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

Last updated: March 14, 2025
Sponsor: Lund University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Early (≤ 60 seconds) cord clamping

Intact cord (≥ 180 seconds) resuscitation

Clinical Study ID

NCT04070560
SAVE1
  • Ages 35-42
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnancy week ≥35 + 0

  • Singletons

  • Expected vaginal delivery

  • The woman / couple can adequately assimilate information about the study

  • Signed informed consent of both prospective parents

Exclusion

Exclusion Criteria:

  • Congenital malformation that complicates resuscitation (such as severe malformationof mouth, pharynx, respiratory system) or which causes the child not to beresuscitated due to internal structural malformations (such as more severe heartfailure, diaphragm fractures, etc.)

  • The child is born via acute caesarean section after inclusion and opening of studyenvelope

  • placenta abruption / or damage to umbilical cord during childbirth (when circulationthrough an intact umbilical cord cannot be achieved after birth)

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Early (≤ 60 seconds) cord clamping
Phase:
Study Start date:
September 30, 2019
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Hospital of Halland

    Halmstad, Halland 30185
    Sweden

    Site Not Available

  • Skåne University Hospital

    Malmö, Skåne 21428
    Sweden

    Site Not Available

  • Ystad hospital

    Ystad,
    Sweden

    Site Not Available

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