Effects of Milking the Umbilical Cord on Systemic Blood Flow

October 6, 2017 updated by: Anup Katheria, M.D., Sharp HealthCare

A Randomized Controlled Trial of Umbilical Cord Milking Versus Immediate Cord Clamping on Systemic Blood Flow in Premature Infants

Premature babies are at risk for bleeding in their brains, which can result in developmental delays or other neurological problems such as cerebral palsy. Clamping the baby's umbilical cord immediately after birth is standard, but delaying this procedure allows more of the baby's blood to move from the placenta into the baby and prevents head bleeds. However, a delay in clamping the umbilical cord is not usually done in very premature babies, because it would delay their treatment and they could get cold. Milking the umbilical cord is another way to give premature babies more of their own blood while avoiding a delay in treatment. Umbilical cord milking has been shown to improve blood pressure, decrease the need for blood transfusions, and increase the amount of urine made in the first few days of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to determine whether umbilical cord milking improves blood flow in premature babies, and thereby reduce the occurrence of neurological problems. The investigators predict that the blood flow measured by ultrasounds of the heart will be higher in babies who receive umbilical cord milking compared to those whose cords are clamped immediately. Secondly, the investigators predict that cord milking will improve blood volume, blood pressure, and urine output, and delay the need for blood transfusions.

This will be the first study to look at the effect that umbilical cord milking has on important measures of blood flow, which can predict bleeding in the head and subsequent developmental problems in very premature babies.

Study Type

Interventional

Enrollment (Actual)

60

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
    • California
      • San Diego, California, United States, 92130
        • UCSD Medical 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • infants < 32 weeks gestation

Exclusion Criteria:

  • obstetrician's refusal to participate
  • multiple gestations (if Di-Mo placentation) surrogate delivery
  • parental desire for cord blood banking
  • major congenital anomalies
  • severe maternal illness
  • placental abruption or previa
  • ruptured uterus at delivery, or hemoperitoneum

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Umbilical Cord Milking
Umbilical Cord Milking involved milking the umbilical cord at birth.
Procedure: Umbilical Cord Milking
UCM will be performed by the obstetric team by having the delivering obstetrician hold the infant below the mother's introitus at vaginal delivery or below the level of the incision at cesarean section and having the assistant (the second obstetrician) milk about 20 cm of umbilical cord over 2 seconds and repeating two additional times.
Other Names:
  • stripping the umbilical cord
Active Comparator: Immediate Cord Clamping
Umbilical cord is clamped soon after birth without any milking of the cord.
Procedure: Immediate Cord Clamping
The umbilical cord will be clamped soon after birth without any milking of the umbilical cord.
Other Names:
  • routine clamping of the umbilical cord

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Superior Vena Cava Flow
Time Frame: 6 hours
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher SVC flow at 6 hours.
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: 6 hours of life
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher blood pressures at 6 hours of life.
6 hours of life
Neurodevelopmental Outcomes
Time Frame: between 18 and 36 months of life
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have improved neurodevelopmental outcomes. Neurodevelopmental follow-up data including cognitive, language, motor, social-emotional, and adaptive behavior composite scores from the Bayley Scales of Infant and Toddler Development (BSID-III) will be recorded when available. The presence of cerebral palsy, hearing and visual impairment will also be recorded when available.
between 18 and 36 months of life
number of blood transfusions
Time Frame: 36 weeks corrected gestational age
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have fewer blood transfusions at 36 weeks corrected gestational age.
36 weeks corrected gestational age
Superior Vena Cava Flow
Time Frame: 18 hours of life
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher SVC flow at 18 hours.
18 hours of life
Superior Vena Cava Flow
Time Frame: 30 hours of life
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher SVC flow at 30 hours.
30 hours of life
Blood Pressure
Time Frame: at 18 hours of life
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher blood pressures at 18 hours of life.
at 18 hours of life
Blood Pressure
Time Frame: 30 hours of life
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher blood pressures at 30 hours of life.
30 hours of life

Collaborators and Investigators

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

Sponsor

Sharp HealthCare

Investigators

  • Principal Investigator: Anup C Katheria, M.D., UCSD

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

April 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 3, 2011

First Submitted That Met QC Criteria

September 14, 2011

First Posted (Estimate)

September 15, 2011

Study Record Updates

Last Update Posted (Actual)

October 9, 2017

Last Update Submitted That Met QC Criteria

October 6, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CORDMILK

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.

Clinical Trials on Abnormal Vascular Flow

Clinical Trials on Umbilical Cord Milking

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe