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NCT03094039 Clinical Trial

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

Congenital Diaphragmatic Hernia Clinical Trial

— INSPIRE-CDH  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03094039
Other study ID # Pro00069729
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 27, 2017
Est. completion date August 31, 2019

Study information
Verified date October 2019
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date August 31, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 10 Minutes
Eligibility Inclusion Criteria:

- Newborn infants with an antenatal diagnosed CDH.

Exclusion Criteria:

- Severe antepartum or postpartum hemorrhage.

- Any obstetrical concern.

- Lack of parental consent.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada Royal Alexandra Hospital Edmonton Alberta

Sponsors (1)
Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of infants with hypotension requiring inotropes Proportion of infants with hypotension requiring inotropes in the first 24 hours after birth in the neonatal intensive care unit. first 24 hours after birth
See also
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Completed NCT03314233 - Delayed Cord Clamping for Congenital Diaphragmatic Hernia N/A
Recruiting NCT04114578 - Exploratory Observational Prospective Study in Neonatal and Pediatric Congenital Diaphragmatic Hernia
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Recruiting NCT02986087 - Feto-Endoscopic Tracheal Occlusion (FETO) for Left Congenital Diaphragmatic Hernia N/A
Recruiting NCT03674372 - Fetoscopic Endoluminal Tracheal Occlusion N/A
Active, not recruiting NCT05839340 - Neurally Adjusted Ventilatory Assist for Neonates With Congenital Diaphragmatic Hernias N/A
Enrolling by invitation NCT05962346 - Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia N/A
Withdrawn NCT04186039 - Functional Evaluation of the Fetal Lung by Functional Magnetic Resonance Imaging - Blood Oxygenation Level Dependent (MRI-BOLD), in Congenital Diaphragmatic and Parietal Malformations N/A
Unknown status NCT01302977 - Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial Phase 2
Recruiting NCT03179371 - Proteomic Profiling for Congenital Diaphragmatic Hernia