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Delayed Cord Clamping in VLBW Infants

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ClinicalTrials.gov Identifier: NCT01222364
Recruitment Status : Completed
First Posted : October 18, 2010
Last Update Posted : September 26, 2017
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
NICHD Neonatal Research Network

Brief Summary:
This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants. The study also tested whether delaying cord clamping by 30-35 seconds and holding the newborn approximately 10 inches below the birth canal would result in increased hematocrit at 4 hours of age.

Condition or disease Intervention/treatment Phase
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Procedure: Standard Cord Clamping Procedure: Delayed Cord Clamping Phase 1 Phase 2

Detailed Description:

This study tested the hypothesis that delaying clamping of the umbilical cord in extremely low birthweight (ELBW) infants would result in additional blood transfusion from the placenta to the baby, increasing the infant's blood volume and blood pressure. Higher blood pressure may improve blood flow to the brain that may reduce potential the risk of hypoxic ischemic encephalopathy (HIE) and/or intraventricular hemorrhage (IVH). The additional placental flow may also increase the amount of stem cells and cytokines flowing to the baby, improving immune status and reducing the risk of infection, while at the same time reducing the need for blood transfusions in the neonatal period.

This was a pilot study to test the feasibility of having obstetricians delay cord clamping for 30-45 seconds, and to confirm whether the procedure significantly increases the baby's hematocrit during the first 4 hours of life.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Delayed Cord Clamping in VLBW Infants Pilot Study
Study Start Date : June 2000
Actual Primary Completion Date : December 2000
Actual Study Completion Date : December 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Arm Intervention/treatment
Active Comparator: Standard Cord Clamping Procedure: Standard Cord Clamping
Immediate clamping (<5 seconds) of the umbilical cord after delivery.

Experimental: Delayed Cord Clamping Procedure: Delayed Cord Clamping
Clamping of the umbilical cord at 30-45 seconds after birth.




Primary Outcome Measures :
  1. Infants enrolled [ Time Frame: 6 months ]
    Number of infants enrolled in the pilot within 6 months.


Secondary Outcome Measures :
  1. Intention to treat [ Time Frame: 6 months ]
    Identify obstetricians willing to participate in randomizing subjects.

  2. Hematocrit level [ Time Frame: 4 hours of age ]
  3. Arterial blood pressure [ Time Frame: 12 hours of age ]
  4. Use of volume expansion or pressor therapy [ Time Frame: 24 hours of age ]
  5. Blood transfusions [ Time Frame: Until hospital discharge or 120 days of life ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Minute   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants born at participating centers at 24-27 weeks gestation
  • Singletons
  • Obstetrician approval for enrollment
  • Parental consent

Exclusion Criteria:

  • Prenatally diagnosed major congenital anomalies
  • Intent to withhold or withdraw care
  • Significant bleeding due to placenta previa or abruption

Information from the National Library of Medicine

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): NCT01222364


Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35249-7335
United States, Ohio
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45267
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Rhode Island
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
NICHD Neonatal Research Network
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: William Oh, MD Brown University, Women & Infants Hospital of Rhode Island
Principal Investigator: Avroy A. Fanaroff, MD Case Western Reserve University, Rainbow Babies and Children's Hospital
Principal Investigator: Edward F. Donovan, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Waldemar A. Carlo, MD University of Alabama at Birmingham

Additional Information:
Responsible Party: William Oh, Lead Principal Investigator, Brown University, Women & Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT01222364     History of Changes
Other Study ID Numbers: NICHD-NRN-0023
U10HD021364 ( U.S. NIH Grant/Contract )
U01HD021438 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
M01RR000080 ( U.S. NIH Grant/Contract )
M01RR008084 ( U.S. NIH Grant/Contract )
First Posted: October 18, 2010    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017

Keywords provided by NICHD Neonatal Research Network:
NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Very Low Birth Weight (VLBW)
Prematurity

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms