Omega Tots Long Term Follow-up
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: Docosahexaenoic Acid + Arachidonic Acid (DHA+AA), Placebo.
- Кому может быть актуально
- Состояния в реестре: Preterm Birth, Child Development. Базовые параметры: 8 лет — 10 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Long-term Effects and Safety of DHA+AA Supplementation in Toddlerhood for Children Born Preterm
Обзор
This is a continuation study to the Omega Tots trial (NCT01576783). The purpose of this study is to follow-up with participants of the original study to determine the long-term effect a daily fatty acid dietary supplement taken during toddlerhood might have on children born preterm now that they are 8.5-10.5 years old.
Подробное описание
The overall objective with the present study is to determine the long-term effects of docosahexaenoic acid (DHA) plus arachidonic acid (AA) supplementation on general cognitive ability, language, and executive function, and to examine genetic explanations for treatment effects, through one comprehensive study visit with children and parents from the Omega Tots trial cohort (NCT01576783).
Вмешательства
- Препарат Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)
200 mg DHA+ 200 mg AA per day for 6 months - Пищевая добавка Placebo
400 mg corn oil per day for 6 months
Первичные конечные точки
- General Cognitive Ability Score(Differential Ability Scales, Second Edition-DAS-II) [Срок оценки: A single study visit when the child is between 8.5 years to 10.5 years]
- Core Language Score (Clinical Evaluation of Language Fundamentals, Fifth edition-CELF-5) [Срок оценки: A single study visit when the child is between 8.5 years to 10.5 years]
- Executive Function (NIH Toolbox) [Срок оценки: A single study visit when the child is between 8.5 years to 10.5 years]
Вторичные конечные точки (12)
- Grooved Pegboard Task [Срок оценки: A single study visit when the child is between 8.5 years to 10.5 years]
- Select subtest from the Wechsler Intelligence Scales for Children, Fifth Edition (WISC-V) [Срок оценки: A single study visit when the child is between 8.5 years to 10.5 years]
- Select subtests from the Kaufman Test of Educational Achievement, Third Edition (KTEA-3) [Срок оценки: A single study visit when the child is between 8.5 years to 10.5 years]
- Anthropometrics-Body Composition (height) [Срок оценки: A single study visit when the child is between 8.5 years to 10.5 years]
- Anthropometrics-Body Composition (weight) [Срок оценки: A single study visit when the child is between 8.5 years to 10.5 years]
- Anthropometrics-Adiposity [Срок оценки: A single study visit when the child is between 8.5 years to 10.5 years]
- Behavior Rating Inventory of Executive Function, 2nd edition (BRIEF-2) [Срок оценки: A single study visit when the child is between 8.5 years to 10.5 years]
- Select subscales from the Teacher Report Form 6-18 [Срок оценки: A single study visit when the child is between 8.5 years to 10.5 years]
- Child Behavior Checklist 6-18 (CBCL) [Срок оценки: A single study visit when the child is between 8.5 years to 10.5 years]
- National Survey of Children's Health Module [Срок оценки: A single study visit when the child is between 8.5 years to 10.5 years]
- Emotion Regulation Checklist [Срок оценки: A single study visit when the child is between 8.5 years to 10.5 years]
- NIH Toolbox Friendship Fixed Form [Срок оценки: A single study visit when the child is between 8.5 years to 10.5 years]
Критерии участия
Критерии включения
- Previous participation in Omega Tots (NCT01576783).
- Current age of 8 years, 180 days to 10 years, 180 days.
Критерии исключения
- Child in custody of children's services for their window of eligibility
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
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Nationwide Children's Hospital — Columbus
Идентификаторы
NCT: NCT05191823 · 00001037 · R01HD100493