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Tolerance of nHFPV Versus nCPAP in Neonatal Respiratory Distress

NCT02030691 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-07-23

No results posted yet for this study

Summary

Respiratory distress is the main cause of morbimortality in preterm and term neonates. In most of the case, these babies required the use of positive end expiratory pressure (PEEP) delivered by a non invasive device. Nasal continuous airway positive pressure (nCPAP) is widely used in neonatal intensive care unit. Nasal high frequency percussive ventilation (nHFPV) can be used as non invasive device to deliver PEEP, and improved lung clearance.

We hypothesized that nHFPV can be used to deliver PEEP in preterm and term newborn with respiratory distress with the same tolerance as nCPAP. To compare the tolerance of these devices we used cerebral tissue oxygenation (rSO2c) measured by near infrared spectroscopy (NIRS).

Conditions

  • Neonatal Respiratory Distress

Interventions

DEVICE

Nasal continuous airway positive pressure (nCPAP)

DEVICE

Nasal high frequency percussive ventilation (nHFPV)

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Laurent RENESME, MD · University Hospital Bordeaux, France

  • Antoine BENARD, MD · University Hospital Bordeaux, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
30 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • France

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 NCT02030691 on ClinicalTrials.gov