Prematurity
Conditions
Keywords
neonate, umbilical cord, cord milking, prematurity
Brief summary
Anemia in preterm neonates is a significant problem encountered frequently in the neonatal intensive care unit. Most preterm neonates born at less than 33 weeks gestation will require at least one blood transfusion during their hospital course and many will require repeated transfusions. Blood transfusions, albeit necessary, carry increased risk of viral infections and transfusion reactions as well as increase the cost of healthcare. The umbilical cord and placenta harbor up to 40% of blood available during fetal life. The current standard of care is immediate umbilical cord clamping. The investigators are performing a randomized controlled trial comparing immediate cord clamping to milking the umbilical cord prior to clamping in neonate born preterm less than 33 weeks gestation. The investigators hypothesize that milking the umbilical cord will demonstrate the same benefits as delayed cord clamping, without delaying neonatal resuscitation.
Interventions
PROCEDUREMilking group
The umbilical cord will be milked toward the neonate four times prior to clamping the umbilical cord.
PROCEDUREImmediate cord clamping
The umbilical cord will be clamped and cut immediately after delivery of the neonate.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Preterm neonates delivered between 24 0/7 and 32 6/7 * Mother carrying a fetus between 24-32 6/7 weeks estimated gestational age * Written parental consent
Exclusion criteria
* Multiple gestation pregnancies (twins or higher order multiples) * Rh or other antibody sensitization * Hydrops fetalis * Known major congenital abnormality * Suspected abruptio placentae
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin during NICU course | within 24 hours of birth and through NICU stay |
Secondary
| Measure | Time frame |
|---|---|
| 1-min Apgar | at 1 minute of life |
| 5 min Apgar | at 5 minutes of life |
| Blood Sugar upon admission to NICU | within 1 hour of birth |
| Temperature on admission to NICU | within 1 hour of birth |
| Cord blood pH | within 1 hour of birth |
| Blood pressure upon admission to NICU | within 1 hour of birth |
| Number of volume challenges in first 24 hours of life | at 24 hours of birth |
| Days requiring ventilation | 2 months |
| Neonatal death | 6 months |
| Length of hospital stay | 6 months |
| Intraventricular hemorrhage | 6 months |
| Number and volume of blood transfusions | 10 units |
| duration of phototherapy | 1 month |
| Maximum serum bilirubin | 1 month |
Countries
United States
Outcome results
None listed