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Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome

Primary Purpose

Prematurity, Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
nasal intermittent positive pressure ventilation
Sponsored by
Instituto Materno Infantil Prof. Fernando Figueira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prematurity focused on measuring non invasive ventilation, mechanical ventilation, pulmonary morbidity, preterm infant, Respiratory distress syndrome, nasal intermittent positive pressure, nasal continuous positive pressure, bronchopulmonary dysplasia

Eligibility Criteria

1 Day - 1 Day (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • preterm infants with RDS
  • assigned to non invasive ventilation

Exclusion Criteria:

  • preterm on endotracheal ventilation
  • severe congenital pulmonary or cardiovascular malformation

Sites / Locations

  • Maternal Infant Institute Prof Fernando Figueira
  • Instituto materno Infantil Fernando Figueira

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

NCPAP

NIPPV

Arm Description

preterm infants with nasal positive pressure ventilation as a primary mode of respiratory support in preterm infants with respiratory distress syndrome will be compared to preterm infants with nasal intermittent positive pressure ventilation

preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support in preterm infants with respiratory distress syndrome

Outcomes

Primary Outcome Measures

Need for Endotracheal Ventilation in the First 72 hs of Life
number of participants that needed endotracheal ventilation (failed non invasive ventilation) in the first 72 hours of life
Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP)
The primary outcome of the study was the need for intubation within the first 72 hours (h) of life.The need for intubation was made by the attending neonatologist, according to the strict protocol of intubation for ventilation, used in the neonatal Unit

Secondary Outcome Measures

Bronchopulmonary Dysplasia
The incidence of bronchopulmonary dysplasia was calculated based on the number of infants surviving to 36 weeks postmenstrual age and diagnosed with bronchopulmonary dysplasia, according to the definiton of bronchopulmonary dysplasia currently used in the neonatal Unit.

Full Information

First Posted
January 12, 2009
Last Updated
March 3, 2013
Sponsor
Instituto Materno Infantil Prof. Fernando Figueira
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1. Study Identification

Unique Protocol Identification Number
NCT00821119
Brief Title
Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome
Official Title
A Randomized Controlled Trial of Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Pressure as a Primary Mode for Respiratory Distress Syndrome in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Materno Infantil Prof. Fernando Figueira

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the hypothesis that nasal intermittent positive pressure(NIPP), used as a primary mode of ventilation in preterm infants with RDS, will decrease the need for conventional endotracheal ventilation when compared to nasal continuous positive airway pressure.(NCPAP)
Detailed Description
Respiratory distress syndrome(RDS) and its sequelae, bronchopulmonary dysplasia(BPD) are complications of prematurity.The pathogenesis of BPD is multifactorial and one of the most important risk factors is the ventilator-induced lung injury caused by invasive respiratory support. The two modes of non-invasive ventilation, NIPP and specially NCPAP, have been used frequently in the respiratory care of preterm infants in neonatal units.NCPAP is currently a common practice for the treatment of RDS . NIPP has been found to be more effective than NCPAP in apnea of prematurity and immediately after extubation in preterm infants,decreasing the need of endotracheal ventilation. Alternative techniques of non-invasive ventilation has been suggested in some studies to decrease respiratory morbidities associated with prematurity.This non-invasive approach could be used initially as a primary mode of ventilation for infants with RDS in a effort to decrease lung injury and BPD.Studies are needed to compare the effectiveness of these therapies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Respiratory Distress Syndrome
Keywords
non invasive ventilation, mechanical ventilation, pulmonary morbidity, preterm infant, Respiratory distress syndrome, nasal intermittent positive pressure, nasal continuous positive pressure, bronchopulmonary dysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NCPAP
Arm Type
Active Comparator
Arm Description
preterm infants with nasal positive pressure ventilation as a primary mode of respiratory support in preterm infants with respiratory distress syndrome will be compared to preterm infants with nasal intermittent positive pressure ventilation
Arm Title
NIPPV
Arm Type
Experimental
Arm Description
preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support in preterm infants with respiratory distress syndrome
Intervention Type
Device
Intervention Name(s)
nasal intermittent positive pressure ventilation
Other Intervention Name(s)
NIPPV
Intervention Description
Nasal intermittent positive airway pressure will be compared are the nasal continuous positive pressure as an initial ventilatory mode in preterm infants with respiratory distress syndrome
Primary Outcome Measure Information:
Title
Need for Endotracheal Ventilation in the First 72 hs of Life
Description
number of participants that needed endotracheal ventilation (failed non invasive ventilation) in the first 72 hours of life
Time Frame
first 72 hs of life
Title
Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP)
Description
The primary outcome of the study was the need for intubation within the first 72 hours (h) of life.The need for intubation was made by the attending neonatologist, according to the strict protocol of intubation for ventilation, used in the neonatal Unit
Time Frame
first 3 days of life(72hours)
Secondary Outcome Measure Information:
Title
Bronchopulmonary Dysplasia
Description
The incidence of bronchopulmonary dysplasia was calculated based on the number of infants surviving to 36 weeks postmenstrual age and diagnosed with bronchopulmonary dysplasia, according to the definiton of bronchopulmonary dysplasia currently used in the neonatal Unit.
Time Frame
at 36 weeks gestational age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: preterm infants with RDS assigned to non invasive ventilation Exclusion Criteria: preterm on endotracheal ventilation severe congenital pulmonary or cardiovascular malformation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joao Guilherme B Alves, PhD
Organizational Affiliation
Instituto Materno Infantil Prof. Fernando Figueira
Official's Role
Study Director
Facility Information:
Facility Name
Maternal Infant Institute Prof Fernando Figueira
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50.070-550
Country
Brazil
Facility Name
Instituto materno Infantil Fernando Figueira
City
Recife
State/Province
Pernambuco
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
16860159
Citation
Ambalavanan N, Carlo WA. Ventilatory strategies in the prevention and management of bronchopulmonary dysplasia. Semin Perinatol. 2006 Aug;30(4):192-9. doi: 10.1053/j.semperi.2006.05.006.
Results Reference
background
PubMed Identifier
16625223
Citation
Bancalari E, del Moral T. Continuous positive airway pressure: early, late, or stay with synchronized intermittent mandatory ventilation? J Perinatol. 2006 May;26 Suppl 1:S33-7; discussion S43-5. doi: 10.1038/sj.jp.7211471.
Results Reference
background
PubMed Identifier
10835057
Citation
Van Marter LJ, Allred EN, Pagano M, Sanocka U, Parad R, Moore M, Susser M, Paneth N, Leviton A. Do clinical markers of barotrauma and oxygen toxicity explain interhospital variation in rates of chronic lung disease? The Neonatology Committee for the Developmental Network. Pediatrics. 2000 Jun;105(6):1194-201. doi: 10.1542/peds.105.6.1194.
Results Reference
background
PubMed Identifier
17703184
Citation
Bhandari V, Gavino RG, Nedrelow JH, Pallela P, Salvador A, Ehrenkranz RA, Brodsky NL. A randomized controlled trial of synchronized nasal intermittent positive pressure ventilation in RDS. J Perinatol. 2007 Nov;27(11):697-703. doi: 10.1038/sj.jp.7211805. Epub 2007 Aug 16.
Results Reference
background
PubMed Identifier
12650303
Citation
De Paoli AG, Davis PG, Lemyre B. Nasal continuous positive airway pressure versus nasal intermittent positive pressure ventilation for preterm neonates: a systematic review and meta-analysis. Acta Paediatr. 2003;92(1):70-5. doi: 10.1111/j.1651-2227.2003.tb00472.x.
Results Reference
background
PubMed Identifier
15141265
Citation
Santin R, Brodsky N, Bhandari V. A prospective observational pilot study of synchronized nasal intermittent positive pressure ventilation (SNIPPV) as a primary mode of ventilation in infants > or = 28 weeks with respiratory distress syndrome (RDS). J Perinatol. 2004 Aug;24(8):487-93. doi: 10.1038/sj.jp.7211131.
Results Reference
background
PubMed Identifier
15494823
Citation
Manzar S, Nair AK, Pai MG, Paul J, Manikoth P, Georage M, Al-Khusaiby SM. Use of nasal intermittent positive pressure ventilation to avoid intubation in neonates. Saudi Med J. 2004 Oct;25(10):1464-7.
Results Reference
background
PubMed Identifier
17452229
Citation
Kugelman A, Feferkorn I, Riskin A, Chistyakov I, Kaufman B, Bader D. Nasal intermittent mandatory ventilation versus nasal continuous positive airway pressure for respiratory distress syndrome: a randomized, controlled, prospective study. J Pediatr. 2007 May;150(5):521-6, 526.e1. doi: 10.1016/j.jpeds.2007.01.032.
Results Reference
background
PubMed Identifier
21262883
Citation
Meneses J, Bhandari V, Alves JG, Herrmann D. Noninvasive ventilation for respiratory distress syndrome: a randomized controlled trial. Pediatrics. 2011 Feb;127(2):300-7. doi: 10.1542/peds.2010-0922. Epub 2011 Jan 24.
Results Reference
derived

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Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome

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