Early or Late Cord Clamping in the Depressed Neonate (NepCordIII)
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ClinicalTrials.gov Identifier: NCT02727517 |
Recruitment Status :
Completed
First Posted : April 4, 2016
Last Update Posted : October 31, 2016
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Condition or disease | Intervention/treatment | Phase |
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Neonatal Disorder Asphyxia Neonatorum | Procedure: Early (≤ 60 seconds) cord clamping Procedure: Delayed (≥ 180 seconds) cord clamping | Not Applicable |
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 (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 |

Arm | Intervention/treatment |
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Active Comparator: Early (≤ 60 seconds) cord clamping
Early (≤ 60 seconds) cord clamping
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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
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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:
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- Blood oxygen saturation [ Time Frame: 10 minutes after birth ]Measured with a pulse oximeter
- 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
- Presence at one day of age [ Time Frame: 24 hours ]The place of stay for newborn at one day of age

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

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
Nepal | |
Paropakar Maternity and Women's Hospital | |
Kathmandu, Nepal, 44600 |
Principal Investigator: | Ashish KC, MD PhD | Uppsala University | |
Principal Investigator: | Ola Andersson, MD PhD | Uppsala University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Resuscitation Cord clamping |
Infant, Newborn, Diseases Asphyxia Neonatorum Asphyxia |
Death Pathologic Processes Wounds and Injuries |