Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jucille do Amaral Meneses, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:
NCT00821119
First received: January 12, 2009
Last updated: March 3, 2013
Last verified: March 2013
  Purpose

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)


Condition Intervention
Prematurity
Respiratory Distress Syndrome
Device: nasal intermittent positive pressure ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Instituto Materno Infantil Prof. Fernando Figueira:

Primary Outcome Measures:
  • Need for Endotracheal Ventilation in the First 72 hs of Life [ Time Frame: first 72 hs of life ] [ Designated as safety issue: No ]
    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) [ Time Frame: first 3 days of life(72hours) ] [ Designated as safety issue: No ]
    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 [ Time Frame: at 36 weeks gestational age ] [ Designated as safety issue: No ]
    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.


Enrollment: 200
Study Start Date: August 2007
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NCPAP
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
Device: nasal intermittent positive pressure ventilation
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
Other Name: NIPPV
Experimental: NIPPV
preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support in preterm infants with respiratory distress syndrome
Device: nasal intermittent positive pressure ventilation
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
Other Name: NIPPV

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.

  Eligibility

Ages Eligible for Study:   up to 1 Day
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • preterm infants with RDS
  • assigned to non invasive ventilation

Exclusion Criteria:

  • preterm on endotracheal ventilation
  • severe congenital pulmonary or cardiovascular malformation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821119

Locations
Brazil
Maternal Infant Institute Prof Fernando Figueira
Recife, Pernambuco, Brazil, 50.070-550
Instituto materno Infantil Fernando Figueira
Recife, Pernambuco, Brazil
Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira
Investigators
Study Director: Joao Guilherme B Alves, PhD Instituto Materno Infantil Prof. Fernando Figueira
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jucille do Amaral Meneses, Jucille Meneses Md PhD, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT00821119     History of Changes
Other Study ID Numbers: IMIP123
Study First Received: January 12, 2009
Results First Received: September 24, 2012
Last Updated: March 3, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Instituto Materno Infantil Prof. Fernando Figueira:
non invasive ventilation
mechanical ventilation
pulmonary morbidity
preterm infant
Respiratory distress syndrome
nasal intermittent positive pressure
nasal continuous positive pressure
bronchopulmonary dysplasia

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on April 17, 2014