Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome

NCT00821119 | Completed Results

• 1 other identifier: IMIP123
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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)

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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)

Secondary Outcomes (1)

• Bronchopulmonary Dysplasia

  at 36 weeks gestational age

Study Arms (2)

NCPAP

ACTIVE COMPARATOR

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

NIPPV

EXPERIMENTAL

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

Interventions

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

Also known as: NIPPV

NCPAP; NIPPV

Eligibility Criteria

• Age: 1 Day - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• preterm infants with RDS
• assigned to non invasive ventilation

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Materno Infantil Prof. Fernando Figueira: lead

Study Sites (2)

Maternal Infant Institute Prof Fernando Figueira

Recife, Pernambuco, 50.070-550, Brazil

Location

Instituto materno Infantil Fernando Figueira

Recife, Pernambuco, Brazil

Location

Related Publications (9)

• 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.

  PMID: 16860159 BACKGROUND

• 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.

  PMID: 16625223 BACKGROUND

• 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.

  PMID: 10835057 BACKGROUND

• 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.

  PMID: 17703184 BACKGROUND

• 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.

  PMID: 12650303 BACKGROUND

• 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.

  PMID: 15141265 BACKGROUND

• 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.

  PMID: 15494823 BACKGROUND

• 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.

  PMID: 17452229 BACKGROUND

• 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.

  PMID: 21262883 DERIVED

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Jucille Meneses
• Organization: Instituto Materno Infantil prof. Fernando Figueira

jmeneses@elogica.com.br

55 (81) 2122-4100

Study Officials

• Joao Guilherme B Alves, PhD

  Instituto Materno Infantil Prof. Fernando Figueira

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jucille Meneses Md PhD

Study Record Dates

• First Submitted: January 12, 2009
• First Posted: January 13, 2009
• Study Start: August 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 12, 2013
• Results First Posted: February 11, 2013

Record last verified: 2013-03

Locations

BR (2)