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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Maximum Age: Newborn
Healthy Volunteers: f
View:

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

Locations
Other Locations
United Republic of Tanzania
Kilimanjaro Christian Medical Centre
RECRUITING
Moshi
Contact Information
Primary
Febronia L Shirima, MD
febbylaw17@gmail.com
+255714143368
Backup
Tupokigwe Jana
t.jana@kcri.ac.tz
+255784734602
Time Frame
Start Date: 2024-02-14
Estimated Completion Date: 2025-02-14
Participants
Target number of participants: 562
Treatments
Experimental: interventional arm
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.
No_intervention: control
As soon as the infant is out of the uterus normal routine care is given
Sponsors
Leads: Kilimanjaro Clinical Research Institute
Collaborators: Leiden University Medical Center

This content was sourced from clinicaltrials.gov