跳至主要内容
临床试验/NCT06270823
NCT06270823招募中不适用

Making Elective Caesarean Safer for Infant's Lungs by Reducing Respiratory Distress Using Knee-chest-flexion: a Randomized Controlled Trial

Kilimanjaro Clinical Research Institute2 个研究点 分布在 1 个国家目标入组 562 人开始时间: 2024年2月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
562
试验地点
2
主要终点
respiratory distress

研究概览

简要总结

Planned caesarean birth is a risk factor for the development of neonatal respiratory distress commonly known as transient tachypnoea of the newborn. This is due to the absence of labor physiology which facilitates the clearance of fetal lung fluid. We hypothesized that by mimicking flexion induced by uterine contractions by manually performing knee-to-chest flexion directly at birth to achieve expulsion of excess lung liquid, we could reduce the incidence of respiratory distress in term children born by planned CS.

The goal of this clinical trial is to test whether performing a knee-to-chest flexion maneuver directly after elective caesarean section will decrease the incidence of respiratory distress in term infants when compared to the standard care

详细描述

One of the major risk factors for term/near-term infants to develop respiratory distress (RD) is when they are born by elective caesarean section (CS). While this form of RD, commonly diagnosed as transient tachypnea of the newborn (TTN), is considered to be self-limiting, the severity of RD often leads to unexpected admission to the pediatric ward for respiratory support. TTN has also been associated and asthma, bronchiolitis, and other wheezing syndromes later in life. In low- and middle-income settings, where neonatal intensive care resources are limited, a considerable proportion of babies in need of respiratory support do not survive.

There is now strong physiological evidence that RD after elective cesarean section is caused by this greater volume of airway liquid present at birth, which is due to the absence of labor. During labor, uterine contractions contribute to the flexion of the fetus which increases abdominal and transpulmonary pressure. This elevates the diaphragm, resulting in lung liquid loss via nose and mouth. Flexion induced by uterine contractions could be mimicked by manually performing knee-to-chest flexion directly at birth, to achieve expulsion of excess lung liquid. When applying KCF, we essentially bring the newborn back into fetal position, similar to the holding position applied for performing lumbar puncture in neonates.

If this simple intervention has shown to improve neonatal outcome in the clinical setting, KCF will undoubtedly be an extremely cost-effective health care innovation. The maneuver is easy-to-teach to any clinician performing cesarean section. KCF will be performed conform standard gentle care and is likely to be entirely harmless. These advantages (easy-to-teach, no cost, no harm) are relevant across all settings, but may be particularly appealing in low-income settings, where neonatal follow-up and access to neonatal intensive care are often either impossible or limited. It is therefore of outmost importance to test this intervention in a larger institution adapted to performing high-quality clinical research in a low- or middle-income country.

We now hypothesize that performing a knee-to-chest flexion performed directly after birth will reduce the incidence of respiratory distress in term children born by elective caesarean section.

Objective: To test whether performing a knee-to-chest flexion (KCF) manoeuvre directly after elective CS will decrease the incidence of respiratory distress in term infants when compared to standard care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
— 至 30 Minutes(Child)
性别
All
接受健康志愿者

入选标准

  • Infants born by planned CS, 37-42 weeks gestational age

排除标准

  • infants with significant congenital malformations influencing cardiopulmonary transition
  • infants whose mother has gestational diabetes, pre-eclampsia, eclampsia
  • infants where immediate cord clamping is needed due to resuscitation of the baby or mother
  • when spontaneous contractions before the cesarean section is done.
  • KCF will not be done to infants who will start breathing instantly after being extracted from the uterus so as not to interfere with their breathing efforts

研究组 & 干预措施

control

No Intervention

As soon as the infant is out of the uterus normal routine care is given

interventional arm

Experimental

As soon as the infant is out of the uterus a Knee-to-chest flexion (KCF) maneuver is performed for 30 seconds while the infant remains attached to the cord. When applying KCF, we essentially bring the newborn back into the fetal position, flexing the knees to the chest. This is similar to the holding position applied for performing lumbar puncture in neonates. Except for KCF, the infant will receive normal routine care and there are no co-interventions.

干预措施: Knee-to-chest-flexion manoeuvre (Procedure)

结局指标

主要结局

respiratory distress

时间窗: 24 hours

newborns who have any signs of respiratory distress such as tachypnoea, nasal flaring, chest indrawing, grunting, cyanosis

次要结局

  • adverse outcome of knee-to-chest flexion maneuver(24hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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