Cerebral Haemodynamics and Oxygenation during Physiologically-based cord clamping (CHOP) for resuscitation of term and near-term infants – a sub study of the Baby-Directed Umbilical Cord Cutting (BabyDUCC) Physiology Randomised Controlled Trial

The Royal Women's Hospital0 sites55 target enrollmentFebruary 25, 2019

Overview

No summary available.

Registry

who.int

Start Date

February 25, 2019

End Date

April 20, 2021

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

The Royal Women's Hospital

•Inclusion criteria are as per the BabyDUCC trial (ACTRN12618000621213\). Infants greater than or equal to 32 weeks’ gestation, with a request for a paediatrician to attend the delivery for potential newborn distress, born at the participating centres, are eligible for inclusion. The intervention arm requires that maternal oxytocin administration will occur at between 2 and 5 minutes after delivery. Assessment of the need for early maternal oxytocin administration after delivery, and permission from the maternal care team prior to recruitment and enrolment is required.
•In addition, for this sub\-study the following additional inclusion criteria apply:
•\-Availability of additional research resources to conduct the study measurements
•\-antenatal consent for the measurements detailed above (blood pressure, doppler ultrasound, near infrared spectroscopy).

•Exclusion criteria are as per the BabyDUCC trial (ACTRN12618000621213\). We will not approach expecting mothers of monochorionic twins and multiples of \>2, fetuses with known congenital anomalies compromising cardiorespiratory transition after birth, including congenital diaphragmatic hernia, hydrops fetalis, cyanotic congenital heart defects, and airway anomalies that may compromise the ability to provide face mask PPV.
•If the maternal treatment team feels that the mother is at high risk for obstetric complications that may be exacerbated by the study intervention, and/or requires early oxytocin administration after delivery, they will not be approached for consent. Potential maternal obstetric complications that may meet criteria for exclusion from the study at the discretion of the maternal care team include abnormal placentation, suspected placental abruption, suspected uterine rupture, significant blood loss, and coagulopathy.