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Search / Trial NCT06270823

Reducing Respiratory Distress After Elective Caesarean Birth Through Knee-chest-flexion: a Randomized Controlled Trial

Launched by KILIMANJARO CLINICAL RESEARCH INSTITUTE · Feb 14, 2024

Trial Information

Current as of November 11, 2025

Recruiting

Keywords

Planned Caesarean Birth

ClinConnect Summary

This clinical trial is studying a new way to help newborns avoid breathing problems after being delivered by planned cesarean section (C-section). Sometimes, babies can have a condition called transient tachypnea of the newborn, which means they have trouble breathing because they still have fluid in their lungs. Researchers believe that by gently bending the baby’s knees toward their chest right after birth, they can help push out some of that extra fluid and make it easier for the baby to breathe. The trial will compare this knee-to-chest technique to the standard care currently provided after a C-section.

To participate in this trial, babies must be born by planned C-section between 37 and 42 weeks of pregnancy. However, some babies won’t be eligible if they have serious birth defects affecting their heart or lungs, or if their mothers had certain health conditions like diabetes or high blood pressure. The study is currently looking for participants, and if enrolled, families can expect their baby to receive either the new knee-to-chest maneuver or the usual care immediately after birth to see which method works better in preventing breathing issues.

Gender

ALL

Eligibility 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

About Kilimanjaro Clinical Research Institute

Kilimanjaro Clinical Research Institute (KCRI) is a leading clinical research organization based in Tanzania, dedicated to advancing medical science through rigorous clinical trials and research initiatives. With a focus on infectious diseases, maternal and child health, and emerging health challenges, KCRI collaborates with global partners to conduct high-quality, ethical research that adheres to international standards. The institute is committed to fostering local capacity building, ensuring community engagement, and contributing to the development of innovative healthcare solutions that address regional and global health priorities.

Locations

Moshi, Kilimanjaro, Tanzania

Patients applied

0 patients applied

Trial Officials

Bariki Mchome, PhD

Principal Investigator

Kilimanjaro Christian Medical Centre

Blandina T Mmbaga, PhD

Principal Investigator

Kilimanjaro Clinical Research Institute

Febronia L Shirima, MD

Principal Investigator

Kilimanjaro Clinical Research Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported