Infant, Low Birth Weight, Infant, Newborn, Infant, Premature, Infant, Small for Gestational Age
Conditions
Keywords
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity
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.
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.
Interventions
PROCEDUREStandard Cord Clamping
Immediate clamping (\<5 seconds) of the umbilical cord after delivery.
PROCEDUREDelayed Cord Clamping
Clamping of the umbilical cord at 30-45 seconds after birth.
Sponsors
NICHD Neonatal Research Network
National Center for Research Resources (NCRR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 1 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infants enrolled | 6 months | Number of infants enrolled in the pilot within 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intention to treat | 6 months | Identify obstetricians willing to participate in randomizing subjects. |
| Hematocrit level | 4 hours of age | — |
| Arterial blood pressure | 12 hours of age | — |
| Use of volume expansion or pressor therapy | 24 hours of age | — |
| Blood transfusions | Until hospital discharge or 120 days of life | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWilliam Oh, MD
Brown University, Women & Infants Hospital of Rhode Island
PRINCIPAL_INVESTIGATORAvroy A. Fanaroff, MD
Case Western Reserve University, Rainbow Babies and Children's Hospital
PRINCIPAL_INVESTIGATOREdward F. Donovan, MD
Children's Hospital Medical Center, Cincinnati
PRINCIPAL_INVESTIGATORWaldemar A. Carlo, MD
University of Alabama at Birmingham
Outcome results
None listed