Colic, InfantileNCT07121062
Validation Of A Parent Administered Symptom Score For Unsettled Infants (Every Baby is UnIQue)
An observational study of Colic, Infantile and Milk Allergy, Cow's, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colic, Infantile, Milk Allergy, Cow's, Gastro Oesophageal Reflux Disease
- What is being tested?
- Online parent administered questionnaire
- How many people
- 350 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2025to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. We will recruit parents of infants from: 1. Primary care immunisation and well-baby clinics 2. Clicky hip clinics in secondary care 3. Paediatric and dietetic clinics in primary and secondary care
Who may be able to join
- Consent to complete the anonymous questionnaire
- Parent 18 years old or over
- Parent of an infant aged under 12 months old at time of questionnaire completion
Who cannot join
- Parent does not consent to complete the anonymous questionnaire
- Parent under 18 years old
- Parent of an infant aged 12 months or older at time of questionnaire completion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mandy Ross contact
United Kingdom1 site
University Hospitals Southampton NHS Foundation Trust
Southampton, SO16 6YFD
Mich Lajeunesse, DM, 07471125159, mich.lajeunesse@soton.ac.uk
Mandy Ross, sponsor@uhs.nhs.uk
About this study
Official title: Validation Of A Parent Administered Symptom Score For Unsettled Infants
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.
Read more
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
- Being tested
- Online parent administered questionnaire
- Keywords
- Infantile colic, Cows milk allergy, Unsettled behaviour
- Medical subject headings
- Colic, Milk Hypersensitivity, Gastroesophageal Reflux, Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online parent administered questionnaireOther
Unsettled Infant Questionaire (UnIQue)
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the questionnaire by assessment of construct validity
- Review scoring for each item and maximum and minimum overall score
- Check internal consistency with the Cronbach alpha statistic assuming latent variables based on organ systems, reviewing the contribution of each item
- For each item undertake factor analysis using principal component analysis and correlation matrices selecting factors based upon Eigen value > 1.
- Identify which items map to each factor using a component matrix
- Explore construct validity of UnIQue in its correlation to the overall VAS ite
Measured: Questionnaire reviews symptoms in last week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colic, InfantileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121062
- Sponsor's protocol ID
- RHM CHI1301
- Other IDs
- 360803
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: None collected - anonymous dataset
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Of A Parent Administered Symptom Score For Unsettled Infants
- ClinicalTrials.gov ID
- NCT07121062
- Acronym / sponsor ID
- RHM CHI1301
- Conditions
- Colic, Infantile, Milk Allergy, Cow's, Gastro Oesophageal Reflux Disease, Atopic Dermatitis (Eczema), Constipation - Functional, Congential Hip Dysplasia
- Keywords
- Infantile colic, Cows milk allergy, Unsettled behaviour
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. We will recruit parents of infants from: 1. Primary care immunisation and well-baby clinics 2. Clicky hip clinics in secondary care 3. Paediatric and dietetic clinics in primary and secondary care
Key inclusion criteria (3 listed)
- Consent to complete the anonymous questionnaire
- Parent 18 years old or over
- Parent of an infant aged under 12 months old at time of questionnaire completion
Key exclusion criteria (3 listed)
- Parent does not consent to complete the anonymous questionnaire
- Parent under 18 years old
- Parent of an infant aged 12 months or older at time of questionnaire completion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online parent administered questionnaireUnsettled Infant Questionaire (UnIQue) | Other | – |
Primary outcome
Validation of the questionnaire by assessment of construct validity
Time frame: Questionnaire reviews symptoms in last week
1. Review scoring for each item and maximum and minimum overall score 2. Check internal consistency with the Cronbach alpha statistic assuming latent variables based on organ systems, reviewing the contribution of each item 3. For each item undertake factor analysis using principal component analysis and correlation matrices selecting factors based upon Eigen value > 1. 4. Identify which items map to each factor using a component matrix 5. Explore construct validity of UnIQue in its correlation to the overall VAS ite
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No. None collected - anonymous dataset
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mandy Ross contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colic, Infantile and Milk Allergy, Cow's, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michel Erlewyn-Lajeunesse, BSc MBBS DM FRCPCH (+44 23 8120 4335, mich.lajeunesse@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the questionnaire by assessment of construct validity (time frame: Questionnaire reviews symptoms in last week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.