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Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy

NCT ID: NCT02287077

Last Updated: 2017-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Hypoxic Ischemic Encephalopathy Umbilical Cord Milking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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).

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Umbilical Cord Milking

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Umbilical cord stripping

Eligibility Criteria

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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
Maximum Eligible Age

1 Minute

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

UNKNOWN

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lata Mangeshkar Hospital and NKP Salve Institute of Medical Sciences

Nagpur, MS, India

Site Status

Countries

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India

Other Identifiers

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14D.522

Identifier Type: -

Identifier Source: org_study_id