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Идёт набор NCT06226051

Growing Little PEAPODS Study

— Наблюдательное Premature Birth Premature Infant Premature Intrauterine Growth Restriction

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: PEAPOD Infant Body Composition measuring device.
Кому может быть актуально
Состояния в реестре: Premature Birth, Premature Infant, Premature, Intrauterine Growth Restriction. Базовые параметры: 22 Weeks — 32 Weeks · 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

Growing Little PEAPODS Study: Association Between Prematurity and Body Composition, Nutrition Practices, and Neurodevelopmental Outcomes

Обзор

The goal of this clinical trial is to learn more about how the food and nutrition babies receive while in the Neonatal Intensive Care Unit (NICU) influences their ability to gain weight and fat-free mass, and their future growth and development. Participants will: * have body growth measurements collected using the PEAPOD device * have nutritional information collected, and * be followed for neurodevelopmental outcomes Participants can expect to be in the study for 36 months.

Вмешательства

  • Устройство PEAPOD Infant Body Composition measuring device
    PEAPOD is a device to that collects body composition measurements.

Первичные конечные точки

  • To evaluate the correlation between nutritional intake over the first two weeks of life and the percent increase in fat-free mass measured by the PEAPOD [Срок оценки: Birth to 2 weeks]
  • To evaluate the correlation between higher nutritional intake in the first 2 weeks of life and the General Movement Assessment (GMA) and/or the Bayley Scales of Infant and Toddler Developmental Scores (Bayley) [Срок оценки: Birth to 36 months]
  • To evaluate the correlation between the percent increase in fat-free mass and the GMA and/or Bayley scores. [Срок оценки: Birth to 36 months]

Критерии участия

Neonate Inclusion Criteria:

  • Born inpatient at Meriter Hospital, Inc. at or above 22 gestational weeks. Upper limit is 32 weeks 6 days GA (possible gestational age range from 22w0d-32w6d)

Neonate Exclusion Criteria:

  • Known genetic condition that impacts neurodevelopmental outcomes or brain structure development
  • Multiple major congenital anomalies
  • Per the investigator's opinion, the subject will likely require transfer to American Family Children's Hospital (AFCH) before 36 weeks PMA
  • Any neonate who enrolls in the study and then unexpectedly requires transfer to AFCH before 36 weeks PMA will be excluded from the study if they are unable to obtain at least one body composition measurement before transfer. Body composition data points can only be collected at Meriter Hospital due to the location of PEAPOD

Birthing Parent Inclusion Criteria:

  • Birthing parent must speak English or Spanish due to consent documents
  • Able to understand and willing to sign a written informed consent document
  • Primary caregiver of a neonate who is eligible to participate in the study
  • Agrees to enroll neonate into the study
  • Willing to comply with all study procedures and be available for the duration of the study
  • Age 15 or older

Birthing Parent Exclusion Criteria:

  • Subject is unable to provide informed consent, including subjects in foster care and subjects within state custody
  • Does not plan to maintain custody of the child after birth, such as in instances of adoption or surrogacy

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Meriter Hospital, Inc. — Madison

Идентификаторы

NCT: NCT06226051 · 2023-0931 · A536757 · SMPH/PEDIATRICS/PEDIATRICS · Protocol Version 9/11/2024 · 2023-023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗