The effectiveness of knee-chest-flexion maneuver in reducing respiratory distress in elective cesarean section newborns: protocol for a randomized controlled trial

Background

Cesarean section (CS) birth is a risk factor for respiratory distress (RD) in term and near-term infants, which has been steadily increasing globally. The absence of labor has been linked to RD resulting from planned CS births. Uterine contractions contribute to the dorsiflexed position of the fetus which increases abdominal and trans-pulmonary pressure resulting in lung liquid loss via nose and mouth. We recently demonstrated the feasibility and safety of applying Knee-to-Chest Flexion (KCF), where the newborn was placed in a flexed “fetal” position, leading to lung liquid expulsion.

In this trial, the effectiveness of the KCF maneuver in reducing RD in infants delivered by planned CS will be examined.

Methods

This will be a randomized controlled two-arm trial in which 521 infants born by elective CS at 37–42 weeks gestational age will be randomized, in 1:1 ratio, to receive either a KCF maneuver or standard care, before being followed up for at least 24 h. The study will be conducted at Kilimanjaro Christian Medical Centre hospital and Mawenzi Regional Referral hospital in Tanzania. Consent will be sought from mothers scheduled for elective CS prior to randomization. The primary outcome is the occurrence of respiratory distress. Secondary outcome is admission to Neonatal Care Unit.

Discussion

This trial investigates KCF maneuver as an intervention to facilitate lung liquid clearance in newborns born by planned CS. It is anticipated to produce evidence of KCF as a highly cost effective innovation that will improve neonatal outcomes in clinical settings.

Trial registration number: ClinicalTrials.gov: NCT06270823