Clinical Trial: Early or Late Cord Clamping in the Depressed Neonate

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Early or Late Cord Clamping in the Depressed Neonate - a Randomized Controlled Study in a Low-income Facility Setting for Improved Early Neonatal Outcome

Brief Summary: This study evaluates the hypothesis that delayed compared to early umbilical cord clamping will improve neonatal transition in terms of circulation and breathing during resuscitation.

Detailed Summary:

At the time of birth, the infant is still attached to the placenta via the umbilical cord. The infant is usually separated from the placenta by clamping the cord with two clamps. Early cord clamping has been generally advised to be carried out in the first 30 seconds after birth, regardless of whether the cord pulsation has ceased. However, arguments against early cord clamping include the reduction in the amount of placental transfusion and any associated benefits of extra blood volume, as delayed clamping allows time for a transfer of the fetal blood in the placenta to the infant at the time of birth.

The study will evaluate the effect of early versus delayed cord clamping in a low-income setting in children that do not spontaneously start to breathe. The randomized controlled trial will be carried out at Paropakar Maternity and Women's Hospital (PMWH) in Kathmandu.

The trial will fill several important gaps in relation to early and delayed cord clamping and results.


Sponsor: Uppsala University

Current Primary Outcome: Blood oxygen saturation [ Time Frame: 10 minutes after birth ]

Measured with a pulse oximeter


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Blood oxygen saturation [ Time Frame: 5 minutes after birth ]
    Measured with a pulse oximeter
  • Timing of reaching > 90 % in oxygen saturation [ Time Frame: Within 10 minutes after birth ]
    Measured with a pulse oximeter
  • Newborn heart rate [ Time Frame: At 1 minute after birth ]
    Measured with a pulse oximeter (preferred), fetal heart monitor or manually
  • Newborn heart rate [ Time Frame: At 5 minutes after birth ]
    Measured with a pulse oximeter (preferred), fetal heart monitor or manually
  • Newborn heart rate [ Time Frame: At 10 minutes after birth ]
    Measured with a pulse oximeter (preferred), fetal heart monitor or manually
  • Apgar score [ Time Frame: At 1 minute after birth ]
    Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes
  • Apgar score [ Time Frame: At 5 minutes after birth ]
    Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes
  • Apgar score [ Time Frame: At 10 minutes after birth ]
    Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes
  • Pulsatility index [ Time Frame: At 5 minutes after birth ]
    Measured with a pulse oximeter
  • Pulsatility index [ Time Frame: At 10 minutes after birth ]
    Measured with a pulse oximeter
  • Timing of establishing spontaneous breathing [ Time Frame: Within 10 minutes after birth ]
    Assessed by staff present
  • Timing of first cry [ Time Frame: Within 10 minutes after birth ]
    Assessed by staff present
  • Timing of moving baby from mother to resuscitation table (if applicable [ Time Frame: Within 10 minutes after birth ]
    Assessed by staff present
  • Rectal temperature [ Time Frame: At 30 minutes after birth ]
    Assessed by staff present


Original Secondary Outcome: Same as current

Information By: Uppsala University

Dates:
Date Received: March 29, 2016
Date Started: April 2016
Date Completion:
Last Updated: October 28, 2016
Last Verified: October 2016