Trial Outcomes & Findings for Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome (NCT NCT00821119)

Results Overview

number of participants that needed endotracheal ventilation (failed non invasive ventilation) in the first 72 hours of life

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

200 participants

Primary outcome timeframe

first 72 hs of life

Results posted on

2013-03-12

Participant Flow

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

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

Participant milestones

Participant milestones
Measure	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%.	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%.
Overall Study STARTED	100	100
Overall Study COMPLETED	100	100
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 - NCPAP n=100 Participants preterm infants with nasal continuous positive pressure as the mode of respiratory support	2- NIPP n=100 Participants preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	30.1 weeks of gestation STANDARD_DEVIATION 2.3 • n=5 Participants	29 weeks of gestation STANDARD_DEVIATION 1.6 • n=7 Participants	30 weeks of gestation STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	49 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	51 Participants n=7 Participants	100 Participants n=5 Participants
Region of Enrollment Brazil	100 participants n=5 Participants	100 participants n=7 Participants	200 participants n=5 Participants

PRIMARY outcome

Timeframe: 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%.

number of participants that needed endotracheal ventilation (failed non invasive ventilation) in the first 72 hours of life

Outcome measures

Outcome measures
Measure	NCPAP n=100 Participants preterm infants with nasal continuous positive pressure as the mode of respiratory support	NIPPV n=100 Participants preterm infants with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
Need for Endotracheal Ventilation in the First 72 hs of Life	34 participants 0	25 participants 0

PRIMARY outcome

Timeframe: 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%.

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

Outcome measures

Outcome measures
Measure	NCPAP n=100 Participants preterm infants with nasal continuous positive pressure as the mode of respiratory support	NIPPV n=100 Participants preterm infants with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP)	34 participants Interval 0.48 to 1.14	25 participants Interval 0.48 to 1.14

SECONDARY outcome

Timeframe: at 36 weeks gestational age

Population: The number of preterm infants surviving to 36 weeks postmenstrual age were eligible for analysis

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.

Outcome measures

Outcome measures
Measure	NCPAP n=80 Participants preterm infants with nasal continuous positive pressure as the mode of respiratory support	NIPPV n=83 Participants preterm infants with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
Bronchopulmonary Dysplasia	20 participants	22 participants

Adverse Events

1 - NCPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2- NIPP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jucille Meneses

Instituto Materno Infantil prof. Fernando Figueira

Phone: 55 (81) 2122-4100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place