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

NCT07121062 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2025-08-13

No results posted yet for this study

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

Interventions

OTHER

Online parent administered questionnaire

Unsettled Infant Questionaire (UnIQue)

Sponsors & Collaborators

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07121062 on ClinicalTrials.gov