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

NCT ID: NCT07121062

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-08-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Online parent administered questionnaire

Unsettled Infant Questionaire (UnIQue)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Consent to complete the anonymous questionnaire

2. Parent 18 years old or over

3. Parent of an infant aged under 12 months old at time of questionnaire completion

Exclusion Criteria

1. Parent does not consent to complete the anonymous questionnaire

2. Parent under 18 years old

3. Parent of an infant aged 12 months or older at time of questionnaire completion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospitals Southampton NHS Foundation Trust

Southampton, , United Kingdom

Countries

United Kingdom

Central Contacts

Michel Erlewyn-Lajeunesse, BSc MBBS DM FRCPCH

Role: CONTACT

mich.lajeunesse@soton.ac.uk

+44 23 8120 4335

Mandy Ross

Role: CONTACT

sponsor@uhs.nhs.uk

Facility Contacts

Mich Lajeunesse, DM

Role: primary

mich.lajeunesse@soton.ac.uk

07471125159

Mandy Ross

Role: backup

sponsor@uhs.nhs.uk

Other Identifiers

360803

Identifier Type: OTHER

Identifier Source: secondary_id

RHM CHI1301

Identifier Type: -

Identifier Source: org_study_id