CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 288 enrolled
Drug / intervention
New Life Box Respiratory Function Monitordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03256578
NCT03256578N/ACompleted
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A Multi-center Randomized Controlled Trial of Respiratory Function Monitoring During Stabilization of Preterm Infants at Birth

University of Pennsylvania·interventional·Posted Aug 22, 2017·Updated Nov 22, 2021

In Brief

A clinical study evaluating New Life Box Respiratory Function Monitor for Resuscitation and 2 related conditions. Completed, enrolled 288 participants across 1 site.

Detailed 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 pressure ventilation (PPV) within a pre-defined target tidal volume in preterm infants after birth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsResuscitation, Neonatal Prematurity, Positive-Pressure Respiration
CountriesUnited States
CollaboratorsLeiden University Medical Center, Royal Women's Hospital in Melbourne, Australia, Maternal & Children's University Hospital, Valencia, Spain, Vittore Buzzi Children's Hospital, Karolinska University Hospital

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 22, 2017
Enrollment StartFeb 20, 2017
Primary CompletionMay 17, 2019
Study CompletionSep 20, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.9 years ago

Interventions

New Life Box Respiratory Function Monitordevice

The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.