Successful Extubation and Noninvasive Ventilation in Preterm ≤ 1500g Terms

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome In Premature Infants
• Interventions: Device: Bubble NCPAP; Device: NIPPV; Device: Ventilator NCPAP

• Registration Number: NCT02396693
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

Noninvasive ventilation has been used in preterm newborn with respiratory distress syndrome in an attempt to assist failure extubation. The investigators investigated failure extubation in infants gestational age less than or equal to 34 weeks and weights less than or equal to 1500 grams. Neonates were randomized to noninvasive modalities support. 101 newborns were included in this study in three groups , group 1: Nasal Intermittent Positive Pressure Ventilation (NIPPV) (n=36), group 2: Nasal Continuous Positive Airway Pressure Bubble (NCPAP bubble) (n=33) and group 3: Nasal Continuous Positive Airway Pressure Bubble Ventilator (NCPAP ventilator) (n=32)

Detailed Description

The infants were randomly allocated after extubation used a list of computer-generated randomization in NIPPV modes (with the following settings: positive inspiratory pressure (PIP) \< 16 centimeters of water (cm H2O), positive end-expiratory pressure (PEEP) 4-5 centimeters of water (cm H2O, backup respiratory rate (RR) \< 18 cycles per minute flow 6-7 liters per minute (L / min) and inspiratory time (TI) according to the time constant for idae (0.30 to 0.34 seconds), and respirator seal to NCPAP water tower was adjusted to 4-5 centimeters of water (cm H2O) PEEP, flow 6-7 liters per minute (L / Min.) oxygen for both was adjusted to maintain arterial oxygen saturation between 85-95%

The criteria for extubation were defined using a protocol by the clinic staff, confirmed by arterial blood gases and chest X-ray, as well as adjustments of the ventilator settings.

Vital signs, blood gas parameters and noninvasive brackets were recorded before, immediately, 15, 30, 45 minutes, 1(hour) h, 2h, 12h, 24h and 48 h after extubation were documented.

Neonatal morbidities were documented until discharge, among these are: patent ductus arterious, necrotizing enterocolitis, retinopathy of prematurity, intracranial hemorrhage and pneumothorax.

Data on achievement of prenatal, antenatal steroids and surfactant administration were documented. All newborns were natural porcine surfactant Curosurf®.

The total duration of mechanical ventilation and oxygen were documented from birth until discharge or death. The supplemental oxygen or mechanical ventilation days was defined as daily requirement of fraction of inspired oxygen (FiO 2)\> 0.21 or ventilation \> 12 hours, respectively.

The newborns were followed for all interaction until discharge (about 5 weeks).

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2015-01-28
• Study First Submitted QC: 2015-03-18
• Study First Posted: 2015-03-24
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Were eligible for the study
• Newborn (NB) ≤ 34 weeks and 500g to the weight of ≤ 1500 grams with a diagnosis of respiratory distress syndrome (RDS) who had their first elective extubation.

Exclusion Criteria

• Excluded patients with cardiorespiratory system malformations
• Genetic disorders
• Neuromuscular disease and malformations of the central nervous system.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bubble NCPAP	Bubble NCPAP	Bubble NCPAP - Newborns randomized to this group bubble NCPAP, in noninvasive ventilation continuous, in bubble NCPAP.
NIPPV	NIPPV	NIPPV - Newborns randomized to this group underwent NIPPV, in noninvasive ventilation support intermittent, in TIME mode of the respirator.
Ventilator NCPAP	Ventilator NCPAP	Ventilator NCPAP - Newborns randomized to this group ventilator NCPAP, in noninvasive ventilation continuous, in NCPAP mode of the respirator.

Primary Outcome Measures

Name	Time	Method
The success rate of the extubation	Finished The newborns were followed for all interaction until discharge (about 5 weeks).	The success rate of the extubation and Need for intubation within the first 48 hours after extubation in the three groups

Secondary Outcome Measures

Name	Time	Method
Correlations of the noninvasive support (correlations with sex, gestational age (IG), total duration of oxygen use, full-time use of mechanical ventilation and bronchopulmonary dysplasia (DBP)	Finished The newborns were followed for all interaction until discharge (about 5 weeks).	Related to noninvasive support and correlations with sex, gestational age (IG), total duration of oxygen use, full-time use of mechanical ventilation and bronchopulmonary dysplasia (DBP).
The failure and success of the noninvasive support (days of oxygen use, mechanical ventilation (VPM) and occurrence of bronchopulmonary dysplasia (BPD)	Finished The newborns were followed for all interaction until discharge (about 5 weeks).	The failure vs. success, with the days of oxygen use, mechanical ventilation (VPM) and occurrence of bronchopulmonary dysplasia (BPD)
Incidence of the diseases during the hospitalization	Finished The newborns were followed for all interaction until discharge (about 5 weeks).	Incidence of pneumothorax, patent ductus arterious (PDA), retinopathy of prematurity (HOP), peri-intraventricular hemorrhage (HPIV), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), nasal injury
Outcomes at discharge in days (Total number of days in use oxygen, mechanical ventilation and death, and hospitalization duration)	Finished The newborns were followed for all interaction until discharge (about 5 weeks).	Total number of days in use oxygen, mechanical ventilation and death, and hospitalization duration