To test whether performing a knee-to-chest flexion (KCF) manoeuvre is feasible directly at birth in infants born after elective caesarean section (CS) and leads to clearance of excess of lung liquid.Also safety parameters for mother and child will…
ID
Source
Brief title
Condition
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the occurrence of a KCF performed and completed according to
protocol.
Secondary outcome
Safety parameters during KCF:
* Compression of the cord during KCF
* Any Hematoma on extremities, abdomen or chest within 24 hours after birth
* The occurrence a KCF where expulsion of lung liquid during KCF is observed
* The occurrence of respiratory distress (TTN, RDS, PPHN) for which respiratory
support at birth and/ or NICU admission for respiratory support in the first 24
hours of life is needed.
Other parameters:
* Breech or head delivery
* How often KCF could be performed (in total group of included patients)
* How often KCF was adequately performed (in total group of included patients)
* Duration (in seconds) between delivery of head and start of KCF
* Duration (in seconds) of KCF
- Duration (in seconds) between delivery of the head and first vigorous
breath
Background summary
We hypothesise that, considering the increasing rates of CS worldwide this
simple methode to reduce excess airway liquid in infants born after elective
CS, before the available large liquid volumes can cause respiratory problems,
has a potential to decrease the burden of respiratory problems in this group of
infants.
Study objective
To test whether performing a knee-to-chest flexion (KCF) manoeuvre is feasible
directly at birth in infants born after elective caesarean section (CS) and
leads to clearance of excess of lung liquid.
Also safety parameters for mother and child will be looked at.
Study design
Single centre prospective interventional study
Intervention
Immediately after infants are extracted from the uterus, a KCF will be
performed before vigorous breathing of the infant has commenced. The
obstetrician will place one hand in the neck and shoulder of the baby and
gently bend the infant into dorso-flexion 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 45 seconds, while compression of
the umbilical cord is avoided to maintain an undisturbed umbilical circulation
to and from the infant during KCF. The technique used will be similar to the
position an infant is held during lumbar puncture.
During KCF the infant will remain attached to the cord and receive standard
care, which means it will be covered with gauze to prevent hypothermia and be
held as close as possible to the mother. After 45 seconds the KCF will be
terminated, allowing the infant to start breathing and resuming routine care
provided to all infants after CS.
Study burden and risks
The KCF, as a so called extra-uterine contraction, is a non-invasive, short
intervention and mimicks the fetal position in which a neonate is positioned
during intra-uterine contractions. As the study population only contains
healthy term neonates, the burden and risk associated with participation is
expected to be minimal.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Healthy term infants born after elective caesarian section.
Exclusion criteria
- significant congenital malformations influencing cardiopulmonary transition,
-first born infants in twin pregnancies,
- infants where expected need for immediate cord clamping is needed
- when spontaneous contractions before CS occur
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74285.058.20 |