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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02727517
Recruitment Status : Completed
First Posted : April 4, 2016
Last Update Posted : October 31, 2016
Sponsor:
Collaborators:
UNICEF
Ministry of Health and Population, Nepal
Swedish Society for Medical Research
Information provided by (Responsible Party):
Uppsala University

Tracking Information
First Submitted Date  ICMJE March 29, 2016
First Posted Date  ICMJE April 4, 2016
Last Update Posted Date October 31, 2016
Study Start Date  ICMJE April 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2016)
Blood oxygen saturation [ Time Frame: 10 minutes after birth ]
Measured with a pulse oximeter
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02727517 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2016)
  • Blood oxygen saturation [ Time Frame: 5 minutes after birth ]
    Measured with a pulse oximeter
  • Timing of reaching > 90 % in oxygen saturation [ Time Frame: Within 10 minutes after birth ]
    Measured with a pulse oximeter
  • Newborn heart rate [ Time Frame: At 1 minute after birth ]
    Measured with a pulse oximeter (preferred), fetal heart monitor or manually
  • Newborn heart rate [ Time Frame: At 5 minutes after birth ]
    Measured with a pulse oximeter (preferred), fetal heart monitor or manually
  • Newborn heart rate [ Time Frame: At 10 minutes after birth ]
    Measured with a pulse oximeter (preferred), fetal heart monitor or manually
  • Apgar score [ Time Frame: At 1 minute after birth ]
    Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes
  • Apgar score [ Time Frame: At 5 minutes after birth ]
    Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes
  • Apgar score [ Time Frame: At 10 minutes after birth ]
    Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes
  • Pulsatility index [ Time Frame: At 5 minutes after birth ]
    Measured with a pulse oximeter
  • Pulsatility index [ Time Frame: At 10 minutes after birth ]
    Measured with a pulse oximeter
  • Timing of establishing spontaneous breathing [ Time Frame: Within 10 minutes after birth ]
    Assessed by staff present
  • Timing of first cry [ Time Frame: Within 10 minutes after birth ]
    Assessed by staff present
  • Timing of moving baby from mother to resuscitation table (if applicable [ Time Frame: Within 10 minutes after birth ]
    Assessed by staff present
  • Rectal temperature [ Time Frame: At 30 minutes after birth ]
    Assessed by staff present
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 29, 2016)
Presence at one day of age [ Time Frame: 24 hours ]
The place of stay for newborn at one day of age
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Early or Late Cord Clamping in the Depressed Neonate
Official Title  ICMJE Early or Late Cord Clamping in the Depressed Neonate - a Randomized Controlled Study in a Low-income Facility Setting for Improved Early Neonatal Outcome
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Neonatal Disorder
  • Asphyxia Neonatorum
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Early (≤ 60 seconds) cord clamping
    Early (≤ 60 seconds) cord clamping
    Intervention: Procedure: Early (≤ 60 seconds) cord clamping
  • Active Comparator: Delayed cord clamping
    Delayed (≥ 180 seconds) cord clamping
    Intervention: Procedure: Delayed (≥ 180 seconds) cord clamping
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2016)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 33 Weeks to 42 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Nepal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02727517
Other Study ID Numbers  ICMJE NEPRESUSC16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Uppsala University
Study Sponsor  ICMJE Uppsala University
Collaborators  ICMJE
  • UNICEF
  • Ministry of Health and Population, Nepal
  • Swedish Society for Medical Research
Investigators  ICMJE
Principal Investigator: Ashish KC, MD PhD Uppsala University
Principal Investigator: Ola Andersson, MD PhD Uppsala University
PRS Account Uppsala University
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP