Prematurity, Respiratory Distress Syndrome
Conditions
Keywords
non invasive ventilation, mechanical ventilation, pulmonary morbidity, preterm infant, Respiratory distress syndrome, nasal intermittent positive pressure, nasal continuous positive pressure, bronchopulmonary dysplasia
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)
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.
Interventions
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
Sponsors
Instituto Materno Infantil Prof. Fernando Figueira
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Days
Healthy volunteers
No
Inclusion criteria
* preterm infants with RDS * assigned to non invasive ventilation
Exclusion criteria
* preterm on endotracheal ventilation * severe congenital pulmonary or cardiovascular malformation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for Endotracheal Ventilation in the First 72 hs of Life | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bronchopulmonary Dysplasia | at 36 weeks gestational age | 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. |
Countries
Brazil
Participant flow
Recruitment details
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
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 1 - NCPAP preterm infants with nasal continuous positive pressure as the mode of respiratory support | 100 |
| 2- NIPP preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | 2- NIPP | 1 - NCPAP | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 100 Participants | 100 Participants | 200 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 29 weeks of gestation STANDARD_DEVIATION 1.6 | 30.1 weeks of gestation STANDARD_DEVIATION 2.3 | 30 weeks of gestation STANDARD_DEVIATION 1.2 |
| Region of Enrollment Brazil | 100 participants | 100 participants | 200 participants |
| Sex: Female, Male Female | 49 Participants | 51 Participants | 100 Participants |
| Sex: Female, Male Male | 51 Participants | 49 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
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
Time frame: first 3 days of life(72hours)
Population: 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%.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NCPAP | Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP) | 34 participants |
| NIPPV | Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP) | 25 participants |
Comparison: Based on previous data from our NICU, 40 - 45% of our preterm infants administered early 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%.p-value: 0.0595% CI: [0.48, 1.14]risk ratio (RR)
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
Time frame: first 72 hs of life
Population: 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%.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| NCPAP | Need for Endotracheal Ventilation in the First 72 hs of Life | 34 participants | 0 |
| NIPPV | Need for Endotracheal Ventilation in the First 72 hs of Life | 25 participants | 0 |
Comparison: Based on previous data from our NICU, 40 - 45% of our preterm infants administered early 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%.~The analysis was performed according to the intention-to-treat principle.p-value: <0.0595% CI: [0.48, 1.14]risk ratio (RR)
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.
Time frame: at 36 weeks gestational age
Population: The number of preterm infants surviving to 36 weeks postmenstrual age were eligible for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NCPAP | Bronchopulmonary Dysplasia | 20 participants |
| NIPPV | Bronchopulmonary Dysplasia | 22 participants |
Comparison: The study was not powered for this outcome. However this analysis was done with this limitationp-value: <0.0595% CI: [0.62, 1.78]risk ratio (RR)