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Completed

NCT Number: NCT00821119

Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome

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)

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Key information

Conditions

Prematurity Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

1 day–1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto materno Infantil Fernando Figueira, Recife, Pernambuco, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • preterm infants with RDS
  • assigned to non invasive ventilation

Exclusion criteria

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

Treatment and study plan

nasal intermittent positive pressure ventilation

Device

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 names: NIPPV

Primary outcomes

  1. Need for Endotracheal Ventilation in the First 72 hs of Life

    Time frame: first 72 hs of life

    number of participants that needed endotracheal ventilation (failed non invasive ventilation) in the first 72 hours of life

  2. Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP)

    Time frame: first 3 days of life(72hours)

    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 outcomes

  1. Bronchopulmonary Dysplasia

    Time frame: at 36 weeks gestational age

    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.

Sponsors and collaborators

Lead sponsor

Instituto Materno Infantil Prof. Fernando Figueira

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 13, 2009
Registry last updated
Mar 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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