University Hospitals Southampton NHS Foundation Trust
Southampton, SO16 6YFD, United Kingdom
NCT Number: NCT07121062
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Southampton, SO16 6YFD, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Unsettled Infant Questionaire (UnIQue)
Time frame: Questionnaire reviews symptoms in last week
Contact information is provided by the study sponsor or research team.
Mandy Ross
CONTACT
Michel Erlewyn-Lajeunesse, BSc MBBS DM FRCPCH
CONTACT
University Hospital Southampton NHS Foundation Trust
Other
Validation Of A Parent Administered Symptom Score For Unsettled Infants
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