Clinical trial NCT01819532: Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks
Official title: Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants <33 Weeks: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prematurity
Keywords: neonate
umbilical cord
cord milking
prematurity
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-03-27
Enrollment: 22
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin during NICU course
timeFrame: within 24 hours of birth and through NICU stay
Secondary outcomes:
measure: 1-min Apgar
timeFrame: at 1 minute of life
measure: 5 min Apgar
timeFrame: at 5 minutes of life
measure: Blood Sugar upon admission to NICU
timeFrame: within 1 hour of birth
measure: Temperature on admission to NICU
timeFrame: within 1 hour of birth
measure: Cord blood pH
timeFrame: within 1 hour of birth
measure: Blood pressure upon admission to NICU
timeFrame: within 1 hour of birth
measure: Number of volume challenges in first 24 hours of life
timeFrame: at 24 hours of birth
measure: Days requiring ventilation
timeFrame: 2 months
measure: Neonatal death
timeFrame: 6 months
measure: Length of hospital stay
timeFrame: 6 months
measure: Intraventricular hemorrhage
timeFrame: 6 months
measure: Number and volume of blood transfusions
timeFrame: 10 units
measure: duration of phototherapy
timeFrame: 1 month
measure: Maximum serum bilirubin
timeFrame: 1 month
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Jessica Bienstock, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: