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Completed

NCT Number: NCT02727517

Early or Late Cord Clamping in the Depressed Neonate

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.

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Key information

Conditions

Neonatal Disorder Asphyxia Neonatorum Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases

Age range

33 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paropakar Maternity and Women's Hospital

Kathmandu, 44600, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early (≤ 60 seconds) cord clamping

Procedure

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 names: Immediate clamping

Delayed (≥ 180 seconds) cord clamping

Procedure

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 outcomes

  1. Blood oxygen saturation

    Time frame: 10 minutes after birth

    Measured with a pulse oximeter

Secondary outcomes

  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 outcomes

  1. Presence at one day of age

    Time frame: 24 hours

    The place of stay for newborn at one day of age

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Ministry of Health and Population, Nepal
  • Swedish Society for Medical Research
  • UNICEF

Registry information

Official study 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

Acronym: NepCordIII

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2016
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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