MedTrace Logo

Monitoring Neonatal Resuscitation Trial

NCT03256578 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2021-11-22

Study results available
· View outcomes & findings →

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.

Conditions

  • Resuscitation
  • Neonatal Prematurity
  • Positive-Pressure Respiration

Interventions

DEVICE

New Life Box Respiratory Function Monitor

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.

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • Royal Women's Hospital in Melbourne, Australia

    collaborator UNKNOWN

  • Maternal & Children's University Hospital, Valencia, Spain

    collaborator OTHER

  • Vittore Buzzi Children's Hospital

    collaborator OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Arjan te Pas, MD · Leiden University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
24 Weeks
Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-20
Primary Completion
2019-05-17
Completion
2021-09-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03256578 on ClinicalTrials.gov