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

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ClinicalTrials.gov Identifier: NCT03094039
Recruitment Status : Recruiting
First Posted : March 29, 2017
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
University of Alberta

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.


Condition or disease Intervention/treatment Phase
Congenital Diaphragmatic Hernia Procedure: Ventilatory support while attached to the cord Procedure: Immediate cord clamping Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Initiation of Resuscitative Care While on Placental Circulation for Infants With Congenital Diaphragmatic Hernia - a Randomized Pilot Trial
Actual Study Start Date : April 27, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019


Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Proportion of infants with hypotension requiring inotropes [ Time Frame: 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.



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Ages Eligible for Study:   up to 10 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newborn infants with an antenatal diagnosed CDH.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094039


Contacts
Contact: Georg Schmolzer +17807354647 georg.schmoelzer@me.com

Locations
Canada, Alberta
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Georg SCHMOLZER    7807354660    georg.schmoelzer@me.com   
Principal Investigator: Georg Schmolzer         
Sub-Investigator: Po-Yin Cheung         
Sub-Investigator: Sylvia van Os         
Sub-Investigator: Caroline Fray         
Sub-Investigator: Ernest Phillipos         
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Georg Schmolzer University of Alberta

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03094039     History of Changes
Other Study ID Numbers: Pro00069729
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hernia
Hernia, Diaphragmatic
Hernias, Diaphragmatic, Congenital
Pathological Conditions, Anatomical
Congenital Abnormalities