Early or Late Cord Clamping in the Depressed Neonate

Not Applicable

Completed

• Conditions: Neonatal Disorder; Asphyxia Neonatorum
• Interventions: Procedure: Early (≤ 60 seconds) cord clamping; Procedure: Delayed (≥ 180 seconds) cord clamping

• Registration Number: NCT02727517
• Lead Sponsor: Uppsala University

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 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.

Study Timeline

• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-03-29
• Study Start: 2016-04
• Study First Posted: 2016-04-04
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Newborn in need of resuscitation measures (no or irregular breathing despite thorough drying and additional stimulation within one minute after birth)
• Gestational age ≥ 33 weeks

Exclusion Criteria

Monochorionic twins (from an ultrasound scan) or clinical evidence of twin-twin transfusion syndrome, triplets or higher order multiple pregnancy, and fetuses with known congenital malformation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early (≤ 60 seconds) cord clamping	Early (≤ 60 seconds) cord clamping	Early (≤ 60 seconds) cord clamping
Delayed cord clamping	Delayed (≥ 180 seconds) cord clamping	Delayed (≥ 180 seconds) cord clamping

Primary Outcome Measures

Name	Time	Method
Blood oxygen saturation	10 minutes after birth	Measured with a pulse oximeter

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Paropakar Maternity and Women's Hospital; 🇳🇵 Kathmandu, Nepal