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Milking the Umbilical Cord for Extreme Preterm Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by St. Louis University
Sponsor:
Information provided by (Responsible Party):
St. Louis University
ClinicalTrials.gov Identifier:
NCT01666847
First received: August 14, 2012
Last updated: November 17, 2014
Last verified: November 2014

August 14, 2012
November 17, 2014
October 2012
March 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01666847 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 hyperbilirubenemia 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 ]
Not Provided
Not Provided
 
Milking the Umbilical Cord for Extreme Preterm Infants
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.

Eligible infants include singleton infants born between 24 and 27 6/7 weeks gestation who do not have congenital anomalies.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infant, Extremely Premature
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.
  • Experimental: Cord Milking
    Infant receiving cord milking intervention before umbilical cord clamped.
    Intervention: Procedure: Milking the umbilical cord before cord clamping
  • No Intervention: Immediate Cord Clamping
    Infant whose umbilical cord is immediately clamped after delivery.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
March 2017
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • pregnant women/child pairs with infants born at an estimated gestation age between 24 0/7 and 27 6/7 weeks based on best estimate made by last menstrual period or ultrasound
  • informed consent obtained by the pregnant women prior to delivery of the infant.

Exclusion Criteria:

  • pregnancy with a multiple gestation
  • infants with pre- or postnatally diagnosed major congenital anomalies or probable chromosomal abnormalities
  • infants with hydrops fetalis
Both
Not Provided
Yes
Contact: Justin Josephsen, MD 314-577-5642 jjosephs@slu.edu
Contact: Mohamad Al-Hosni, MD 314-577-5642 alhosnim@slu.edu
United States
 
NCT01666847
21429
Yes
St. Louis University
St. Louis University
Not Provided
Principal Investigator: Justin B Josephsen, MD St. Louis University
St. Louis University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP