Clinical trial NCT02092103: Delayed Clamping and Milking the Umbilical Cord in Preterm Infants
Official title: Delayed Clamping and Milking the Umbilical Cord Prior to Clamping in Preterm Infants and the Effect of Neonatal Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: Premature Birth
Umbilical Cord Clamping
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 282
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled trial that will compare the effects of delayed umbilical cord clamping to umbilical cord milking in preterm infants (less than 34 weeks gestation). The infants' hemoglobin and hematocrit levels in the Neonatal Intensive Care Unit (NICU) will be evaluated, as well as the rates of necrotizing enterocolitis, intraventricular hemorrhage, and blood transfusions. The hypothesis is that milking the umbilical cord prior to clamping is superior to simply delayed cord clamping, presumably providing an increased blood volume to the preterm neonate improving its outcomes.

Detailed description: The optimal timing for clamping the umbilical cord after birth in preterm infants has been a subject of controversy and debate for many years. It has been until recently the standard practice in ob/gyn to clamp the umbilical cord immediately post delivery to allow for immediate transition resuscitation of the neonate, especially in preterm infants. Due to the fact that optimal timing for cord clamping has yet to be definitively established in the preterm population, more information is needed. Immediate cord clamping, however, could preclude the infant from an extra boost in blood volume that may prove beneficial later in the newborn life. Directly comparing the recently recommended practice of delayed umbilical cord clamping to milking the umbilical cord prior to clamping has the potential to prove beneficial for the neonates in question, as well as change daily obstetrical practices. In this study all infants below 34 weeks will be randomized into one of two groups: delayed cord clamping and milking the umbilical cord prior to clamping. The decision was made not to include immediate cord clamping due to a recent American Congress of Obstetricians and Gynecologists (ACOG) recommendation that all preterm infants have their cord clamping be delayed. Their outcomes will be measured by serial hemoglobin and hematocrit levels while in the NICU, the incidence of necrotizing enterocolitis, incidence of intraventricular hemorrhage, and the need for neonatal blood transfusions.

Eligibility criteria: Inclusion Criteria:

* Admitted to Labor \& Delivery at Good Samaritan TriHealth Hospital in Cincinnati, Ohio with expected/possible preterm delivery between 23-34 weeks gestation
* Care provided by Good Samaritan TriHealth Hospital's Faculty Medical Center or Tri-State Maternal Fetal Medicine

Exclusion Criteria:

* Declined to participate
* Known congenital anomalies
* Precipitous delivery preventing completion of the protocol
* Placental abruption around the time of or as indication for delivery
* Mother has uterine rupture
* Non reassuring fetal heart tracing (FHT) immediately prior/leading to delivery
* Multiple gestation
* Parvo B19
* Infants known to be at risk of anemia due to isoimmunization (mother has red blood cell antibodies

Primary outcomes:
measure: Hemoglobin and Hematocrit values (H/H) in NICU
timeFrame: NICU admission to discharge, expected average of 50 days
Secondary outcomes:
measure: Neonatal transfusions
timeFrame: Birth to discharge, expected average of 50 days
measure: Necrotizing enterocolitis
timeFrame: Birth to discharge, expected average of 50 days
measure: Intraventricular hemorrhage
timeFrame: Birth to discharge, expected average of 50 days
Other outcomes:
measure: Length of stay
timeFrame: Birth to discharge, expected average of 50 days
measure: Survival to discharge
timeFrame: Birth to discharge, expected average of 50 days
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan TriHealth Hospital
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Kathleen Smith, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Committee Opinion No.543: Timing of umbilical cord clamping after birth. Obstet Gynecol. 2012 Dec;120(6):1522-6. doi: 10.1097/01.AOG.0000423817.47165.48.