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
|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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- Infants enrolled [ Time Frame: 6 months ]Number of infants enrolled in the pilot within 6 months.
- Intention to treat [ Time Frame: 6 months ]Identify obstetricians willing to participate in randomizing subjects.
- Hematocrit level [ Time Frame: 4 hours of age ]
- Arterial blood pressure [ Time Frame: 12 hours of age ]
- Use of volume expansion or pressor therapy [ Time Frame: 24 hours of age ]
- Blood transfusions [ Time Frame: Until hospital discharge or 120 days of life ]
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
|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|
|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|