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Not yet recruitingOBSERVATIONAL

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

This study, called 'Every Baby is UnIQue,' is testing a new online questionnaire for parents of babies under 12 months old. Many babies can be unsettled, which is often normal but can cause stress. While conditions like colic or reflux are common, cow's milk allergy is sometimes wrongly diagnosed, leading to unnecessary changes for families. Our questionnaire aims to help track a baby's symptoms more accurately. Before it can be used for diagnosis, we need to make sure it works well for all babies, both healthy ones and those with minor temporary issues like teething. By taking part in this anonymous survey, parents will help us improve how unsettled behaviour is understood and assessed, leading to better support without unnecessary treatments.

At a glance

Status
Not yet recruiting
Sponsor
University Hospital Southampton NHS Foundation Trust
Enrolment target
350
Start
01 Sep 2025
Estimated completion
01 Aug 2026

What is this study about?

It's completely normal for young babies, especially in their first few months, to be a bit unsettled and cry a lot. However, when this happens often or for long periods, it can be really tough and stressful for parents. Naturally, families look for reasons why their baby might be unsettled, and sometimes conditions like colic, reflux (where milk comes back up), eczema (a skin rash), or even an allergy to cow's milk are suspected. The problem is that cow's milk allergy is sometimes diagnosed when it's not actually present. This can lead to parents making unnecessary changes, like stopping breastfeeding or using expensive specialist formulas that might not be needed.

To help with this, we've created a new online questionnaire. Its main purpose is to help us keep track of a baby's symptoms and understand them better. Our long-term hope is that this tool will eventually lead to more accurate diagnoses of things like cow's milk allergy, so families only get the interventions they truly need. But first, we need to check that our questionnaire works properly across a wide range of babies – this includes healthy babies, those who might have temporary conditions like a recent vaccination, or even just teething discomfort.

This is where you come in. We're asking parents to complete an anonymous online survey for their baby under 12 months old. Your answers will help us see if the questionnaire is good at reflecting how severe a baby's symptoms are and if it can tell the difference between a typically healthy baby and one who might have an underlying issue contributing to their unsettled behaviour. By taking part, you'll be helping us improve how we understand and assess unsettled behaviour in babies, ultimately benefiting many families and healthcare professionals in the future.

Key takeaways

  • Help develop a new online tool for understanding unsettled baby behaviour.
  • Contribute to reducing unnecessary diagnoses of conditions like cow's milk allergy.
  • Participate by completing a secure, anonymous online questionnaire.
  • Open to parents of babies under 12 months old.
  • Your input helps improve support for families and healthcare professionals.
  • No medical recommendations are given; this is a research study.

Who may be eligible?

To take part in this study, you need to be a parent who is at least 18 years old. Your baby must be under 12 months old at the time you fill out the questionnaire. We expect you to agree to complete the anonymous survey.

Unfortunately, if you are under 18, or if your baby is already 12 months old or older, you won't be able to take part this time. Also, if you're not comfortable completing the anonymous questionnaire, then this study isn't for you.

Quick self-check
  • I am 18 years old or older.
  • My baby is under 12 months old today.
  • I am comfortable completing an anonymous online survey.
  • I am a parent or legal guardian of the baby.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll be asked to complete an anonymous online survey. You might see flyers with a QR code in places like your GP surgery or children's clinics in the hospital, which will lead you to the survey. There are no visits, assessments, or medications involved in this study. You just fill in the questionnaire online at your convenience. The total time for participation is simply the time it takes you to complete the survey.

Potential risks and benefits

By taking part, you'll be contributing to important research that aims to improve how unsettled baby behaviour is understood and managed, potentially reducing unnecessary treatments for many families in the future. While we don't expect the anonymous questions to be upsetting, we understand some topics might be sensitive. Support resources and contact details for the study team will be provided if you need them. You are free to withdraw from the survey at any point before submitting your anonymous responses.

Locations (1)

  • University Hospitals Southampton NHS Foundation Trust
    Southampton, United Kingdom

Common questions

What is 'unsettled' behaviour in babies?

This refers to babies who cry a lot, are fussy, or seem uncomfortable more often than typically expected for their age.

What is cow's milk allergy (CMA)?

CMA means a baby's immune system reacts to proteins in cow's milk, which can cause various symptoms like skin rashes, tummy problems, or reflux-like symptoms. It's different from lactose intolerance.

Will taking part help my baby directly?

This study won't provide a direct diagnosis or treatment for your baby, as it's about validating a tool. However, your anonymised information will help develop better ways to assess babies in the future.

How long will the survey take?

The survey is designed to be completed in one sitting, but the exact duration will depend on individual responses.

Is my information confidential?

Yes, the survey is completely anonymous and hosted on a secure platform. Your personal details will not be collected or linked to your responses.

How to find out more

Michel Erlewyn-Lajeunesse, BSc MBBS DM FRCPCH

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Validation Of A Parent Administered Symptom Score For Unsett…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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