Milking the Umbilical Cord for Extreme Preterm Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 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: April 4, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Infant, Premature
Procedure: Milking the umbilical cord before cord clamping

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by St. Louis University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
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)
Arms Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666847

Contacts
Contact: Justin Josephsen, MD 314-577-5642 jjosephs@slu.edu
Contact: Mohamad Al-Hosni, MD 314-577-5642 alhosnim@slu.edu

Locations
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         
Sponsors and Collaborators
St. Louis University
Investigators
Principal Investigator: Justin B Josephsen, MD St. Louis University
  More Information

Publications:
Responsible Party: St. Louis University
ClinicalTrials.gov Identifier: NCT01666847     History of Changes
Other Study ID Numbers: 21429
Study First Received: August 14, 2012
Last Updated: April 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Louis University:
Umbilical Cord Milking
Extremely Low Birth Weight Infant (ELBW)

ClinicalTrials.gov processed this record on September 18, 2014