Milking the Umbilical Cord for Extreme Preterm Infants
Milking the umbilical cord from the placental end toward the infant has been shown to benefit preterm infants when compared to either clamping the umbilical cord immediately or waiting delaying the clamping of the cord. Delaying cord clamping for 30-120 seconds has been shown to improve heart and lung function, reduces the need for blood transfusion, and reduces the risk for brain bleeding seen in some preterm infants. Delaying the clamping of the umbilical cord, however in extremely premature infants is not considered safe, since it also delays the resuscitation that these infants need immediately after birth. Milking the umbilical cord is believed have similar benefits to delaying the clamping of the cord, but can be done much faster (seconds rather than minutes). In this study, the cord will milked three times over about 10-20 seconds and the infant will be passed to the awaiting newborn medical team for routine care. Participants of this study will be randomly assigned to one of two study groups: the first group will have the cord milking intervention and the second group will not have any intervention other than routine, immediate cord clamping with routine care of mother and infant. Data will be collected about the mother prior to delivery and data will also be collected about the baby using computerized health records. The data will look at short term changes in red blood cell volumes, the need for blood transfusions, and rates of known complications of prematurity, including longer term developmental complications at 18-24 months.
The hypothesis is that milking the umbilical cord before cutting the cord will lead to a higher hemoglobin concentration and decrease the need for blood transfusions in extremely preterm neonates compared to the current standard of immediately clamping the umbilical cord.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Milking the Umbilical Cord for Extreme Preterm Infants|
- To evaluate and compare hemoglobin and hematocrit concentrations in extremely low birth weight infants (ELVW) after cord milking intervention to ELBW infants receiving immediate cord clamping [ Time Frame: Within 4 hour of birth ] [ Designated as safety issue: No ]
- To evaluate and compare the incidence and numbers of blood transfusions after cord milking [ Time Frame: Prior to initial infant discharge ] [ Designated as safety issue: No ]
- To evaluate and compare blood pressure after intervention and need for support medications [ Time Frame: For first seven days of life ] [ Designated as safety issue: Yes ]
- To evaluate and compare the incidence of hyperbilirubinemia and length of phototherapy [ Time Frame: Three weeks ] [ Designated as safety issue: Yes ]Highest bilirubin or maximum at 120 hours of life, plus total days of phototherapy.
- To evaluate the incidence of complications of prematurity in the study and control groups [ Time Frame: Until 3 years corrected gestational age ] [ Designated as safety issue: Yes ]
- To evaluate long term outcomes of prematurity in both groups in a follow-up study [ Time Frame: Until 3 years corrected gestational age ] [ Designated as safety issue: No ]
- To compare the difference in hemoglobin and hematocrit from umbilical cord blood [ Time Frame: Within 4 hours of birth ] [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Cord Milking
Infant receiving cord milking intervention before umbilical cord clamped.
Procedure: Milking the umbilical cord before cord clamping
The procedure will involve positioning the neonate below the level of the placenta and milking approximately 20cm of umbilical cord three times over 10-20 seconds total from the placental end to the neonate. The cord will then be clamped and the neonate handed to the awaiting medical team for routine care of a premature infant.
No Intervention: Immediate Cord Clamping
Infant whose umbilical cord is immediately clamped after delivery.
Eligible infants include singleton infants born between 24 and 27 6/7 weeks gestation who do not have congenital anomalies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666847
|Contact: Justin Josephsen, MDfirstname.lastname@example.org|
|Contact: Mohamad Al-Hosni, MDemail@example.com|
|United States, Missouri|
|Saint Louis University, Division of Neonatology, SSM St. Mary's Health Center||Recruiting|
|Saint Louis, Missouri, United States, 63117|
|Principal Investigator: Justin Josephsen, MD|
|Saint Louis University, Division of Neonatology, SSM Cardinal Glennon Children's Medical Center||Recruiting|
|Saint Louis, Missouri, United States, 63104|
|Principal Investigator: Justin Josephsen, MD|
|Principal Investigator:||Justin B Josephsen, MD||St. Louis University|