Milking the Umbilical Cord for Extreme Preterm Infants

August 11, 2019 updated by: Justin Josephsen M.D., St. Louis University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • Saint Louis University, Division of Neonatology, SSM Cardinal Glennon Children's Medical Center
      • Saint Louis, Missouri, United States, 63117
        • Saint Louis University, Division of Neonatology, SSM St. Mary's Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Within 4 hour of birth
To evaluate and compare the incidence and numbers of blood transfusions after cord milking
Time Frame: Prior to initial infant discharge
Prior to initial infant discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate and compare blood pressure after intervention and need for support medications
Time Frame: For first seven days of life
For first seven days of life
To evaluate and compare the incidence of hyperbilirubinemia and length of phototherapy
Time Frame: Three weeks
Highest bilirubin or maximum at 120 hours of life, plus total days of phototherapy.
Three weeks
To evaluate the incidence of complications of prematurity in the study and control groups
Time Frame: Until 3 years corrected gestational age
Until 3 years corrected gestational age
To evaluate long term outcomes of prematurity in both groups in a follow-up study
Time Frame: Until 3 years corrected gestational age
Until 3 years corrected gestational age
To compare the difference in hemoglobin and hematocrit from umbilical cord blood
Time Frame: Within 4 hours of birth
Within 4 hours of birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Louis University

Investigators

  • Principal Investigator: Justin B Josephsen, MD, St. Louis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

July 1, 2017

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

August 14, 2012

First Posted (ESTIMATE)

August 16, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 11, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21429

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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