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Идёт набор NCT07264400

Impact of Physical Activity During Pregnancy on Cardiac Variability in Newborns

Без фазы С лечением Newborn Infant

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: Heart rate variability, Pulmonary function.
Кому может быть актуально
Состояния в реестре: Newborn Infant. Базовые параметры: 1 Day — 3 Days · 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
Франция
Следующий шаг
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Обзор

Ancillary study of the PregMouv study which aims to evaluate an intervention allowing the best adherence of women in terms of physical activity. Several types of interventions are therefore planned in this study: no intervention, physical activity sessions in person, by videoconference or mixed (in person and videoconference) with accelerometer assessment of the level of physical activity practiced (in the form of energy expenditure, in MET). Thus, for our ancillary study, a comparison of the cardiac variability of newborns will be carried out according to the level of physical activity practiced by the mother regardless of the intervention she benefited from within the framework of the PregMouv study. A comparison of the average saturation and the time spent below 90% saturation will be carried out via a continuous recording of saturation by oximetry. A longitudinal follow-up for the assessment of height and weight growth (from growth curves) and neurodevelopment (by clinical examination and self-questionnaire) is also planned until the child is 2 years old.

Подробное описание

Holter ECG and oximetry recording of the newborn for a minimum of 6 hours during their stay in the maternity ward, or in another perinatal sector. Evaluation at the child's 2nd birthday by collecting the height-weight curve, the 2nd birthday clinical examination and self-questionnaire, ASQ, from the parents. Blind interpretation and analysis of the results. Comparison of the results according to the mothers' level of physical activity (in MET/min/week), assessed by the accelerometer study at T2 and T3 of pregnancy. Search for correlation between the level of physical activity practiced and the child's physiological parameters.

Вмешательства

  • Другое Heart rate variability
    A Holter ECG recording will be performed on the child's second night for a minimum of 6 hours.
  • Другое Pulmonary function
    Oximetry recording will be performed on the child's second night for a minimum of 6 hours.

Первичные конечные точки

  • Heart rate variability [Срок оценки: during the child's second night.]
Вторичные конечные точки (12)
  • Heart rate variability [Срок оценки: during the child's second night]
  • Heart rate variability [Срок оценки: during the child's second night]
  • Heart rate variability [Срок оценки: during the child's second night]
  • Heart rate variability [Срок оценки: during the child's second night]
  • Heart rate variability [Срок оценки: during the child's second night]
  • Heart rate variability [Срок оценки: during the child's second night]
  • Heart rate variability [Срок оценки: during the child's second night]
  • Heart rate variability [Срок оценки: during the child's second night]
  • Respiratory function [Срок оценки: During the child's second night]
  • Respiratory function [Срок оценки: During the child's second night]
  • Respiratory function [Срок оценки: During the child's second night]
  • Height growth [Срок оценки: at 2 years old]

Критерии участия

Критерии включения

  • All newborns of mothers who participated in the PregMouv study and who have at least one piece of data for the main criterion from the PregMouv study (physical activity at T1/T2),
  • born at the Clermont Ferrand University Hospital and after parental agreement for their child to participate may be included.

Критерии исключения

  • Newborns requiring aminergic support in the first days of life,
  • making heart rate variability analysis impossible,
  • having received invasive ventilatory support that does not allow analysis of the oximetry recording.
  • Parental refusal or inability of parents to give their consent for their child to participate.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Франция · 1 центр
  • CHU de Clermont-Ferrand — Clermont-Ferrand

Идентификаторы

NCT: NCT07264400 · RBHP 2025 PAYSAL · 2025-A00329-40

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗