跳至主要内容
临床试验/NCT05868980
NCT05868980已完成不适用

The Effect of Postnatal Lying Position on Cerebral Oxygenation in Newborns

Dr. Behcet Uz Children's Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
postnatal adaptation on vital parameters as heart rate for each position at delivery room

研究概览

简要总结

In the international delivery room guidelines, it is not specified which position is optimal for the baby stabilization. Here, the investigators want to evaluate the effects of the positions on postnatal adaptation and cerebral oxygenation in the delivery room of infants who did not require resuscitation.

Infants will be randomly stabilized in the supine, right-side, left-side and prone positions (60 babies in all, 15/position). The investigators will record the 1st and 5th min Apgar scores and the heart rate, pulse oximetry and perfusion index at 2nd,5th and 10thmin. Near-infrared spectroscopy will be used to assess cerebral regional oxygen saturation.

详细描述

This was a prospective, randomized, observational study performed in 2 months by the Newborn Department in the Delivery Room of the Department of Obstetrics and Gynecology where approximately 3,500 infants are delivered annually. Stabilization followed the NRP guideline and is implemented by a neonatology fellow and three pediatric assistants with NRP certificates. Single, term, appropriate for gestational age (AGA) babies who did not need resuscitation and babies in whom skin-to-skin contact cannot be applied were included in the study. Vaginal births were not included, only babies born with cesarean sectio (CS) and could not not exposed to early skin-to-skin contact were included.

Spinal anesthesia was used for the mothers for CS, mother was not given oxygen therapy until the baby came out. Parents were informed of the study prior to birth and written consent was obtained from those who were willing to participate. The babies were randomized by opening of envelopes containing positional codes and were placed supine, on the right or left side, or prone (15/group).

  1. Infant positioning:

Infants were placed under radiant heat for 10 min in the various positions; first-step resuscitation was performed in a routine manner. Infants with a need for positive pressure ventilation were excluded; all were placed supine. 2. Medical records and vital parameters:

All evaluations commenced 30 s after delivery and terminated at 10 min. For each infant, the 1st and 5th min Apgar scores were calculated by the same person, and the heart rate (HR), pulse oximetry, and perfusion index (PI) were recorded at 2nd, 5th, and 10th min using a Masimo Radical-7 pulse co-oximetry with an adhesive sensor. The probe was placed preductally (on the right wrist) and then connected to the oximetry. The fraction of inspired oxygen (FiO2) was only 0.21 ("room-air") during all the stabilization period. In line with the NRP 2015 guideline, aspiration was not routinely performed in the delivery room; the number of times that touch stimulation was required and the tactile stimulus time were recorded. Although electrocardiography (ECG) recommended in the latest guidelines and reads heart rate much faster, pulse oximetry had to be used in our study because the relationship between position and saturation and cerebral oximetry was evaluated. 3. Cerebral oxygenation:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
2 Minutes 至 10 Minutes(Child)
性别
All
接受健康志愿者

入选标准

  • born with cesarean sectio (CS) could not exposed to early skin-to-skin contact

排除标准

  • Vaginal birth

结局指标

主要结局

postnatal adaptation on vital parameters as heart rate for each position at delivery room

时间窗: 10 minutes

heart rate

near infrared spectroscopy (NIRS) for each position at delivery room

时间窗: 10 minutes

near infrared spectroscopy

fractional oxygean extraction (FOE) for each position at delivery room

时间窗: 10 minutes

fractional oxygean extraction

postnatal adaptation on vital parameters as pulseoximeter for each position at delivery room

时间窗: 10 minutes

pulseoximeter

postnatal adaptation on vital parameters as perfusion index for each position at delivery room

时间窗: 10 minutes

perfusion index

Apgar scores for each position at delivery roomat delivery room

时间窗: 5 minutes

apgar scores

次要结局

未报告次要终点

研究者

发起方
Dr. Behcet Uz Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

ezgi yangin ergon

assistant professor

Dr. Behcet Uz Children's Hospital

研究点 (1)

Loading locations...

相似试验

The Effect of Postnatal Lying Position on Cerebral... | 临床试验