Delayed Clamping and Milking the Umbilical Cord in Preterm Infants
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.
Infant, Extremely Premature
Procedure: Cord Milking
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Delayed Clamping and Milking the Umbilical Cord Prior to Clamping in Preterm Infants and the Effect of Neonatal Outcomes|
- Hemoglobin and Hematocrit values (H/H) in NICU [ Time Frame: NICU admission to discharge, expected average of 50 days ] [ Designated as safety issue: No ]All H/H values in the neonatal intensive care unit (NICU) will be recorded.
- Neonatal transfusions [ Time Frame: Birth to discharge, expected average of 50 days ] [ Designated as safety issue: No ]The incidence of transfusions between the two groups will be compared.
- Necrotizing enterocolitis [ Time Frame: Birth to discharge, expected average of 50 days ] [ Designated as safety issue: No ]The incidence of necrotizing enterocolitis between the two groups will be compared.
- Intraventricular hemorrhage [ Time Frame: Birth to discharge, expected average of 50 days ] [ Designated as safety issue: No ]The incidence of intraventricular hemorrhage between the two groups will be compared.
- Length of stay [ Time Frame: Birth to discharge, expected average of 50 days ] [ Designated as safety issue: No ]The length of NICU stay between the two arms will be compared.
- Survival to discharge [ Time Frame: Birth to discharge, expected average of 50 days ] [ Designated as safety issue: No ]The rate of infant survival until discharge will be recorded for both groups.
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
No Intervention: Delayed Clamping
The American Congress of Obstetricians and Gynecologists (ACOG) recommends delayed cord clamping for preterm infants. Infants randomized to this group will follow the protocol below:
Experimental: Cord Milking
Infants randomized to the cord milking group will follow the protocol below:
Procedure: Cord Milking
See description in cord milking arm.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02092103
|Contact: Kathleen Smith, MD PhDfirstname.lastname@example.org|
|Contact: Stephanie Manolis, DOemail@example.com|
|United States, Ohio|
|Good Samaritan TriHealth Hospital||Recruiting|
|Cincinnati, Ohio, United States, 45220|
|Contact: Michaela Eschenbacher, MPH 513-862-2341 firstname.lastname@example.org|
|Principal Investigator:||Kathleen Smith, MD PhD||TriHealth Inc.|