Reducing respiratory distress in newborns after planned caesarean births
Making Elective Caesarean Safer for Infant's Lungs by Reducing Respiratory Distress Using Knee-chest-flexion: a Randomized Controlled Trial
This study tests if a simple knee-to-chest maneuver right after planned C-sections can help newborns breathe better by reducing lung fluid buildup.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 562 (estimated) |
| Ages | N/A to 30 Minutes |
| Sex | All |
| Sponsor | Kilimanjaro Clinical Research Institute Academic / other |
| Locations | 1 site (Moshi, Kilimanjaro) |
| Trial ID | NCT06270823 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether performing a knee-to-chest flexion maneuver immediately after elective caesarean sections can reduce the incidence of transient tachypnea of the newborn (TTN) in term infants. The study hypothesizes that this maneuver can mimic the natural flexion that occurs during labor, which helps expel excess lung fluid. By comparing the outcomes of infants receiving this intervention to those receiving standard care, the trial aims to determine the effectiveness of this simple technique in improving neonatal respiratory outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born by planned caesarean section at 37-42 weeks of gestational age.
Not a fit: Patients who may not benefit include those with significant congenital malformations, maternal complications like gestational diabetes or pre-eclampsia, or those requiring immediate resuscitation.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of respiratory distress in newborns, leading to better health outcomes and reduced need for neonatal intensive care.
How similar studies have performed: While the approach of knee-to-chest flexion is novel, there is strong physiological evidence supporting the need for interventions to reduce respiratory distress in newborns after caesarean births.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants born by planned CS, 37-42 weeks gestational age Exclusion Criteria: * 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
Where this trial is running
Moshi, Kilimanjaro
- Kilimanjaro Christian Medical Centre — Moshi, Kilimanjaro, Tanzania (Recruiting)
Study contacts
- Principal investigator: Bariki Mchome, PhD — Kilimanjaro Christian Medical Centre
- Study coordinator: Febronia L Shirima, MD
- Email: febbylaw17@gmail.com
- Phone: +255714143368
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.