A Trial of Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Pressure for Respiratory Distress Syndrome (RDS) - Full Text View

Sponsored by:	Instituto Materno Infantil Prof. Fernando Figueira
Information provided by:	Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:	NCT00821119

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: non invasive ventilation (NCPAP) Device: non-invasive ventilation (NIPP)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
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

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

Primary Outcome Measures:

Need for endotracheal ventilation [ Time Frame: first 5 days of life ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of bronchopulmonary dysplasia [ Time Frame: 36 weeks post gestational ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	March 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 - NCPAP: Active Comparator preterm infants with nasal continuous positive pressure as the mode of respiratory support	Device: non invasive ventilation (NCPAP) Nasal continuous positive airway pressure. The types of non invasive ventilation that will be compared are the nasal continuous positive pressure versus the nasal intermittent positive pressure ventilation.
2- NIPP: Active Comparator preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support	Device: non-invasive ventilation (NIPP) Nasal intermittent positive pressure. The types of non invasive ventilation that will be compared are the nasal continuous positive pressure versus the nasal intermittent positive pressure ventilation.

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, Pernambuco
Maternal Infant Institute Prof Fernando Figueira
Recife, Pernambuco, Brazil, 50.070-550

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:

Ambalavanan N, Carlo WA. Ventilatory strategies in the prevention and management of bronchopulmonary dysplasia. Semin Perinatol. 2006 Aug;30(4):192-9. Review.

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. Review.

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.

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. Epub 2007 Aug 16.

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. Review.

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.

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.

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.

Responsible Party:	Neonatal Unit of the Maternal-Infant Institute Prof. Fernando Figueira ( Jucille do Amaral Meneses )
Study ID Numbers:	IMIP123
Study First Received:	January 12, 2009
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00821119
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

Study placed in the following topic categories:

Bronchopulmonary dysplasia
Bronchopulmonary Dysplasia
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute respiratory distress syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009