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

NCT ID: NCT03094039

Last Updated: 2019-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-27

Study Completion Date

2019-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Diaphragmatic Hernia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Ventilatory support while attached to the cord

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

Immediate cord clamping

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Newborn infants with an antenatal diagnosed CDH.

Exclusion Criteria

* Severe antepartum or postpartum hemorrhage.
* Any obstetrical concern.
* Lack of parental consent.
Maximum Eligible Age

10 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Georg Schmolzer

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00069729

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Delayed Cord Clamping in VLBW Infants
NCT01222364 COMPLETED PHASE1/PHASE2
PDA Post NICU Discharge
NCT02750228 COMPLETED
Prone Positioning During Delayed Cord Clamping
NCT05507424 ACTIVE_NOT_RECRUITING NA