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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| NIPPV | Experimental | preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support in preterm infants with respiratory distress syndrome |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joao Guilherme B Alves, PhD | Instituto Materno Infantil Prof. Fernando Figueira | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternal Infant Institute Prof Fernando Figueira | Recife | Pernambuco | 50.070-550 | Brazil | ||
| Instituto materno Infantil Fernando Figueira |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16860159 | Background | 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. | |
| 16625223 | 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. |
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Infants were excluded for any of the following reasons: major congenital anomalies, presence of cardiovascular instability, intubation at admission to the NICU, consent not provided or refused and unavailability of a ventilator. there were 423 eligible infants and 223 excluded, 200 participated in the study
The started study date of recruitment was March 2008 in a single center. One of the biggest hospital in the northeast of brazil with an inborn tertiary NICU
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| ID | Title | Description |
|---|---|---|
| FG000 | Nasal Continuous Positive Airway Pressure (NCPAP) | Continuous nasal positive airway pressure as a mode of respiratory support in preterm infants with respiratory distress syndrome from birth up to 72 hours of life. Infants randomized to the NCPAP group were initiated on a pressure of 5 - 6 cm H2O and a flow of 8 - 10L/m by an underwater seal (Bubble CPAP system, Intermed Inc., Sao Paulo, Brazil). Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%. |
| FG001 | Nasal Intermittent Positive Pressure Ventilation (NIPPV) | Nasal intermittent positive pressure ventilation as a mode of respiratory support in preterm infants with respiratory distress syndrome from birth up to 72 hours of life.We used a time-cycle, pressure-limited and continuous flow neonatal ventilator (Inter Neo, Intermed Inc., Sao Paulo, Brazil) for infants assigned to the NIPPV group, in the non-synchronized mode. The initial settings were: frequency of 20 to 30 breaths per minute, peak inspiratory pressure (PIP) of 15 to 20 cm H2O, peak end expiratory pressure (PEEP) of 4 - 6 cm H2O, inspiratory time (Ti) of 0.4 - 0.5 s and a flow of 8 - 10L/m.Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 - NCPAP | preterm infants with nasal continuous positive pressure as the mode of respiratory support |
| BG001 | 2- NIPP | preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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%. | Posted | Number | participants | first 72 hs of life |
|
Adverse event data were collected during 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 - NCPAP | preterm infants with nasal continuous positive pressure as the mode of respiratory support |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jucille Meneses | Instituto Materno Infantil prof. Fernando Figueira | 55 (81) 2122-4100 | 4135 | jmeneses@elogica.com.br |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D012128 | Respiratory Distress Syndrome |
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| Recife |
| Pernambuco |
| Brazil |
| 10835057 | 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. |
| 17703184 | 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. |
| 12650303 | 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. |
| 15141265 | 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. |
| 15494823 | 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. |
| 17452229 | 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. |
| 21262883 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | weeks of gestation |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
preterm infants with nasal intermittent positive pressure ventilation as a primary mode of respiratory support |
|
|
|
| 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 | 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%. | Posted | Number | participants | first 3 days of life(72hours) |
|
|
|
|
| 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. | The number of preterm infants surviving to 36 weeks postmenstrual age were eligible for analysis | Posted | Number | participants | at 36 weeks gestational age |
|
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | 2- NIPP | preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support | 0 | 100 | 0 | 100 |
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| D000091642 | Urogenital Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |