Initiation of Resuscitation While Attached to the Cord With Congenital Heart Disease

NCT03690245 | Withdrawn

• 1 other identifier: Pro00069732
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Congenital Heart Defect; Newborn

Outcome Measures

Primary Outcomes (1)

• Increase in heart rate

  At 5 minutes after birth

Study Arms (2)

Control

ACTIVE COMPARATOR

Infants will have immediate cord clamping and respiratory support afterwards

Procedure: Initiation of Resuscitation While Attached to the Cord

Initiation of Resuscitation While Attached to the Cord

EXPERIMENTAL

Infants will receive respiratory support for 120 seconds while attached to the cord.

Procedure: Initiation of Resuscitation While Attached to the Cord

Interventions

Initiation of Resuscitation While Attached to the Cord PROCEDURE

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.

Control; Initiation of Resuscitation While Attached to the Cord

Eligibility Criteria

• Age: Up to 20 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants with rights or left heart congenital malformation

You may not qualify if:

• Infants with no heart congenital malformation

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Hypoplastic Left Heart Syndrome; Transposition of Great Vessels

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 1, 2018
• Study Start: December 18, 2018
• Primary Completion: August 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)