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Идёт набор NCT05361122

Prevention of Developmental Delay and Xylitol (PDDaX) Study

Без фазы С лечением Prematurity Neurodevelopmental Disorders

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: Maternal Use of Xylitol Chewing Gum During Pregnancy, No Maternal Xylitol Chewing Gum Use During Pregnancy.
Кому может быть актуально
Состояния в реестре: Prematurity, Neurodevelopmental Disorders. Базовые параметры: 4 лет — 8 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
Malawi
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goals of this study are to: evaluate and validate the low-cost, transportable, easily-administered Malawi Developmental Assessment Tool (MDAT) for neurodevelopmental assessment of children aged 4-8 years old in Malawi, as compared to the gold-standard yet more cumbersome and costly Kaufman Assessment Battery for Children-II (KABC-II) among (1) n=500 formerly preterm children and (2) n=500 formerly term children. Additionally, we will evaluate the effects of gestational xylitol exposure compared to a lack of gestational xylitol exposure on neurodevelopmental outcomes of children aged 4-8 years old in Malawi through the following four neurodevelopmental tests: (3) KABC-II (cognitive outcomes), (4) EF Touch (executive functions), (5) Strengths and Difficulties Questionnaire (social-emotional outcomes), and (6) MDAT (motor and cognitive outcomes). The researchers will leverage subjects who completed the parent Prevention of Prematurity and Xylitol Trial, which enrolled 10069 pregnant individuals in Malawi and demonstrated a significant 24% reduction in incidence of preterm birth and low birthweight offspring in gravidae who chewed xylitol-containing chewing gum compared to those who did not. By ensuring that these offspring did not have higher rates of neurodevelopmental impairment, the study will promote promising multi-center international and domestic trial evaluating the impact of xylitol-containing chewing gum use and optimal dosage during pregnancy.

Вмешательства

  • Пищевая добавка Maternal Use of Xylitol Chewing Gum During Pregnancy
    There are no current interventions within this follow-up study. However, the mothers enrolled in the parent PPaX trial received xylitol-containing chewing gum (1 gram per stick of gum and instructed to chew 1-2 sticks of gum twice daily for a total dose of 2-4 grams/day of xylitol throughout pregnancy starting pre-conception or at \<20 weeks gestation).
  • Пищевая добавка No Maternal Xylitol Chewing Gum Use During Pregnancy
    There are no current interventions within this follow-up study. Children born to mothers who received access to a dentist and prenatal education (oral health, prevention of preterm birth) are in the active comparator group

Первичные конечные точки

  • Validation of the MDAT in Former Preterm Children [Срок оценки: 1 month (1-2 clinic visits)]
  • Validation of the MDAT in Former Term Children [Срок оценки: 1 month (1-2 clinic visits)]
  • KABC-II mental processing index [Срок оценки: 1 month (1-2 clinic visits)]
  • EF Touch composite score [Срок оценки: 1 month (1-2 clinic visits)]
  • SDQ composite [Срок оценки: 1 month (1-2 clinic visits)]
  • MDAT composite neurodevelopmental outcome [Срок оценки: 1 month (1-2 clinic visits)]
Вторичные конечные точки (4)
  • Incidence of cognitive delay per specific KABC-II subdomain [Срок оценки: 1 month (1-2 clinic visits)]
  • Incidence of executive function delay per specific EF Touch subdomains [Срок оценки: 1 month (1-2 clinic visits)]
  • Incidence of social-emotional delay per specific SDQ subdomains [Срок оценки: 1 month (1-2 clinic visits)]
  • Incidence of neurodevelopmental delay as per MDAT subdomains [Срок оценки: 1 month (1-2 clinic visits)]

Критерии участия

Критерии включения

  • Child born during the PPaX trial
  • Enrollment age between 4-8 years old
  • Parental or legal guardian consent obtained
  • Willing to undergo 3 neurodevelopmental tests
  • Willing to travel to BCMF for neurodevelopmental assessment
  • Assent by the pediatric subject for participation in the study

Критерии исключения

  • Parent or legal guardian cognitively unable to provide consent
  • Child unwilling to provide assent to participate in the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Malawi · 1 центр
  • Baylor College of Medicine Children's Foundation-Malawi — Lilongwe

Публикации

  • Valentine GC, Collett B, Wallie S, Mhango J, Engmann C, Sullivan E, Seferovic M, Willoughby M, Shayo B, Walson JL, Milgrom P, Aagaard K, Juul SE. The Prevention of Developmental Delay and Xylitol (PDDaX) trial: study protocol of a nested cohort follow-up from the PPaX (Prevention of Prematurity and Xylitol) trial examining neurodevelopmental outcomes among offspring at 4-8 years of age in Malawi. PMID 41239527

Идентификаторы

NCT: NCT05361122 · STUDY00015305

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗