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

Initiation of Resuscitative Care While on Placental Circulation for Infants With Congenital Diaphragmatic Hernia - a Randomized Pilot Trial

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03094039

Acronym

INSPIRE-CDH

Enrollment

Registered

2017-03-29

Start date

2017-04-27

Completion date

2019-08-31

Last updated

2019-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Diaphragmatic Hernia

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.

Interventions

PROCEDUREVentilatory 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.

PROCEDUREImmediate 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 10 Minutes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026