Early or Late Cord Clamping in the Depressed Neonate

Asphyxia Neonatorum Clinical Trial

— NepCordIII  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727517
• Other study ID #: NEPRESUSC16
• 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

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Infant, Newborn, Diseases
• Neonatal Disorder

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