Milking the Umbilical Cord for Extreme Preterm Infants

NCT01666847 | Completed DMC

• 1 other identifier: 21429
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Infant, Extremely Premature

Keywords

Umbilical Cord Milking; Extremely Low Birth Weight Infant (ELBW)

Outcome Measures

Primary Outcomes (2)

• 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

  Within 4 hour of birth

• To evaluate and compare the incidence and numbers of blood transfusions after cord milking

  Prior to initial infant discharge

Secondary Outcomes (5)

• To evaluate and compare blood pressure after intervention and need for support medications

  For first seven days of life

• To evaluate and compare the incidence of hyperbilirubinemia and length of phototherapy

  Three weeks

• To evaluate the incidence of complications of prematurity in the study and control groups

  Until 3 years corrected gestational age

• To evaluate long term outcomes of prematurity in both groups in a follow-up study

  Until 3 years corrected gestational age

• To compare the difference in hemoglobin and hematocrit from umbilical cord blood

  Within 4 hours of birth

Study Arms (2)

Cord Milking

EXPERIMENTAL

Infant receiving cord milking intervention before umbilical cord clamped.

Procedure: Milking the umbilical cord before cord clamping

Immediate Cord Clamping

NO INTERVENTION

Infant whose umbilical cord is immediately clamped after delivery.

Interventions

Milking the umbilical cord before cord clamping PROCEDURE

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.

Cord Milking

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• pregnancy with a multiple gestation
• infants with pre- or postnatally diagnosed major congenital anomalies or probable chromosomal abnormalities
• infants with hydrops fetalis

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (2)

Saint Louis University, Division of Neonatology, SSM Cardinal Glennon Children's Medical Center

St Louis, Missouri, 63104, United States

Location

Saint Louis University, Division of Neonatology, SSM St. Mary's Health Center

St Louis, Missouri, 63117, United States

Location

Related Publications (5)

• 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. doi: 10.1136/adc.2006.108902. Epub 2007 Jan 18.

  PMID: 17234653 BACKGROUND

• 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. doi: 10.1097/01.AOG.0000277262.80793.0d.

  PMID: 17766607 BACKGROUND

• Rabe H, Jewison A, Fernandez Alvarez R, 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):205-211. doi: 10.1097/AOG.0b013e3181fe46ff.

  PMID: 21252731 BACKGROUND

• 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. doi: 10.1002/14651858.CD003248.pub2.

  PMID: 15495045 BACKGROUND

• 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. doi: 10.1159/000108764. Epub 2007 Sep 21.

  PMID: 17890882 BACKGROUND

Study Officials

• Justin B Josephsen, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 16, 2012
• Study Start: October 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: July 1, 2017
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

US (2)