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Role of Umbilical Cord Milking in the Management of Hypoxic-ischemic Encephalopathy in Neonates

NCT03123081 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2021-03-02

No results posted yet for this study

Summary

The purpose of this study is to investigate the efficacy and safety of umbilical cord milking in depressed neonates at birth for prevention of hypoxic ischemic encephalopathy.

Conditions

  • Hypoxic-Ischemic Encephalopathy

Interventions

PROCEDURE

Umbilical Cord Milking

At birth the cord of a depressed newborn is clamped immediately and cut 30 cm from the umbilicus. After completion of initial steps, if required, positive pressure ventilation (PPV) is given for 30 seconds, along with UCM. The cord is untwisted and held in a vertical position. It is milked 3 times towards the baby at a speed of 10 cm/s and then clamped 3 cm from the umbilicus. After completion of PPV along with UCM, if the baby requires further resuscitation, the NRP 2015 guidelines will be followed. Depressed newborns who respond to initial steps of resuscitation with normal breathing and heart rate of 100 bpm or higher, will receive UCM after this.

Sponsors & Collaborators

  • Jubilee Mission Medical College and Research Institute

    lead OTHER

Principal Investigators

  • Manoj Varanattu, MD · Jubilee Mission Medical College and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
24 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2021-12-31
Completion
2022-07-01

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03123081 on ClinicalTrials.gov