Status:

COMPLETED

Monitoring Neonatal Resuscitation Trial

Lead Sponsor:

University of Pennsylvania

Collaborating Sponsors:

Leiden University Medical Center

Royal Women's Hospital in Melbourne, Australia

Conditions:

Resuscitation

Neonatal Prematurity

Eligibility:

All Genders

24-28 years

Phase:

NA

Brief Summary

This is a randomized trial to determine if a visible respiratory function monitor (RFM) displaying realtime measurements of delivered inflations improves clinical providers ability to perform positive...

Detailed Description

Recently, it has been demonstrated that the use of a respiratory function monitor (RFM) can guide PPV in the DR.(Wood, Schmolzer) In this study, the New Life Box, (Advanced Life Diagnostics, Weener, G...

Eligibility Criteria

Inclusion

  • Gestational age (GA) 24 - 27 6/7 weeks at birth, by best obstetrical
  • Receive positive pressure ventilation during delivery room resuscitation

Exclusion

  • Known major anomalies including that may affect measured cardiorespiratory parameters: congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease, pulmonary hypoplasia
  • RFM not available during resuscitation

Key Trial Info

Start Date :

February 20 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 20 2021

Estimated Enrollment :

288 Patients enrolled

Trial Details

Trial ID

NCT03256578

Start Date

February 20 2017

End Date

September 20 2021

Last Update

November 22 2021

Active Locations (1)

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1

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104