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Early or Late Cord Clamping in the Depressed Neonate

NCT ID: NCT02727517

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-09-30

Brief Summary

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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

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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

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Neonatal Disorder Asphyxia Neonatorum

Keywords

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Resuscitation Cord clamping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Early (≤ 60 seconds) cord clamping

Early (≤ 60 seconds) cord clamping

Group Type ACTIVE_COMPARATOR

Early (≤ 60 seconds) cord clamping

Intervention Type PROCEDURE

If the infant don't breathe, the umbilical cord is clamped (≤ 60 seconds) and cut and resuscitation will be provided at a resuscitation table

Delayed cord clamping

Delayed (≥ 180 seconds) cord clamping

Group Type ACTIVE_COMPARATOR

Delayed (≥ 180 seconds) cord clamping

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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Immediate clamping Late cord clamping Deferred cord clamping Optimal cord clamping

Eligibility Criteria

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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
Minimum Eligible Age

33 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UNICEF

OTHER

Sponsor Role collaborator

Ministry of Health and Population, Nepal

OTHER_GOV

Sponsor Role collaborator

Swedish Society for Medical Research

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashish KC, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Ola Andersson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

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Paropakar Maternity and Women's Hospital

Kathmandu, , Nepal

Site Status

Countries

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Nepal

References

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Niermeyer S, Velaphi S. Promoting physiologic transition at birth: re-examining resuscitation and the timing of cord clamping. Semin Fetal Neonatal Med. 2013 Dec;18(6):385-92. doi: 10.1016/j.siny.2013.08.008. Epub 2013 Sep 19.

Reference Type BACKGROUND
PMID: 24055300 (View on PubMed)

Xodo S, Xodo L, Baccarini G, Driul L, Londero AP. Does Delayed Cord Clamping Improve Long-Term (>/=4 Months) Neurodevelopment in Term Babies? A Systematic Review and a Meta-Analysis of Randomized Clinical Trials. Front Pediatr. 2021 Apr 12;9:651410. doi: 10.3389/fped.2021.651410. eCollection 2021.

Reference Type DERIVED
PMID: 33912524 (View on PubMed)

Andersson O, Rana N, Ewald U, Malqvist M, Stripple G, Basnet O, Subedi K, Kc A. Intact cord resuscitation versus early cord clamping in the treatment of depressed newborn infants during the first 10 minutes of birth (Nepcord III) - a randomized clinical trial. Matern Health Neonatol Perinatol. 2019 Aug 29;5:15. doi: 10.1186/s40748-019-0110-z. eCollection 2019.

Reference Type DERIVED
PMID: 31485335 (View on PubMed)

Other Identifiers

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NEPRESUSC16

Identifier Type: -

Identifier Source: org_study_id