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Clinical Trials/ACTRN12618000621213
ACTRN12618000621213
Completed
未知

Resuscitation of term and near-term infants with the umbilical cord intact for improving physiological transition at birth- a randomised trial.

The Royal Women's Hospital0 sites123 target enrollmentApril 20, 2018

Overview

Phase
未知
Intervention
Not specified
Conditions
eonatal transition
Sponsor
The Royal Women's Hospital
Enrollment
123
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 20, 2018
End Date
June 18, 2021
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
The Royal Women's Hospital

Eligibility Criteria

Inclusion Criteria

  • 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 (Baby\-DUCC) 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Not specified

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