Successful Extubation and Noninvasive Ventilation in Preterm ≤ 1500g Terms

February 2, 2016 updated by: Simone Nascimento Santos Ribeiro, Federal University of Minas Gerais

Successful Extubation and Noninvasive Ventilation in Preterm Infants ≤ 1500g Terms

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NIPPV
NIPPV - Newborns randomized to this group underwent NIPPV, in noninvasive ventilation support intermittent, in TIME mode of the respirator.
Device: NIPPV
Ventilation with nasal intermittent positive pressure - Newborns randomized to this group underwent NIPPV, the respirators in TIME mode, set with the following settings : 5-6 centimeters of water (cmH2O) pressure positive end expiratory (PEEP); Flow rate of 6-8 liters per minute (L / min); PIP(positive inspiratory pressure) < 15 centimeters of water (cm H2O) ; respiratory frequency backup (FR) < 16 bpm; inspiratory time (IT) - 0.30 to 0.33 seconds (adjustable time constant according to the weight and baseline disease)
Other Names:
  • Non invasive ventilation
Placebo Comparator: Bubble NCPAP
Bubble NCPAP - Newborns randomized to this group bubble NCPAP, in noninvasive ventilation continuous, in bubble NCPAP.
Device: Bubble NCPAP
Bubble NCPAP - Newborns randomized to this group bubble NCPAP, adjusted with the following settings: pressure positive end expiratory (PEEP) 5-6 centimeters of water (cm H2O) and Flow 6-8 liters per minute (L / min), provided through oxygen sources and compressed air (15 liters per minute - L / min), which passes through a heated humidifier through a breathing circuit that goes to the newborn, and from him, for a plastic container (250 milliliters (ml) capacity and 14 centimeters) containing sterile distilled water, which is the bubble.
Placebo Comparator: Ventilator NCPAP
Ventilator NCPAP - Newborns randomized to this group ventilator NCPAP, in noninvasive ventilation continuous, in NCPAP mode of the respirator.
Device: Ventilator NCPAP
Ventilator NCPAP - Newborns randomized to this group ventilator NCPAP, of respirators in TIME mode set with the following settings: pressure positive end expiratory (PEEP) 5-6 centimeters of water (cm H2O) and Flow 6-8 liters per minute (L / min).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The success rate of the extubation
Time Frame: 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
Finished The newborns were followed for all interaction until discharge (about 5 weeks).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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).
Finished The newborns were followed for all interaction until discharge (about 5 weeks).
The failure and success of the noninvasive support (days of oxygen use, mechanical ventilation (VPM) and occurrence of bronchopulmonary dysplasia (BPD)
Time Frame: 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)
Finished The newborns were followed for all interaction until discharge (about 5 weeks).
Incidence of the diseases during the hospitalization
Time Frame: 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
Finished The newborns were followed for all interaction until discharge (about 5 weeks).
Outcomes at discharge in days (Total number of days in use oxygen, mechanical ventilation and death, and hospitalization duration)
Time Frame: 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
Finished The newborns were followed for all interaction until discharge (about 5 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Investigators

  • Study Chair: Cíntia Johnston, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

January 28, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Estimate)

February 3, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUMinasGerais

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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