NCT02727517

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

March 29, 2016

Last Update Submit

October 28, 2016

Conditions

Neonatal DisorderAsphyxia Neonatorum

Keywords

ResuscitationCord clamping

Outcome Measures

Primary Outcomes (1)

  • Blood oxygen saturation

    Measured with a pulse oximeter

    10 minutes after birth

Secondary Outcomes (14)

  • Blood oxygen saturation

    5 minutes after birth

  • Timing of reaching > 90 % in oxygen saturation

    Within 10 minutes after birth

  • Newborn heart rate

    At 1 minute after birth

  • Newborn heart rate

    At 5 minutes after birth

  • Newborn heart rate

    At 10 minutes after birth

  • +9 more secondary outcomes

Other Outcomes (1)

  • Presence at one day of age

    24 hours

Study Arms (2)

Early (≤ 60 seconds) cord clamping

ACTIVE COMPARATOR

Early (≤ 60 seconds) cord clamping

Procedure: Early (≤ 60 seconds) cord clamping

Delayed cord clamping

ACTIVE COMPARATOR

Delayed (≥ 180 seconds) cord clamping

Procedure: Delayed (≥ 180 seconds) cord clamping

Interventions

Early (≤ 60 seconds) cord clampingPROCEDURE

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

Also known as: Immediate clamping
Early (≤ 60 seconds) cord clamping
Delayed (≥ 180 seconds) cord clampingPROCEDURE

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

Also known as: Late cord clamping, Deferred cord clamping, Optimal cord clamping
Delayed cord clamping

Eligibility Criteria

Age33 Weeks - 42 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paropakar Maternity and Women's Hospital

Kathmandu, 44600, Nepal

Location

Related Publications (3)

  • 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.

    PMID: 24055300BACKGROUND

  • 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.

    PMID: 33912524DERIVED

  • 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.

    PMID: 31485335DERIVED

MeSH Terms

Conditions

Infant, Newborn, DiseasesAsphyxia Neonatorum

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ashish KC, MD PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

  • Ola Andersson, MD PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 4, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

October 31, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

NE(1)