Validation Of A Parent Administered Symptom Score For Unsettled Infants (Every Baby is UnIQue)

NCT07121062 | Not Yet Recruiting

• 2 other identifiers: RHM CHI1301360803
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

It's common for infants to be unsettled, especially in the first few months of life. While this is often normal, persistent symptoms can be stressful for families. Parents naturally seek explanations, and common suspected causes include colic, reflux, eczema, and cow's milk allergy (CMA). However, CMA is frequently over diagnosed, which can lead to unnecessary changes such as stopping breastfeeding or switching to expensive specialist formulas. To address this, we've developed an online questionnaire to help track and understand symptoms in unsettled infants. Our long-term goal is to use this tool to support more accurate diagnosis of CMA. Before that, we need to test and validate the questionnaire in a general population of infants, including those who are healthy and those with other temporary conditions like a recent immunisation or teething. This study involves an anonymous online survey for parents of babies under 12 months old. We aim to collect data from approximately 350 participants. The study will help us assess how well the questionnaire reflects the severity of symptoms and whether it can distinguish between healthy infants and those with underlying issues. Parents will be invited to take part using flyers with a QR code distributed in various healthcare settings, including GP clinics and children's clinics in hospital. The survey is anonymous and hosted on a secure platform. While we don't anticipate the questions to be distressing, we recognise some may touch on sensitive topics. Support resources and study team contact details will be provided. By validating this tool, we hope to improve how unsettled behaviour in infants is assessed-reducing unnecessary interventions and better supporting families and healthcare professionals.

Conditions

Colic, Infantile; Milk Allergy, Cow's; Gastro Oesophageal Reflux Disease; Atopic Dermatitis (Eczema); Constipation - Functional; Congential Hip Dysplasia

Keywords

Infantile colic; Cows milk allergy; Unsettled behaviour

Outcome Measures

Primary Outcomes (1)

• Validation of the questionnaire by assessment of construct validity

  1. Review scoring for each item and maximum and minimum overall score 2. Check internal consistency with the Cronbach alpha statistic assuming latent variables based on organ systems, reviewing the contribution of each item 3. For each item undertake factor analysis using principal component analysis and correlation matrices selecting factors based upon Eigen value \> 1. 4. Identify which items map to each factor using a component matrix 5. Explore construct validity of UnIQue in its correlation to the overall VAS ite

  Questionnaire reviews symptoms in last week

Interventions

Online parent administered questionnaire OTHER

Unsettled Infant Questionaire (UnIQue)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1\. We will recruit parents of infants from: 1. Primary care immunisation and well-baby clinics 2. Clicky hip clinics in secondary care 3. Paediatric and dietetic clinics in primary and secondary care

You may qualify if:

• Consent to complete the anonymous questionnaire
• Parent 18 years old or over
• Parent of an infant aged under 12 months old at time of questionnaire completion

You may not qualify if:

• Parent does not consent to complete the anonymous questionnaire
• Parent under 18 years old
• Parent of an infant aged 12 months or older at time of questionnaire completion

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

University Hospitals Southampton NHS Foundation Trust

Southampton, SO16 6YFD, United Kingdom

Location

MeSH Terms

Conditions

Colic; Milk Hypersensitivity; Gastroesophageal Reflux; Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Central Study Contacts

Michel Erlewyn-Lajeunesse, BSc MBBS DM FRCPCH

CONTACT

+44 23 8120 4335; mich.lajeunesse@soton.ac.uk

Mandy Ross

CONTACT

sponsor@uhs.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)