Initiation of Resuscitation While Attached to the Cord With Congenital Diaphragmatic Hernia

Not Applicable

Withdrawn

• Conditions: Congenital Diaphragmatic Hernia
• Interventions: Procedure: Ventilatory support while attached to the cord; Procedure: Immediate cord clamping

• Registration Number: NCT03094039
• Lead Sponsor: University of Alberta

Brief Summary

This study aims to measure the cardio-respiratory physiological consequences of initiating resuscitation during placental transfusion (PT) with an intact umbilical cord in infants with congenital diaphragmatic hernia (CDH). PT, mainly via delayed cord clamping, has been shown to offer a higher circulating blood volume, less need for blood transfusion, less need for inotropes in infants.

Currently infants with CDH receive immediate cord clamping (ICC) to facilitate immediate resuscitation including immediate intubation and mechanical ventilation.

With the development of a resuscitation platform (iNSPiRE), resuscitative care can now be commenced from birth in infants with CDH to benefit from PT.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-03-17
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-29
• Study Start: 2017-04-27
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Newborn infants with an antenatal diagnosed CDH.

Read More

Exclusion Criteria

• Severe antepartum or postpartum hemorrhage.
• Any obstetrical concern.
• Lack of parental consent.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ventilatory support while attached to the cord	Ventilatory support while attached to the cord	Infants will receive active resuscitative care (intubation and ventilation) using a specific designed platform for 120 seconds during delayed cord clamping. Then the cord will be clamped forgoing resuscitation care.
Immediate cord clamping	Immediate cord clamping	Infants will receive immediate cord clamping, transferred to the resuscitation table, intubated and mechanical ventilated according to our current Congenital Diaphragm Hernia protocol.

Primary Outcome Measures

Name	Time	Method
Proportion of infants with hypotension requiring inotropes	first 24 hours after birth	Proportion of infants with hypotension requiring inotropes in the first 24 hours after birth in the neonatal intensive care unit.

Trial Locations

Locations (1)

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada