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Набор скоро начнётся NCT07121062

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

Наблюдательное Colic, Infantile Milk Allergy, Cow's Gastro Oesophageal Reflux Disease Atopic Dermatitis (Eczema)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Online parent administered questionnaire.
Кому может быть актуально
Состояния в реестре: Colic, Infantile, Milk Allergy, Cow's, Gastro Oesophageal Reflux Disease, Atopic Dermatitis (Eczema). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Validation Of A Parent Administered Symptom Score For Unsettled Infants

Обзор

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.

Вмешательства

  • Другое Online parent administered questionnaire
    Unsettled Infant Questionaire (UnIQue)

Первичные конечные точки

  • Validation of the questionnaire by assessment of construct validity [Срок оценки: Questionnaire reviews symptoms in last week]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Великобритания · 1 центр
  • University Hospitals Southampton NHS Foundation Trust — Southampton

Идентификаторы

NCT: NCT07121062 · RHM CHI1301 · 360803

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗