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.
