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A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants

NCT03085329 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2017-03-22

No results posted yet for this study

Summary

This study is designed to test the hypothesis that among infants born at less than 30 weeks, weighing less than 1500 g at delivery, and receiving initial respiratory support non-invasively or on invasive respiratory support and meeting extubation criteria in the first 72 h of life, fewer neonates managed on Seattle--PAP will require endotracheal intubation and conventional mechanical ventilation (CMV) than will neonates managed from birth on bubble nasal continuous positive airway pressure (Bn-CPAP) using the Fischer- \& Paykel (FP) device. Neonates on nasal continuous positive airway pressure (CPAP) in the delivery room or who are stabilized on mechanical ventilation as their initial form of respiratory support and meet our criteria for extubation within 72 h of birth will be eligible for randomization and study.

The primary endpoint of this study is the cumulative incidence of respiratory failure requiring intubation that occurs in patients after randomization and before 36 weeks post menstrual age (PMA) or discharge, whichever comes first. Presently, the literature supports that this age group typically exhibits intubation rates of 50% or more, which is consistent with the data from the Nationwide Children's Hospital/Ohio State University (NCH/OSU) Neonatal Intensive Care Unit (NICU).

Conditions

  • Premature Birth

Interventions

DEVICE

Seattle-PAP

Seattle-PAP is a modified bubble CPAP device that has been given 510(k) clearance by the US FDA (K131502, October 11, 2013) and is thus recognized as substantially equivalent to other approved devices on the market. Results of a recently completed study in infants indicate that Bn-CPAP is associated with lower effort to breathe by spontaneously breathing premature infants.

DEVICE

Conventional bubble nasal CPAP

Infants enrolled in the study and randomized to this arm will be given respiratory support by bubble nasal CPAP using the Fisher \& Paykel bubbler device, which is the standard of care at Nationwide Children's.

Sponsors & Collaborators

  • Nationwide Children's Hospital

    collaborator OTHER

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Carl H Backes, Jr., MD · Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
30 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-10
Primary Completion
2018-10-31
Completion
2019-02-09
FDA Device
Yes

Countries

  • United States

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 NCT03085329 on ClinicalTrials.gov