Back to resultsInitiation of Resuscitation While Attached to the Cord With Congenital Diaphragmatic Hernia (INSPIRE-CDH)
Primary Purpose
Congenital Diaphragmatic Hernia
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ventilatory support while attached to the cord
Immediate cord clamping
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Diaphragmatic Hernia
Eligibility Criteria
Inclusion Criteria:
- Newborn infants with an antenatal diagnosed CDH.
Exclusion Criteria:
- Severe antepartum or postpartum hemorrhage.
- Any obstetrical concern.
- Lack of parental consent.
Sites / Locations
- Royal Alexandra Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ventilatory support while attached to the cord
Immediate cord clamping
Arm 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.
Infants will receive immediate cord clamping, transferred to the resuscitation table, intubated and mechanical ventilated according to our current Congenital Diaphragm Hernia protocol.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03094039
Brief Title
Initiation of Resuscitation While Attached to the Cord With Congenital Diaphragmatic Hernia
Acronym
INSPIRE-CDH
Official Title
Initiation of Resuscitative Care While on Placental Circulation for Infants With Congenital Diaphragmatic Hernia - a Randomized Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Withdrawn
Why Stopped
no patient available for 18 months
Study Start Date
April 27, 2017 (Actual)
Primary Completion Date
August 31, 2019 (Anticipated)
Study Completion Date
August 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Diaphragmatic Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ventilatory support while attached to the cord
Arm Type
Experimental
Arm 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.
Arm Title
Immediate cord clamping
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Ventilatory support while attached to the cord
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Immediate cord clamping
Intervention Description
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 Measure Information:
Title
Proportion of infants with hypotension requiring inotropes
Description
Proportion of infants with hypotension requiring inotropes in the first 24 hours after birth in the neonatal intensive care unit.
Time Frame
first 24 hours after birth
10. Eligibility
Sex
All
Maximum Age & Unit of Time
10 Minutes
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newborn infants with an antenatal diagnosed CDH.
Exclusion Criteria:
Severe antepartum or postpartum hemorrhage.
Any obstetrical concern.
Lack of parental consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Schmolzer
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Initiation of Resuscitation While Attached to the Cord With Congenital Diaphragmatic Hernia
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