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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Immediate clamping (\<5 seconds) of the umbilical cord after delivery.
Clamping of the umbilical cord at 30-45 seconds after birth.
University of Alabama
Birmingham, Alabama, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Infants enrolled
Number of infants enrolled in the pilot within 6 months.
Time frame: 6 months
Intention to treat
Identify obstetricians willing to participate in randomizing subjects.
Time frame: 6 months
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
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