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

NCT06270823 | Recruiting DMC

• 1 other identifier: NIMR/HQ/R.8a/Vol.IX/4331
• Study Type: interventional
• Target: 562
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Transient Tachypnea of the Newborn

Keywords

planned caesarean birth

Outcome Measures

Primary Outcomes (1)

• respiratory distress

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

  24 hours

Secondary Outcomes (1)

• adverse outcome of knee-to-chest flexion maneuver

  24hours

Study Arms (2)

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.

Procedure: Knee-to-chest-flexion manoeuvre

control

NO INTERVENTION

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

Interventions

Knee-to-chest-flexion manoeuvre PROCEDURE

The obstetrician will place one hand at the neck and shoulder of the baby and gently bend the infant into dorsiflexion while with the other hand bending the hips and knees against the abdomen and chest (squatting into fetal position). This holding position will be continued for 30 seconds, while compression of the umbilical cord is avoided to maintain an undisturbed umbilical circulation to and from the infant during KCF.

interventional arm

Eligibility Criteria

• Age: Up to 30 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kilimanjaro Clinical Research Institute: lead
• Leiden University Medical Center: collaborator

Study Sites (1)

Kilimanjaro Christian Medical Centre

Moshi, Kilimanjaro, P.O.Box 3010, Tanzania

RECRUITING

Related Publications (1)

• Shirima FL, Keus A, Mchome B, Mangi G, Davies I, van den Akker T, Mmbaga BT, Hooper SB, Te Pas AB. The effectiveness of knee-chest-flexion maneuver in reducing respiratory distress in elective cesarean section newborns: protocol for a randomized controlled trial. Contemp Clin Trials. 2025 Sep;156:108006. doi: 10.1016/j.cct.2025.108006. Epub 2025 Jul 11.

  PMID: 40653309 DERIVED

MeSH Terms

Conditions

Transient Tachypnea of the Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Tachypnea; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bariki Mchome, PhD

  Kilimanjaro Christian Medical Centre

  PRINCIPAL INVESTIGATOR

• Blandina T Mmbaga, PhD

  Kilimanjaro Clinical Research Institute

  PRINCIPAL INVESTIGATOR

• Febronia L Shirima, MD

  Kilimanjaro Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Febronia L Shirima, MD

CONTACT

+255714143368; febbylaw17@gmail.com

Tupokigwe Jana

CONTACT

+255784734602; t.jana@kcri.ac.tz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: February 14, 2024
• Primary Completion: February 14, 2025
• Study Completion: February 14, 2025
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months following publication. No end date
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to A.B.te\ Pas@lumc.nl. To gain access, data requestors will need to sign a data access agreement.

Locations

TA (1)