Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants <33 Weeks: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Johns Hopkins University
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Hemoglobin during NICU course
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to 50 Years (Child, Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Immediate umbilical cord clamping
The umbilical cord will be clamped immediately after delivery.
Intervention: Immediate cord clamping (Procedure)
Cord milking group
The umbilical cord will be "milked" in direction towards neonate 4 times over the course of 10 minutes.
Intervention: Milking group (Procedure)
Outcomes
Primary Outcomes
Hemoglobin during NICU course
Time Frame: within 24 hours of birth and through NICU stay
Secondary Outcomes
- Maximum serum bilirubin(1 month)
- Blood Sugar upon admission to NICU(within 1 hour of birth)
- Number of volume challenges in first 24 hours of life(at 24 hours of birth)
- 1-min Apgar(at 1 minute of life)
- 5 min Apgar(at 5 minutes of life)
- 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)
- 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)