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Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy

Primary Purpose

Hypoxic Ischemic Encephalopathy, Umbilical Cord Milking

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Umbilical Cord Milking
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypoxic Ischemic Encephalopathy

Eligibility Criteria

undefined - 1 Minute (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lata Mangeshkar Hospital and NKP Salve Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Immediate cord clamping

Umbilical cord milking

Arm Description

At birth, neonate will be held at the level of placenta and umbilical cord will be clamped immediately (standard of care for depressed neonates).

At birth, neonate will be held below the level of placenta and umbilical cord will be milked 3 times before clamping the cord.

Outcomes

Primary Outcome Measures

The number of depressed neonates in whom umbilical cord milking was performed.
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.

Secondary Outcome Measures

The effect of umbilical cord milking on stem and progenitor cells in peripheral blood of neonates.
Evaluate stem and progenitor cell count in peripheral blood of neonates with UCM and compare them with the control group (no UCM).
The effect of umbilical cord milking on monocytes and lymphocytes in peripheral blood of neonates.
Evaluate absolute monocyte and lymphocyte count in peripheral blood of neonates with UCM and compare them with the control group (no UCM).
The effect of umbilical cord milking on neurotrophic factors in peripheral blood of neonates.
Compare levels of neurotrophic factors in peripheral blood of neonates with and without UCM.
Survival and short term outcomes in neonates with moderate and severe HIE
In infants with moderate or severe HIE, compare survival, neurological examination at discharge, and neuro-imaging studies in infants with and without UCM.

Full Information

First Posted
October 31, 2014
Last Updated
December 14, 2017
Sponsor
Thomas Jefferson University
Collaborators
Lata Mangeshkar Hospital, NKP Salve Institute of Medical Sciences, Nagpur, India
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1. Study Identification

Unique Protocol Identification Number
NCT02287077
Brief Title
Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy
Official Title
A Randomized Controlled Trial of Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
Collaborators
Lata Mangeshkar Hospital, NKP Salve Institute of Medical Sciences, Nagpur, India

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic Ischemic Encephalopathy, Umbilical Cord Milking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate cord clamping
Arm Type
No Intervention
Arm Description
At birth, neonate will be held at the level of placenta and umbilical cord will be clamped immediately (standard of care for depressed neonates).
Arm Title
Umbilical cord milking
Arm Type
Experimental
Arm Description
At birth, neonate will be held below the level of placenta and umbilical cord will be milked 3 times before clamping the cord.
Intervention Type
Procedure
Intervention Name(s)
Umbilical Cord Milking
Other Intervention Name(s)
Umbilical cord stripping
Intervention Description
At birth, neonate will be held below the level of placenta and umbilical cord will be milked 3 times before clamping the cord.
Primary Outcome Measure Information:
Title
The number of depressed neonates in whom umbilical cord milking was performed.
Description
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.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary Outcome Measure Information:
Title
The effect of umbilical cord milking on stem and progenitor cells in peripheral blood of neonates.
Description
Evaluate stem and progenitor cell count in peripheral blood of neonates with UCM and compare them with the control group (no UCM).
Time Frame
24 hours
Title
The effect of umbilical cord milking on monocytes and lymphocytes in peripheral blood of neonates.
Description
Evaluate absolute monocyte and lymphocyte count in peripheral blood of neonates with UCM and compare them with the control group (no UCM).
Time Frame
24 hours
Title
The effect of umbilical cord milking on neurotrophic factors in peripheral blood of neonates.
Description
Compare levels of neurotrophic factors in peripheral blood of neonates with and without UCM.
Time Frame
24 hours
Title
Survival and short term outcomes in neonates with moderate and severe HIE
Description
In infants with moderate or severe HIE, compare survival, neurological examination at discharge, and neuro-imaging studies in infants with and without UCM.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Minute
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Lata Mangeshkar Hospital and NKP Salve Institute of Medical Sciences
City
Nagpur
State/Province
MS
ZIP/Postal Code
440019
Country
India

12. IPD Sharing Statement

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Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy

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