Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy

December 14, 2017 updated by: Thomas Jefferson University

A Randomized Controlled Trial of Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy

The objective of this pilot study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypoxic-ischemic encephalopathy (HIE) is a brain injury in neonates due to inadequate blood flow and oxygen delivery to the neonatal brain. Umbilical cord milking can potentially improve brain injury in neonates with HIE. The objective of this study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth. The investigators hypothesized that umbilical cord milking is feasible and safe in neonates who are depressed at birth. The investigators also hypothesized that umbilical cord milking will increase stem cells in neonatal blood circulation and improve short term outcomes in neonates with moderate and severe HIE.

Study Type

Interventional

Enrollment (Actual)

101

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

  • India
    • MS
      • Nagpur, MS, India, 440019
        • Lata Mangeshkar Hospital and NKP Salve Institute of Medical Sciences

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

No older than 1 minute (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Term and near term neonates (35 weeks and more)
  • Depressed at birth

Exclusion Criteria:

  • Congenital malformation of central nervous system
  • Chromosomal abnormalities
  • Major congenital malformations

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Immediate cord clamping
At birth, neonate will be held at the level of placenta and umbilical cord will be clamped immediately (standard of care for depressed neonates).
EXPERIMENTAL: Umbilical cord milking
At birth, neonate will be held below the level of placenta and umbilical cord will be milked 3 times before clamping the cord.
Procedure: Umbilical Cord Milking
At birth, neonate will be held below the level of placenta and umbilical cord will be milked 3 times before clamping the cord.
Other Names:
  • Umbilical cord stripping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of depressed neonates in whom umbilical cord milking was performed.
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
The number of neonates who are depressed at birth will be determined and the percentage of depressed neonates in whom UCM performed will be calculated. The investigators expect that more than 80% of neonates who qualify will receive UCM. The investigators will aslo compare resuscitation efforts (use of positive pressure ventilation, intubation, chest compression, medication and fluid boluses) and short term outcomes of resuscitation (5 minutes apgar, severity of HIE, blood gas at 1 hour) in neonates with and without UCM.
Participants will be followed for the duration of hospital stay, an expected average of 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of umbilical cord milking on stem and progenitor cells in peripheral blood of neonates.
Time Frame: 24 hours
Evaluate stem and progenitor cell count in peripheral blood of neonates with UCM and compare them with the control group (no UCM).
24 hours
The effect of umbilical cord milking on monocytes and lymphocytes in peripheral blood of neonates.
Time Frame: 24 hours
Evaluate absolute monocyte and lymphocyte count in peripheral blood of neonates with UCM and compare them with the control group (no UCM).
24 hours
The effect of umbilical cord milking on neurotrophic factors in peripheral blood of neonates.
Time Frame: 24 hours
Compare levels of neurotrophic factors in peripheral blood of neonates with and without UCM.
24 hours
Survival and short term outcomes in neonates with moderate and severe HIE
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
In infants with moderate or severe HIE, compare survival, neurological examination at discharge, and neuro-imaging studies in infants with and without UCM.
Participants will be followed for the duration of hospital stay, an expected average of 5 days

Collaborators and Investigators

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

Sponsor

Thomas Jefferson University

Collaborators

Lata Mangeshkar Hospital, NKP Salve Institute of Medical Sciences, Nagpur, India

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

December 1, 2014

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

October 31, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (ESTIMATE)

November 10, 2014

Study Record Updates

Last Update Posted (ACTUAL)

December 18, 2017

Last Update Submitted That Met QC Criteria

December 14, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14D.522

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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