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

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

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.

Study Overview

• Status: Completed
• Conditions: Asphyxia Neonatorum; Neonatal Disorder
• Intervention / Treatment: Procedure: Early (≤ 60 seconds) cord clamping; Procedure: Delayed (≥ 180 seconds) cord clamping

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Kathmandu, Nepal, 44600
    • Paropakar Maternity and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 9 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early (≤ 60 seconds) cord clamping	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; Other Names: Immediate clamping
Active Comparator: Delayed cord clamping; Delayed (≥ 180 seconds) cord clamping	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; Other Names: Late cord clamping; Deferred cord clamping; Optimal cord clamping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood oxygen saturation	Measured with a pulse oximeter	10 minutes after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood oxygen saturation	Measured with a pulse oximeter	5 minutes after birth
Timing of reaching > 90 % in oxygen saturation	Measured with a pulse oximeter	Within 10 minutes after birth
Newborn heart rate	Measured with a pulse oximeter (preferred), fetal heart monitor or manually	At 1 minute after birth
Newborn heart rate	Measured with a pulse oximeter (preferred), fetal heart monitor or manually	At 5 minutes after birth
Newborn heart rate	Measured with a pulse oximeter (preferred), fetal heart monitor or manually	At 10 minutes after birth
Apgar score	Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes	At 1 minute after birth
Apgar score	Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes	At 5 minutes after birth
Apgar score	Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes	At 10 minutes after birth
Pulsatility index	Measured with a pulse oximeter	At 5 minutes after birth
Pulsatility index	Measured with a pulse oximeter	At 10 minutes after birth
Timing of establishing spontaneous breathing	Assessed by staff present	Within 10 minutes after birth
Timing of first cry	Assessed by staff present	Within 10 minutes after birth
Timing of moving baby from mother to resuscitation table (if applicable	Assessed by staff present	Within 10 minutes after birth
Rectal temperature	Assessed by staff present	At 30 minutes after birth

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence at one day of age	The place of stay for newborn at one day of age	24 hours

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: UNICEF; Ministry of Health and Population, Nepal; Swedish Society for Medical Research
• Investigators: Principal Investigator: Ashish KC, MD PhD, Uppsala University; Principal Investigator: Ola Andersson, MD PhD, Uppsala University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: March 29, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimate): April 4, 2016

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 28, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Resuscitation; Cord clamping
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Death; Asphyxia; Infant, Newborn, Diseases; Asphyxia Neonatorum
• Other Study ID Numbers: NEPRESUSC16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No