Intraventricular Hemorrhage in Kangaroo Care vs. Incubator Care

Официальное название

Kangaroo Care in Extremely Preterm Newborns Versus Incubator Care and Intraventricular Hemorrhage: A Multicenter RCT

Обзор

This clinical study aims to find out whether kangaroo care (skin-to-skin contact between parents and their extremely premature newborns) can help protect the babies' brains by reducing the risk of bleeding in the brain during the first days of life. To do this, the extremely premature newborns will be randomly assigned to one of three groups: kangaroo care in a side-lying position, kangaroo care in a face-down position, or standard care in an incubator. Researchers will monitor the babies for signs of brain bleeding and other health measures to determine which approach is safest. The main hypothesis is that kangaroo care in the side-lying position may lower the risk of severe brain bleeding compared with the other positions or remaining in the incubator.

Подробное описание

This protocol describes a multicenter, randomized, parallel-group clinical trial designed to evaluate the safety and effects of early kangaroo care on cerebral stability in extremely preterm newborns during the first 72 hours of life. Participants will be randomly assigned to one of three postural management strategies: side-lying kangaroo care, prone kangaroo care, or conventional incubator care. The study includes standardized implementation of the intervention across centers, serial clinical and neurological monitoring, as well as brain imaging and noninvasive cerebral oxygenation monitoring to assess the physiological effects associated with each position. Analyses will follow the intention-to-treat principle, comparing safety and clinical outcomes between groups while adjusting for relevant perinatal factors. The design incorporates quality control procedures, staff training, blinded image assessment, and ethical and regulatory safeguards to ensure methodological rigor and patient protection.

Вмешательства

• Процедура Lateral
  lateral Kangaroo care position: The preterm infant will be placed unclothed against the parent's chest in a side-lying position, aligned along the midline.
• Процедура Prone
  prone kangaroo care position: The preterm infant will be positioned prone against the parent's chest, upright, with the head turned 90° to one side.
• Процедура Incubator care
  Kangaroo care will not be provided during the first three days of life, and the infant will remain in the incubator.

Первичные конечные точки

• Severe Intraventricular hemorrhage [Срок оценки: HIV appearance: from before 6 hours of life to at least 7 days of life]

Критерии участия

Критерии включения

• Preterm infants born at 28 weeks of gestational age or less, admitted to the NICU and born at the study center (inborn), less than 72 hours old, with a parent or legal guardian present who is willing to provide kangaroo care.

Критерии исключения

• Preterm infants in the immediate postoperative period following major surgery.
• Preterm infants with congenital abdominal wall malformations.
• Preterm infants requiring immobilization.
• Preterm infants who are clinically unstable and unable to tolerate kangaroo care.
• Preterm infants whose parents decline participation 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

Лечение

Центры проведения

Испания · 1 центр

• Hospital Universitario 12 de Octubre — Madrid

Идентификаторы

NCT: NCT07473882 · KANVIH_25/711 · PI25/01534

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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