Early or Late Cord Clamping in the Depressed Neonate (NepCordIII)

Uppsala University

Status: Completed

Conditions: Neonatal Disorder; Asphyxia Neonatorum

Treatments: Procedure: Delayed (≥ 180 seconds) cord clamping; Procedure: Early (≤ 60 seconds) cord clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT02727517

NEPRESUSC16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 33 to 42 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

Early (≤ 60 seconds) cord clamping

Active Comparator group

Description:

Early (≤ 60 seconds) cord clamping

Treatment:

Procedure: Early (≤ 60 seconds) cord clamping

Delayed cord clamping

Active Comparator group

Description:

Delayed (≥ 180 seconds) cord clamping

Treatment:

Procedure: Delayed (≥ 180 seconds) cord clamping