Milking the Umbilical Cord for Extreme Preterm Infants - Full Text View

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:

MedlinePlus related topics: Birth Weight Blood Transfusion and Donation Premature Babies

U.S. FDA Resources

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:	June 2016
Estimated Primary Completion Date:	June 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

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:

Hosono S, Mugishima H, Fujita H, Hosono A, Minato M, Okada T, Takahashi S, Harada K. Umbilical cord milking reduces the need for red cell transfusions and improves neonatal adaptation in infants born at less than 29 weeks' gestation: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2008 Jan;93(1):F14-9. Epub 2007 Jan 18.

Leavitt BG, Huff DL, Bell LA, Thurnau GR. Placental drainage of fetal blood at cesarean delivery and feto maternal transfusion: a randomized controlled trial. Obstet Gynecol. 2007 Sep;110(3):608-11.

Rabe H, Jewison A, Alvarez RF, Crook D, Stilton D, Bradley R, Holden D; Brighton Perinatal Study Group. Milking compared with delayed cord clamping to increase placental transfusion in preterm neonates: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):205-11.

Rabe H, Reynolds G, Diaz-Rossello J. Early versus delayed umbilical cord clamping in preterm infants. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD003248. Review.

Rabe H, Reynolds G, Diaz-Rossello J. A systematic review and meta-analysis of a brief delay in clamping the umbilical cord of preterm infants. Neonatology. 2008;93(2):138-44. Epub 2007 Sep 21. Review.

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:	May 17, 2013
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 May 23, 2013