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临床试验/NCT07121062
NCT07121062尚未招募不适用

Validation Of A Parent Administered Symptom Score For Unsettled Infants

University Hospital Southampton NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
350
试验地点
1
主要终点
Validation of the questionnaire by assessment of construct validity

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Validation of the questionnaire by assessment of construct validity

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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