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

University Hospital Southampton NHS Foundation Trust

Status: Not yet enrolling

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

Treatments: Other: Online parent administered questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT07121062

RHM CHI1301

360803 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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