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

• ClinicalTrials.gov Identifier: NCT02727517
• Recruitment Status: Completed
• First Posted: April 4, 2016
• Last Update Posted: October 31, 2016
• Sponsor: Uppsala University
• Collaborators: UNICEF; Ministry of Health and Population, Nepal; Swedish Society for Medical Research
• Information provided by (Responsible Party): Uppsala University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Neonatal Disorder; Asphyxia Neonatorum	Procedure: Early (≤ 60 seconds) cord clamping; Procedure: Delayed (≥ 180 seconds) cord clamping	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Early or Late Cord Clamping in the Depressed Neonate - a Randomized Controlled Study in a Low-income Facility Setting for Improved Early Neonatal Outcome
• Study Start Date: April 2016
• Actual Primary Completion Date: August 2016
• Actual Study Completion Date: September 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Early (≤ 60 seconds) cord clamping; 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 Name: 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

Outcome Measures

Primary Outcome Measures :

1. Blood oxygen saturation [ Time Frame: 10 minutes after birth ]
   Measured with a pulse oximeter

Secondary Outcome Measures :

1. Blood oxygen saturation [ Time Frame: 5 minutes after birth ]
   Measured with a pulse oximeter
2. Timing of reaching > 90 % in oxygen saturation [ Time Frame: Within 10 minutes after birth ]
   Measured with a pulse oximeter
3. Newborn heart rate [ Time Frame: At 1 minute after birth ]
   Measured with a pulse oximeter (preferred), fetal heart monitor or manually
4. Newborn heart rate [ Time Frame: At 5 minutes after birth ]
   Measured with a pulse oximeter (preferred), fetal heart monitor or manually
5. Newborn heart rate [ Time Frame: At 10 minutes after birth ]
   Measured with a pulse oximeter (preferred), fetal heart monitor or manually
6. Apgar score [ Time Frame: At 1 minute after birth ]
   Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes
7. Apgar score [ Time Frame: At 5 minutes after birth ]
   Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes
8. Apgar score [ Time Frame: At 10 minutes after birth ]
   Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes
9. Pulsatility index [ Time Frame: At 5 minutes after birth ]
   Measured with a pulse oximeter
10. Pulsatility index [ Time Frame: At 10 minutes after birth ]
    Measured with a pulse oximeter
11. Timing of establishing spontaneous breathing [ Time Frame: Within 10 minutes after birth ]
    Assessed by staff present
12. Timing of first cry [ Time Frame: Within 10 minutes after birth ]
    Assessed by staff present
13. Timing of moving baby from mother to resuscitation table (if applicable [ Time Frame: Within 10 minutes after birth ]
    Assessed by staff present
14. Rectal temperature [ Time Frame: At 30 minutes after birth ]
    Assessed by staff present

Other Outcome Measures:

1. Presence at one day of age [ Time Frame: 24 hours ]
   The place of stay for newborn at one day of age

Eligibility Criteria

• Ages Eligible for Study: 33 Weeks to 42 Weeks (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Nepal

Paropakar Maternity and Women's Hospital

Kathmandu, Nepal, 44600

Sponsors and Collaborators

Uppsala University

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

More Information

Publications:

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. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Andersson O, Rana N, Ewald U, Målqvist 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.

• Responsible Party: Uppsala University
• ClinicalTrials.gov Identifier: NCT02727517
• Other Study ID Numbers: NEPRESUSC16
• First Posted: April 4, 2016
• Last Update Posted: October 31, 2016
• Last Verified: October 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Uppsala University:

Resuscitation; Cord clamping

Additional relevant MeSH terms:

Asphyxia Neonatorum; Infant, Newborn, Diseases; Asphyxia; Death; Pathologic Processes; Wounds and Injuries