Clinical trial NCT06270823: Reducing Respiratory Distress After Elective Caesarean Birth Through Knee-chest-flexion: a Randomized Controlled Trial
Official title: Making Elective Caesarean Safer for Infant's Lungs by Reducing Respiratory Distress Using Knee-chest-flexion: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transient Tachypnea of the Newborn
Keywords: planned caesarean birth
Lead sponsor: Kilimanjaro Clinical Research Institute
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
First posted: 2024-02-21
Enrollment: 562
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: One of the major risk factors for term/near-term infants to develop respiratory distress (RD) is when they are born by elective caesarean section (CS). While this form of RD, commonly diagnosed as transient tachypnea of the newborn (TTN), is considered to be self-limiting, the severity of RD often leads to unexpected admission to the pediatric ward for respiratory support. TTN has also been associated and asthma, bronchiolitis, and other wheezing syndromes later in life. In low- and middle-income settings, where neonatal intensive care resources are limited, a considerable proportion of babies in need of respiratory support do not survive.

There is now strong physiological evidence that RD after elective cesarean section is caused by this greater volume of airway liquid present at birth, which is due to the absence of labor. During labor, uterine contractions contribute to the flexion of the fetus which increases abdominal and transpulmonary pressure. This elevates the diaphragm, resulting in lung liquid loss via nose and mouth. Flexion induced by uterine contractions could be mimicked by manually performing knee-to-chest flexion directly at birth, to achieve expulsion of excess lung liquid. When applying KCF, we essentially bring the newborn back into fetal position, similar to the holding position applied for performing lumbar puncture in neonates.

If this simple intervention has shown to improve neonatal outcome in the clinical setting, KCF will undoubtedly be an extremely cost-effective health care innovation. The maneuver is easy-to-teach to any clinician performing cesarean section. KCF will be performed conform standard gentle care and is likely to be entirely harmless. These advantages (easy-to-teach, no cost, no harm) are relevant across all settings, but may be particularly appealing in low-income settings, where neonatal follow-up and access to neonatal intensive care are often either impossible or limited. It is therefore of outmost importance to test this intervention in a larger institution adapted to performing high-quality clinical research in a low- or middle-income country.

We now hypothesize that performing a knee-to-chest flexion performed directly after birth will reduce the incidence of respiratory distress in term children born by elective caesarean section.

Objective: To test whether performing a knee-to-chest flexion (KCF) manoeuvre directly after elective CS will decrease the incidence of respiratory distress in term infants when compared to standard care.

Study design: Single-center randomized controlled trial Study population: Infants born by elective CS, 37-42 weeks gestational age. Simple randomization will be done to assign participants in either an interventional group or a control group Intervention: As soon as the infant is out of the uterus a KCF is performed for 30 seconds while the infant remains attached to the cord. Except for KCF, the infant will receive normal routine care and there are no co-interventions.

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

Study parameters: The primary outcome is the occurrence of respiratory distress

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

In the group of term infants born after elective caesarean there is a 7% risk for respiratory distress, of which 10% is complicated by PPHN. Although KCF is a new intervention performed directly after birth for 30 seconds, the technique used is similar to the way infants are held and positioned during a lumbar puncture. As the infants in this study population are in good condition before birth and would otherwise also have been exposed to large intrathoracic pressures generated by uterine contractions during labor, we expect that there is no added risk when the maneuver is performed gently and with care. We recently demonstrated that performing KCF directly after birth is feasible and safe after elective CS. As the percentages of elective CS are increasing worldwide both in developing and developed countries, there is a large potential to reduce morbidity, admissions at NICU and pediatric wards, and healthcare costs in this group of infants.

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

Primary outcomes:
measure: respiratory distress
timeFrame: 24 hours
Secondary outcomes:
measure: adverse outcome of knee-to-chest flexion maneuver
timeFrame: 24hours
Other outcomes:
Locations:
city: Moshi
country: Tanzania
facility: Kilimanjaro Christian Medical Centre
state: Kilimanjaro
Study officials:
affiliation: Kilimanjaro Christian Medical Centre
name: Bariki Mchome, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kilimanjaro Clinical Research Institute
name: Blandina T Mmbaga, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kilimanjaro Clinical Research Institute
name: Febronia L Shirima, MD
role: PRINCIPAL_INVESTIGATOR
References: