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Initiation of Resuscitation While Attached to the Cord With Congenital Heart Disease (INSPIRE-CHD)

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ClinicalTrials.gov Identifier: NCT03690245
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Brief Summary:

Before birth, the placenta (a structure with many blood vessels attached to the inside of your womb) and the umbilical cord (the umbilical cord is attached to the placenta) are sending oxygen and nutrients from the mother's blood through the umbilical cord to the baby. After a baby is born the cord is clamped and babies have to start breathing and support themselves.

At the moment when a baby with congenital heart disease is born they will have their cord clamped immediately (this is called immediate cord clamping (ICC)). After ICC the clinical team will start to help a baby transition by carefully monitoring their oxygen saturation (give oxygen if needed), provide warmth, and dry and stimulate. Several animal studies have shown that clamping the cord right after birth might causes the baby to miss the benefits of receiving blood from the umbilical cord / placenta.

Delayed Cord Clamping (DCC) is when the baby stays attached to the cord for a longer time. Studies show that DCC has many benefits especially for a newborn baby, such as higher iron storage, less need for blood transfusions, and improved circulation. This can be done while the baby is breathing on its own or while we help you baby breath (this is called resuscitation).

This study aims to examine whether DCC while providing resuscitation in infants with CHD is helpful compared to immediate cord clamping.

Prior to the birth of your baby, a sealed envelope will be opened and your baby will be randomly assigned to either the DCC with resuscitation group or the ICC group. 40 babies will be enrolled into this study, 20 in each group. In the DCC group, the umbilical cord will be clamped after 120 seconds during which time your baby will receive the care he/she requires by the NICU team. In the ICC group, the umbilical cord will be clamped immediately and he/she will be brought over the resuscitation bed to be cared for by the same team.


Condition or disease Intervention/treatment Phase
Congential Absence of Heart Structure Congenital Malformation of Heart, Unspecified Hypoplastic Left Heart Syndrome TGA - Transposition of Great Arteries Hypoplastic Right Heart Syndrome Congential Malformations of Aortic Valve Congenital Heart Defect Congential Malformations of Great Arteries Procedure: Initiation of Resuscitation While Attached to the Cord Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Initiation of Resuscitation While Attached to the Cord With Congenital Heart Disease - INSPIRE-CHD
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Active Comparator: Control
Infants will have immediate cord clamping and respiratory support afterwards
Procedure: Initiation of Resuscitation While Attached to the Cord
Infants will receive active resuscitative care according to the Neonatal Resuscitation Program (NRP) guidelines including warmth, dry, suctioning, oxygen, and respiratory support using iNSPiRE platform for 120 seconds while attached to the cord.

Experimental: Initiation of Resuscitation While Attached to the Cord
Infants will receive respiratory support for 120 seconds while attached to the cord.
Procedure: Initiation of Resuscitation While Attached to the Cord
Infants will receive active resuscitative care according to the Neonatal Resuscitation Program (NRP) guidelines including warmth, dry, suctioning, oxygen, and respiratory support using iNSPiRE platform for 120 seconds while attached to the cord.




Primary Outcome Measures :
  1. Increase in heart rate [ Time Frame: At 5 minutes after birth ]


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Ages Eligible for Study:   up to 20 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants with rights or left heart congenital malformation

Exclusion Criteria:

  • Infants with no heart congenital malformation

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): NCT03690245


Locations
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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: Lisa Hornberger         
Sub-Investigator: Dalal Abdelgadir         
Sub-Investigator: Ernest Phillipos         
Sponsors and Collaborators
University of Alberta

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03690245     History of Changes
Other Study ID Numbers: Pro00069732
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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

Keywords provided by University of Alberta:
Congenital Heart Defect
Newborn

Additional relevant MeSH terms:
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Syndrome
Heart Diseases
Heart Defects, Congenital
Congenital Abnormalities
Hypoplastic Left Heart Syndrome
Transposition of Great Vessels
Disease
Pathologic Processes
Cardiovascular Diseases
Cardiovascular Abnormalities