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Impact of Synchronized Nasal Intermittent Positive Pressure Ventilation Using NAVA in Preterm Infants With RDS

NCT02030652 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2015-08-19

No results posted yet for this study

Summary

The nasal CPAP (continuous positive airway pressure), is a technique of noninvasive ventilation commonly used in neonatal intensive care units, and has recently been used in association with nasal intermittent mandatory ventilation (NIPPV - intermittent Nasal Positive Pressure Ventilation), which consists of the application of respiratory positive pressure cycles during the application of nasal CPAP, resulting in high pharyngeal pressures. The NIPPV has advantages over traditional CPAP, including the prevention of atelectasis, improved respiratory mechanics and decreased work of breathing in premature infants. A refinement of this technique is the use of positive pressure breaths associated with nasal CPAP synchronously in relation to the newborn's inspiratory effort (SNIPPV - Synchronized Nasal Positive Pressure Ventilation).

Synchronization allows that the cycles of inspiratory positive pressure provided by the ventilator coincide with the inspiratory effort, increasing the system efficacy. The Neurally Adjusted Ventilatory Assist (NAVA) is a mode of partial ventilatory support based on the use of electrical activity of the diaphragm (Edi) to control the mechanical ventilator. The ventilatory assistance starts according to respiratory needs of the patient, its use in very low birth weight infants showed an improvement in patient-ventilator interaction, even in the presence of leak around the endotracheal tube. This prospective randomized, clinical trial aims to evaluate, in preterm infants with gestational age lower than 34 weeks with respiratory failure treated with noninvasive ventilatory support, the impact of SNIPPV with neural adjustment (NAVA) on success ventilation and the need for endotracheal intubation when compared to treatment with traditional CPAP.

Conditions

  • Respiratory Distress Syndrome

Interventions

PROCEDURE

Intermittent nasal positive pressure positive ventilation.

PROCEDURE

CPAP

Nasal continuous positive airway pressure

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Hospital Israelita Albert Einstein

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
23 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-11-30
Completion
2015-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02030652 on ClinicalTrials.gov