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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02727517
Other study ID # NEPRESUSC16
Secondary ID
Status Completed
Phase N/A
First received March 29, 2016
Last updated October 28, 2016
Start date April 2016
Est. completion date September 2016

Study information

Verified date October 2016
Source Uppsala University
Contact n/a
Is FDA regulated No
Health authority Nepal: Health Research Council
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date September 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 33 Weeks to 42 Weeks
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Intervention

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
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

Locations

Country Name City State
Nepal Paropakar Maternity and Women's Hospital Kathmandu

Sponsors (4)

Lead Sponsor Collaborator
Uppsala University Ministry of Health and Population, Nepal, Swedish Society for Medical Research, UNICEF

Country where clinical trial is conducted

Nepal, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Presence at one day of age The place of stay for newborn at one day of age 24 hours No
Primary Blood oxygen saturation Measured with a pulse oximeter 10 minutes after birth No
Secondary Blood oxygen saturation Measured with a pulse oximeter 5 minutes after birth No
Secondary Timing of reaching > 90 % in oxygen saturation Measured with a pulse oximeter Within 10 minutes after birth No
Secondary Newborn heart rate Measured with a pulse oximeter (preferred), fetal heart monitor or manually At 1 minute after birth No
Secondary Newborn heart rate Measured with a pulse oximeter (preferred), fetal heart monitor or manually At 5 minutes after birth No
Secondary Newborn heart rate Measured with a pulse oximeter (preferred), fetal heart monitor or manually At 10 minutes after birth No
Secondary Apgar score Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes At 1 minute after birth No
Secondary Apgar score Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes At 5 minutes after birth No
Secondary Apgar score Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes At 10 minutes after birth No
Secondary Pulsatility index Measured with a pulse oximeter At 5 minutes after birth No
Secondary Pulsatility index Measured with a pulse oximeter At 10 minutes after birth No
Secondary Timing of establishing spontaneous breathing Assessed by staff present Within 10 minutes after birth No
Secondary Timing of first cry Assessed by staff present Within 10 minutes after birth No
Secondary Timing of moving baby from mother to resuscitation table (if applicable Assessed by staff present Within 10 minutes after birth No
Secondary Rectal temperature Assessed by staff present At 30 minutes after birth No
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