Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome

Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821119
• Other study ID #: IMIP123
• Status: Completed
• Phase: N/A
• First received: January 12, 2009
• Last updated: March 3, 2013
• Start date: August 2007
• Est. completion date: September 2009

Study information

• Verified date: March 2013
• Source: Instituto Materno Infantil Prof. Fernando Figueira
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Day

Eligibility

Inclusion Criteria:

• preterm infants with RDS

• assigned to non invasive ventilation

Exclusion Criteria:

• preterm on endotracheal ventilation

• severe congenital pulmonary or cardiovascular malformation

Study Design

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

Related Conditions & MeSH terms

• Prematurity
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Brazil	Instituto materno Infantil Fernando Figueira	Recife	Pernambuco
Brazil	Maternal Infant Institute Prof Fernando Figueira	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Materno Infantil Prof. Fernando Figueira

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

Ambalavanan N, Carlo WA. Ventilatory strategies in the prevention and management of bronchopulmonary dysplasia. Semin Perinatol. 2006 Aug;30(4):192-9. Review. — View 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. Review. — View 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. Epub 2007 Aug 16. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	first 72 hs of life	No
Primary	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	first 3 days of life(72hours)	No
Secondary	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.	at 36 weeks gestational age	No