Resuscitating newborn infants with the umbilical cord intact to improve oxygen delivery to the brain- a substudy of a randomised trial

Not Applicable

Completed

• Conditions: eonatal transition; Neonatal resuscitation; Birth asphyxia; Umbilical cord clamping; Cerebral haemodynamics; Neonatal transition; Reproductive Health and Childbirth - Childbirth and postnatal care; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12619000277145
• Lead Sponsor: The Royal Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-25
• Study Completion: 2021-04-20
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean blood pressure at 3-4 minutes after birth measured on the right arm using an automated neonatal blood pressure cuff. [3-4 minutes after birth]