NCT04070560

Effects of Delayed Cord Clamping During Resuscitation of Newborn Near Term and Term Infants

SAVE (Sustained Cord Circulation Awaiting VEntilation)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Lund University · Academic / Other
• Sex: All
• Age: 35 Weeks – 42 Weeks
• Healthy volunteers: Not accepted

Summary

This study evaluates resuscitation with an intact umbilical cord compared to resuscitation with the umbilical cord cut. Half of the newborn babies in need of resuscitation will be handled while having an intact umbilical cord and half will have their umbilical cord cut.

Detailed description

The routine procedure when a newborn baby is in need of resuscitation is to cut the umbilical cord and move the baby to a designated area for resuscitation, which can include stimulation, clearing the airways, administration of oxygen and/or positive pressure ventilation by bag and mask och T-piece resuscitator. It has been suggested, and pilot studies has shown preliminary results, that keeping the umbilical cord intact while performing resuscitation may improve the babies outcome, by continued exchange of oxygen and carbon dioxide be the placenta and facilitating the neonatal pulmonary and circulatory transition. Because of the limiting length of the umbilical cord, resuscitation with an intact cord must be performed in close proximity to the mother.

Conditions

• Asphyxia Neonatorum
• Resuscitation

Interventions

Type	Name	Description
PROCEDURE	Intact cord (≥ 180 seconds) resuscitation	Resuscitation performed in near proximity to the mother with umbilical cord uncut
PROCEDURE	Early (≤ 60 seconds) cord clamping	Resuscitation performed at a designated area after umbilical cord is cut

Timeline

• Start date: 2019-09-30
• Primary completion: 2024-11-30
• Completion: 2026-12-31
• First posted: 2019-08-28
• Last updated: 2025-03-17

Locations

3 sites across 1 country: Sweden