2–6 weeks (CMPA trial)

Mandatory reassessment after the elimination trial (generally 2–6 weeks): improvement → planned cow's milk reintroduction to confirm the diagnosis (with dietetic support); symptoms return → CMPA confirmed, continue exclusion with dietetic follow-up; no response → reassess diagnosis. Do not continue exclusion indefinitely without confirmation.

6-week check

Routine 6-week GP check — assess crying resolution, weight gain, developmental milestones, maternal mental health (depression and anxiety identification questions; EPDS or PHQ-9 if concern), infant examination.

3–4 months

Colic should be resolving. If still significant crying beyond 3–4 months, or any deterioration → reassess for organic cause (CMPA, GI pathology). Refer to paediatrics if no cause found and persistent.

Growth monitoring

Weigh at all contacts with HV and GP. Feeding normally + gaining weight along centile → reassuring. Crossing centile lines down + unsettled → organic cause / inadequate intake (refer paediatrics).

Safety-net 999

Infant becomes limp / unresponsive. High-pitched or weak cry. Mottled / cyanosed. Bilious vomiting. Seizure or apnoea. Breathing difficulty. Red-currant jelly stool. Tense abdomen. Bulging soft spot (fontanelle). Rash that does not fade when a glass is pressed on it. Tense, tender swelling in the groin or scrotum (call 999 or go straight to A&E).

Safety-net same-day GP / 111

Fever ≥38°C in infant <3 months → urgent hospital/paediatric assessment (111/GP only as interim while arranging this). Feeding less than half normal. Reduced wet nappies. Projectile vomiting. Blood in stool. Abdominal distension. Lethargy. Significant deterioration in parent's ability to cope. Parents concerned something is seriously wrong — parental instinct is a valid clinical sign.

Safeguarding trigger

Missed appointments. Inconsistent history between contacts. New unexplained marks. Parent discloses thoughts of harming baby or inability to keep the infant safe → same-day risk assessment. Escalate via Named GP for Safeguarding and Local Authority Children's Services.

The safety-netting message for parents of unsettled babies must balance reassurance with clear escalation criteria — an overly reassuring message ("it's just colic") delays presentation of seriously unwell infants. Parental instinct ("something doesn't feel right") is a validated clinical sign that should always be taken seriously — parents who report a change in their baby's cry quality or behaviour should be seen promptly. The CMPA trial review (including planned reintroduction) is clinically important — partial improvement (crying reduced but not resolved, or new symptom) requires dietary reassessment with a dietitian. NICE CG192 (antenatal and postnatal mental health) recommends asking the depression identification (Whooley) and GAD-2 questions in the early postnatal period, including the 6–8 week check, and considering the EPDS or PHQ-9 as part of a fuller assessment if these are positive. The EPDS is a screening tool, not a diagnostic test — interpret any score alongside clinical interview, risk, suicidal ideation, symptoms, social circumstances and local perinatal mental health criteria. Do not discharge after the 6-week check without addressing a positive screen.