NCT02727517

Early or Late Cord Clamping in the Depressed Neonate

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 33 Weeks – 42 Weeks
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Neonatal Disorder
• Asphyxia Neonatorum

Interventions

Type	Name	Description
PROCEDURE	Early (≤ 60 seconds) cord clamping	If the infant don't breathe, the umbilical cord is clamped (≤ 60 seconds) and cut and resuscitation will be provided at a resuscitation table
PROCEDURE	Delayed (≥ 180 seconds) cord clamping	If the infant don't breathe, the umbilical cord is not clamped and cut until after 180 seconds. Initial resuscitation will be provided bedside to the mother

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-08-01
• Completion: 2016-09-01
• First posted: 2016-04-04
• Last updated: 2016-10-31

Locations

1 site across 1 country: Nepal