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Completed

NCT Number: NCT02827409

Short-Delay Cord Clamping Compared to Extended- Delay Cord Clamping in Term Neonates That Require Resuscitation.

To determine whether performing extended delayed cord clamping in term neonates that require resuscitation improves early transition as compared to short-delayed cord clamping.

Completed

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Key information

Conditions

Placental Transfusion Anemia Anemia, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fetofetal Transfusion Hematologic Diseases Hemic and Lymphatic Diseases Infant, Newborn, Diseases

Age range

37 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

About this study

All subjects will receive delayed cord clamping. One group (short-delay) will receive up to one minute of delayed cord clamping and then will be placed either on the mother's abdomen or the life-start trolley if extensive resuscitation is required.

The second group will receive delayed cord clamping for at least 5 minutes and continue until the baby has established breathing without additional support or is stable on respiratory support (no longer received mask PPV for at least 1-2 minutes, i.e. stable on CPAP or intubated). The subject will initially be placed on the mother's abdomen or if the subject needs extensive resuscitation they will be moved to the LifeStart bed to receive resuscitation measures.

In either group if the baby is deemed to be unstable (by medical team) to be on the life-start trolley the cord will be clamped and the baby will be moved to an adjacent warmer for resuscitation.

Who can participate

Healthy volunteers accepted: No

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

  • Inclusion Criteria: Gestation 37 weeks or greater that require attendance at delivery of neonatal provider due to an at risk delivery.
  • Exclusion Criteria: Planned cesarean birth, placental abruption, multiple gestations, or known congenital anomalies.

Treatment and study plan

Short Delay Cord Clamping

Procedure

Delay cord clamping will occur for up to 1 minute. Subject will be placed on mother's abdomen for warmth and stimulation. If the subject is depressed they will be transferred to the radiant warmer for resuscitation.

Extended Delay Cord Clamping

Procedure

Extended delay cord clamping will occur for at least 5 minutes and will continue until the subjects begins breathing and/or the cord stops pulsating. Subject will be placed on mother's abdomen for warmth and stimulation. If the subject is depressed they will be transferred to the LifeStart bed for resuscitation adjacent to the mother's bedside.

Primary outcomes

  1. Cerebral tissue oxygenation

    Time frame: 12 hours of life

    The need for oxygen, positive pressure ventilation, intubation

Secondary outcomes

  1. Heart rate

    Time frame: First 5 minutes of life

    Heart rate obtained by pulse doppler, EKG, oximetry or a combination of all

  2. Oxygen saturation

    Time frame: over the first 5 minutes of life

    data will be averaged over each minute of life

  3. delivery room resuscitation

    Time frame: at birth

    did the infant require resuscitation such as stimulation to breathe, oxygen, positive pressure ventilation etc.

  4. Blood pressure

    Time frame: 12 hours of life

  5. Hemoglobin

    Time frame: First 5 minutes of life

    if Hemoglobin oximeter available

  6. Hemoglobin

    Time frame: 12 hours of life

    if Hemoglobin oximeter available

  7. Apgar Score

    Time frame: First 10 minutes of life

    1, 5 and 10 minute Apgar

  8. Arterial and Venous Umbilical Cord Blood Gases

    Time frame: At birth

  9. Need for NICU admission

    Time frame: at birth

  10. Need for hypothermia for hypoxic ischemic encepalopathy

    Time frame: at birth

    will be assessed by primary physician using defined criteria for hypothermia

  11. Hospitalization days

    Time frame: up to 24 weeks

  12. Bilirubin level

    Time frame: 12-48 hours

    by transcutaneous or serum if available. percentile on curve will be document to adjust for different time frames.

  13. Neurodevelopmental impairment

    Time frame: 12 month followup

    by Ages and Stages questionnaire or Bayley 3scales of infant and toddler development

  14. Post delivery survey

    Time frame: at birth

    Survey of practitioners (LD nurse, OB, neonatal team) about procedure

Sponsors and collaborators

Lead sponsor

Anup Katheria, M.D.

Other

Registry information

Official study title

A Randomized Controlled Trial of Short-Delay Cord Clamping as Compared to Extended- Delayed Cord Clamping in Term Neonates That Require Resuscitation.

Acronym: Term-NRIC

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2016
Registry last updated
Jun 8, 2017

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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