NCT02030691

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2016

Completed
Last Updated

May 28, 2026

Status Verified

July 1, 2017

Enrollment Period

2.5 years

First QC Date

January 7, 2014

Last Update Submit

May 27, 2026

Conditions

Neonatal Respiratory Distress

Keywords

Neonatal respiratory distressnHFPVnCPAPcerebral tissue oxygenationNIRS

Outcome Measures

Primary Outcomes (1)

  • Measurement of cerebral tissue oxygenation (rSO2c) by near infrared spectroscopy (NIRS). We compared the mean of the variation of rSO2c during the last 5 minutes for each device (nHFPV and nCPAP).

    30 minutes after the inclusion

Secondary Outcomes (1)

  • Measurement of transcutaneous capnia and oxygen saturation; variation of heart rate, breath rate and blood pressure; ventilators' setting (PEEP, FiO2).

    30 minutes after the inclusion

Study Arms (2)

nCPAP - nHFPV

EXPERIMENTAL

Eligible patient received after randomization nCPAP or nHFPV for 15 minutes then after the 15 minutes, they received the seconde non invasive device for 15 minutes. Study end 30 minutes after randomization or before if mechanical ventilation is required.

Device: Nasal continuous airway positive pressure (nCPAP)Device: Nasal high frequency percussive ventilation (nHFPV)

nHFPV - nCPAP

EXPERIMENTAL

Eligible patient received after randomization nCPAP or nHFPV for 15 minutes then after the 15 minutes, they received the seconde non invasive device for 15 minutes. Study end 30 minutes after randomization or before if mechanical ventilation is required.

Device: Nasal continuous airway positive pressure (nCPAP)Device: Nasal high frequency percussive ventilation (nHFPV)

Interventions

Nasal high frequency percussive ventilation (nHFPV)DEVICE
nCPAP - nHFPVnHFPV - nCPAP
Nasal continuous airway positive pressure (nCPAP)DEVICE
nCPAP - nHFPVnHFPV - nCPAP

Eligibility Criteria

AgeUp to 30 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Inborn neonate.
  • Delivered by vaginal delivery or caesarean section.
  • Gestational age greater than or equal to 33 weeks of gestation.
  • Birth weight \> 1kg.
  • Respiratory distress with a Silverman score greater than or equal to 4 after 10 minutes of life.
  • Signed parental informed consent.

You may not qualify if:

  • Meconium aspiration syndrome.
  • Congenital anomalies such as heart anomalies, congenital cystic adenomatoid malformation, diaphragmatic hernia…

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Néonatalogie - Maternité - Hôpital Pellegrin

Bordeaux, Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Laurent RENESME, MD

    University Hospital Bordeaux, France

    PRINCIPAL INVESTIGATOR

  • Antoine BENARD, MD

    University Hospital Bordeaux, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 8, 2014

Study Start

May 1, 2014

Primary Completion

November 7, 2016

Study Completion

November 7, 2016

Last Updated

May 28, 2026

Record last verified: 2017-07

Locations

FR(1)