The Effect of Cord Milking on Hemodynamic Status of Preterm Infants

March 7, 2017 updated by: Walid El-Naggar

The Effect of Umbilical Cord Milking on Hemodynamic Status of Preterm Infants: a Randomized Controlled Trial

Very preterm babies frequently develop problems with their blood circulation during the first few days after birth. These circulation problems could affect the oxygen and blood flow to their brain and lead to effects such as bleeding in the head or delayed developmental milestones later in life. Currently the care for such problems may include transfusion of intravenous fluids or blood to the baby and/or giving the baby medications that can help circulation.

The current practice at the delivery of these babies is to immediately clamp their umbilical cords after birth. Recent research studies have shown that giving more of the baby's own blood to them at birth by delayed cord clamping (waiting for clamping the cord for about 30-90 seconds) or by milking the cord, may reduce the number of blood transfusions that these babies may need later on. It may also improve their initial blood pressure and reduce the chances of bleeding in their heads.

More research is needed to prove if either delayed cord clamping or milking the cord at birth will be better in terms of improving these babies' health.

The aim of this study is to find out if adding some blood to these babies' circulation, through milking the cord at birth, could prevent or reduce the possible problems with blood circulation and the reduced blood flow to the brain that some of these babies may have after birth.

The investigators will also investigate if milking the cord at birth could improve their long-term developmental outcome.

Hypothesis: In preterm infants less than 31 weeks' gestation, milking the umbilical cord 3 times prior to clamping, compared to immediate clamping after birth will improve systemic blood flow (as assessed by improving superior vena cava flow measured by heart ultrasound in the first 24 hours after birth)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Eligible mothers will be randomized prior to delivery once preterm labour is established (cervical dilatation > 4cm and preterm birth is considered inevitable or delivery is indicated for maternal or fetal indications) to either milking of the umbilical cord of their infants (intervention group) or to clamp the cord as per standard practice (currently it is the immediate cord clamping) after birth (control group). Randomization will be done in variable block sizes and will be concealed by using opaque envelopes prepared ahead of time from a randomization table. Envelopes will be opened before the time of delivery.

Study Type

Interventional

Enrollment (Actual)

73

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

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • IWK Health Centre

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

10 months to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:Preterm infants < 31 weeks' gestation if their mothers fulfill the following inclusion criteria:

  1. admitted to the hospital for at least 2 hours before delivery in preterm labor (cervical dilatation >2 cm or having premature rupture of membranes) or if a decision to induce labour has been made by treating physician for a maternal or fetal indications).
  2. at 24+0 weeks - 30+6/7 weeks gestation (by best estimate based on date of last menstrual period or early ultrasound)

Exclusion Criteria:

  1. monochorionic twin or any higher order multiple pregnancy
  2. major fetal congenital or chromosomal anomalies
  3. significant placental abruption
  4. fetal anemia/transfusion
  5. Rh isoimmunization
  6. intent to withhold or withdraw treatment of the infant

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: immediate umbilical cord clamping
The control group will receive immediate cord clamping at birth which is the standard of care in our institution
Procedure: immediate umbilical cord clamping
immediate cord clamping without milking as per standard practice
Other Names:
  • standard practice-cord clamping
Experimental: Milking the umbilical cord at birth
Infants in the cord-milked group will be placed at or below the level of the placenta, and about 20 cm of the umbilical cord (or the length of cord that is accessible if less than 20 cm) will be vigorously milked towards the umbilicus three times before clamping the cord.
Procedure: Milking the umbilical cord at birth
Infants in the cord-milked group will be placed at or below the level of the placenta, and about 20 cm of the umbilical cord (or the length of cord that is accessible if less than 20 cm) will be vigorously milked towards the umbilicus three times before clamping the cord
Other Names:
  • Transfusion of blood from umbilical cord to the baby

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 4-6 hours after birth.
Time Frame: at 4-6 hours of age
at 4-6 hours of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
low SVC flow (< 40 ml/kg/min), as assessed by echocardiography
Time Frame: at 4-6 and 10-12 hours of age
at 4-6 and 10-12 hours of age
Hypotension
Time Frame: during the first 48 hours of life
Hypotension is defiined as mean blood pressure < corresponding gestational age number for > 30 minutes
during the first 48 hours of life
Hyperbilirubinemia and peak bilirubin level recording
Time Frame: during first 2 weeks of age
Hyperbilirubinemia requiring phototherapy (as per routine unit practice)
during first 2 weeks of age
Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 10-12 hours after birth.
Time Frame: at 10-12 hours of age
at 10-12 hours of age
Number of blood transfusions during hospital stay
Time Frame: at 40 weeks of corrected gestational age
at 40 weeks of corrected gestational age
Intraventricular hemorrhage (IVH)
Time Frame: during first 2 weeks of life
Intraventricular hemorrhage (IVH) as diagnosed by standard-practice cranial ultrasounds
during first 2 weeks of life
Neurodevelopmental outcome
Time Frame: At 36 months of age
At 36 months of age

Collaborators and Investigators

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

Sponsor

Walid El-Naggar

Investigators

  • Principal Investigator: Walid I El-Naggar, MD, IWK Health Centre- Dalhousie 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

November 1, 2011

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

November 22, 2011

First Submitted That Met QC Criteria

December 5, 2011

First Posted (Estimate)

December 7, 2011

Study Record Updates

Last Update Posted (Actual)

March 9, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1002554

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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