Initiation of Resuscitation While Attached to the Cord With Congenital Diaphragmatic Hernia (INSPIRE-CDH)

University of Alberta

Status: Withdrawn

Conditions: Congenital Diaphragmatic Hernia

Treatments: Procedure: Immediate cord clamping; Procedure: Ventilatory support while attached to the cord

Study type: Interventional

Funder types: Other

Identifiers

NCT03094039

Pro00069729

Details and patient eligibility

About

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.

Sex: All

Ages: Under 10 minutes old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newborn infants with an antenatal diagnosed CDH.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Ventilatory support while attached to the cord

Experimental group

Description:

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.

Treatment:

Procedure: Ventilatory support while attached to the cord

Immediate cord clamping

Active Comparator group

Description:

Infants will receive immediate cord clamping, transferred to the resuscitation table, intubated and mechanical ventilated according to our current Congenital Diaphragm Hernia protocol.

Treatment:

Procedure: Immediate cord clamping