Knee to chest flexion to reduce respiratory distress after elective caesarean birth: a feasibility study (REducing Lung liquid After Caesarean Section; RELACS-study)

Knee to chest flexion to reduce respiratory distress after elective caesarean birth: a feasibility study (REducing Lung liquid After Caesarean Section; RELACS-study) - ReLACS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55113

Enrollment

Registered

2021-01-26

Start date

2021-03-30

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dyspnea transient tachypnea of the newborn (TTN)

Interventions

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

Eligibility

Inclusion criteria

Inclusion criteria: Healthy term infants born after elective caesarian section.

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Primary outcome is the occurrence of a KCF performed and completed according to protocol.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)