PrematurityNCT00821119

Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome

A study testing nasal intermittent positive pressure ventilation in people with Prematurity and Respiratory Distress Syndrome, run by Instituto Materno Infantil Prof. Fernando Figueira at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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) Read more about this study

Who is it for?: Ages 1 to 1 day
Conditions the study is for: Prematurity, Respiratory Distress Syndrome
What is being tested?: nasal intermittent positive pressure ventilation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 2 sitesBrazil
Study dates: Aug 2007to Sep 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 to 1 day
All sexes
No healthy volunteers
Child

Who may be able to join

preterm infants with RDS
assigned to non invasive ventilation

Who cannot join

preterm on endotracheal ventilation
severe congenital pulmonary or cardiovascular malformation

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

Maternal Infant Institute Prof Fernando Figueira
Recife, Pernambuco, 50.070-550
Instituto materno Infantil Fernando Figueira
Recife, Pernambuco

Other trials in Brazil

About this 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

Read the 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.

Conditions: Prematurity, Respiratory Distress Syndrome
Being tested: nasal intermittent positive pressure ventilation
Keywords: non invasive ventilation, mechanical ventilation, pulmonary morbidity, preterm infant, Respiratory distress syndrome, nasal intermittent positive pressure, nasal continuous positive pressure, bronchopulmonary dysplasia
Medical subject headings: Premature Birth, Respiratory Distress Syndrome, Bronchopulmonary Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

nasal intermittent positive pressure ventilationDevice
Also called NIPPV
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

Study groups in NCT00821119
Study group	Role	What they receive
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 Receives: 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 Receives: Device: nasal intermittent positive pressure ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: first 3 days of life(72hours)

Secondary outcomes (1)

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.
Measured: at 36 weeks gestational age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2007Sep 2009

First posted13 Jan 2009 (estimated)
Study startAug 2007
Primary completionJul 2009
Study completionSep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for PrematurityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00821119
Sponsor's protocol ID: IMIP123
Status last verified: Mar 2013
First submitted: 12 Jan 2009
Last updated: 12 Mar 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 16860159
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.
PubMed 16625223
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.
PubMed 10835057
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.
PubMed 17703184
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.
PubMed 12650303
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.
PubMed 15141265
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.
PubMed 15494823
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.
PubMed 17452229
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.
PubMed 21262883

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia

All Prematurity trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00821119
Acronym / sponsor ID: IMIP123
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
Study start: Aug 2007
Primary completion: Jul 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 13 Jan 2009 (estimated)
Results: Posted 22 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
NCPAP	Active comparator	Device: nasal intermittent positive pressure ventilationpreterm 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
NIPPV	Experimental	Device: nasal intermittent positive pressure ventilationpreterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support in preterm infants with respiratory distress syndrome

Who may qualify

Ages: 1 to 1 day
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

preterm infants with RDS
assigned to non invasive ventilation

Key exclusion criteria (2 listed)

preterm on endotracheal ventilation
severe congenital pulmonary or cardiovascular malformation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
nasal intermittent positive pressure ventilationAlso: NIPPVNasal 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	Device	NCPAP, NIPPV

Primary outcome

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
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

1 secondary outcome

Bronchopulmonary Dysplasia
Time frame: at 36 weeks gestational age

Results and safety

Results posted to the registry on 22 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nasal Continuous Positive Airway Pressure (NCPAP)	100	100
Nasal Intermittent Positive Pressure Ventilation (NIPPV)	100	100

Primary outcome: Need for Endotracheal Ventilation in the First 72 hs of Life

Time frame: first 72 hs of life. Number. Unit: participants

Measure	NCPAP n = 100	NIPPV n = 100
Value	34 (0)	25 (0)

NCPAP vs NIPPV: Risk Ratio (RR): 0.70 (95% CI 0.48 to 1.14), p <0.05, risk ratio (RR)

Population analysed: 40 - 45% of our previous preterm infants on NCPAP for RDS needed intubation and mechanical ventilation within the first 72h of life. We estimated a 20% absolute reduction in the need of using ETT ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.

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

Time frame: first 3 days of life(72hours). Number. Unit: participants

Measure	NCPAP n = 100	NIPPV n = 100
Value	34 (0.48 to 1.14)	25 (0.48 to 1.14)

NCPAP vs NIPPV: Risk Ratio (RR): 0.70 (95% CI 0.48 to 1.14), p = 0.05, risk ratio (RR)

Population analysed: We estimated a 20% absolute reduction in the need of using endotraqueal ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected during 2 years. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 - NCPAP	0 of 100 (0%)	0 of 100 (0%)	Not reported
2- NIPP	0 of 100 (0%)	0 of 100 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16860159Ambalavanan 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.
Background: PubMed 16625223Bancalari 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.
Background: PubMed 10835057Van 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.
Background: PubMed 17703184Bhandari 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.
Background: PubMed 12650303De 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.
Background: PubMed 15141265Santin 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.
Background: PubMed 15494823Manzar 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.
Background: PubMed 17452229Kugelman 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.
Derived from this study: PubMed 21262883Meneses 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.

Related trials for Prematurity

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nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
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Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
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Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joao Guilherme B Alves, PhD study director

Instituto Materno Infantil Prof. Fernando Figueira

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Need for Endotracheal Ventilation in the First 72 hs of Life (time frame: first 72 hs of life). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00821119, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2013.