Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity

Официальное название

Comparison of Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG Raised in Closed Incubators: Impact on Body Growth and Morbidity

Обзор

Previous studies have shown that mortality and morbidity in preterm neonates are correlated with the fall in body temperature on admission. Hypothermia can be decreased by reducing body heat losses to the environment. The investigator research hypothesis is that a new calculation of the air temperature in the incubator would promote the newborn infant weight growth from the period between birth and day 10 of life compared to cutaneous mode. The secondary hypotheses assumes a decrease in the side effects usually observed in both morbidity and mortality. A software is used to calculate the body heat loss (BHL) of each individual preterm infant, and to propose a specific air temperature setting inside the incubator to reduce BHL to zero. This software has been validated in a previous pilot study (Degorre et al. 2015). This study aims to compare the energy costs of providing incubated preterm infants born between 25 and 32 weeks of gestation with homeothermia using either specific individualized air temperature control (ATC) or skin servocontrol (SSC).

Вмешательства

• Процедура air temperature control (ATC)
  Currently there are no guidelines for setting incubator parameters. The Cochrane database point out for further research (Sinclair, 2002). The investigators aim at evaluating 3 different incubator settings for the INOTHERM incubator (Mediprema, France): second parameter : air temperature control (ATC)
• Процедура skin servocontrol (SSC)
  Currently there are no guidelines for setting incubator parameters. The Cochrane database point out for further research (Sinclair, 2002). The investigators aim at evaluating 3 different incubator settings for the INOTHERM incubator (Mediprema, France): Third parameter : skin servocontrol (SSC).

Первичные конечные точки

• Change in body weight [Срок оценки: until day 10 of life]

Вторичные конечные точки (5)

• Comfort of the preterm infant [Срок оценки: until day 10 of life]
• thermal stress occurence [Срок оценки: until day 10 of life]
• humidity challenge using TEWL [Срок оценки: until day 10 of life]
• neonatal morbidity occurence [Срок оценки: until age corresponding to 40 weeks of amenorrhea]
• length of hospitalization stay [Срок оценки: until age corresponding to 40 weeks of amenorrhea or end of hospitalization]

Критерии участия

Критерии включения

• preterm infant born between 25+0 and 32+0 weeks of gestation
• preterm infant included in the study before 24 +/- 12 hours of life
• preterm infant nursed in a closed incubator
• written informed consent from his parents

Критерии исключения

• newborn infant with polymalformative syndrome
• life threatening events or serious heart disease

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

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Amiens University Hospital — Amiens

Идентификаторы

NCT: NCT03919188 · PI2018_843_0056

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗