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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

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.

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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

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727517


Locations
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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
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Principal Investigator: Ashish KC, MD PhD Uppsala University
Principal Investigator: Ola Andersson, MD PhD Uppsala University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02727517    
Other Study ID Numbers: NEPRESUSC16
First Posted: April 4, 2016    Key Record Dates
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:
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Asphyxia Neonatorum
Infant, Newborn, Diseases
Asphyxia
Death
Pathologic Processes
Wounds and Injuries