Effects of Two Modalities of Non-invasive Ventilation After Extubation in Very Low Birth Weight Neonates

Federal University of Minas Gerais

Status: Completed

Conditions: Preterm Infant

Treatments: Other: Nasal Intermittent Positive Pressure; Other: Continuous Positive Airway Pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT03551314

CAAE: 67787917.7.0000.5149

Details and patient eligibility

About

The objective of this study is to evaluate the effects of continuous positive airway pressure and nasal intermittent positive pressure ventilation on breathing pattern variables of very low birth weight neonates immediately after extubation.

Full description

The effects of non-invasive ventilation on the respiratory function of neonates have not been fully elucidated. Currently, two modalities of non invasive ventilation are commonly used in Brazilian neonatal intensive care units: continuous positive airway pressure (CPAP) and nasal intermittent positive pressure ventilation (NIPPV). In this study, it was hypothesized that NIPPV will improve tidal volume when compared to CPAP. The objective of this study is to evaluate the effects of continuous positive airway pressure and nasal intermittent positive pressure ventilation on breathing pattern variables of very low birth weight neonates immediately after extubation. Soon after extubation, the neonates will be randomized into the CPAP-NIPPV (sequence 1) or the NIPPV-CPAP (sequence 2). The sequence will be assigned at random using sealed envelopes. Respiratory inductive plethysmography will be used to evaluate the breathing pattern (tidal volume, respiratory rate, minute ventilation, mean inspiratory flow) and chest wall motion (labor breathing index, inspiratory phase relation, expiratory phase relation, total phase relation and phase angle). Student t tests for paired samples will be used and the Wilcoxon test according to the data distribution. A significance level of 5% will be adopted. The analyzes will be performed by StatisticalPackage software for the Social Sciences® (SPSS, Chicago, IL, USA), version 17.0 for Windows.

Enrollment: 17 patients

Sex: All

Ages: Under 32 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Presented gestational age less than or equal to 32 weeks and weight less than or equal to 1,500 g;
• Stability from an hemodynamic point of view (without use of amines);
• Have undergone invasive mechanical ventilation;
• Absence of congenital heart diseases and / or other congenital anomalies (myelomeningocele, gastroschisis and / or omphalocele) or chromosomal abnormalities;
• Absence of any condition that requires surgery in the neonatal period.

Exclusion criteria

• Presented air leak syndrome (pneumothorax, pneumomediastinum); upper airway obstruction after extubation and non-scheduled extubation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Nasal Intermittent Positive Pressure

Active Comparator group

Description:

In this group, soon after extubation, the newborns will be studied initially in NIPPV for one hour. Infants will be studied in supine while in their incubator. NIPPV: Nasal Intermittent Positive Pressure Ventilation

Treatment:

Other: Nasal Intermittent Positive Pressure

Continuous Positive Airway Pressure

Active Comparator group

Description:

In this group, soon after extubation, the newborns will be studied initially in CPAP for one hour. Infants will be studied in supine while in their incubator. CPAP: Continuous Positive Airway Pressure

Treatment:

Other: Continuous Positive Airway Pressure