Nasal Intermittent Positive Pressure Ventilation(NIPPV) vs Continuous Positive Airway Pressure for Respiratory Distress Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2020-07-30

Brief Summary

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In the past, several studies have compared the effects between nasal intermittent positive pressure ventilation(NIPPV) and nasal continuous positive airway pressure(NCPAP) on the incidence of intubation in preterm infants, and the results were inconsistent.The purpose of the present study was to compare NIPPV with NCPAP on the need for endotracheal ventilation and subsequent complications

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Detailed Description

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To this day, early use of noninvasive respiratory support strategies has been suggested to be the most effective pathway to reduce those risks. Nasal continuous positive airway pressure (NCPAP) and nasal intermittent positive pressure ventilation (NIPPV) are two widely used ways of noninvasive ventilation strategies in preterm infant. As compared with invasive ventilation, NCPAP reduces the risks abnormal neurodevelopment. However, there is only 60% success rate of avoiding intubation in the preterm neonate supported with NCPAP. Supplying with an intermittent peak pressure on NCPAP, NIPPV is considered as a strengthened version of NCPAP with increased flow delivery in the upper airway, increased minute volume and functional residual capacity and recruitment of collapsed alveoli, improved stability of the chest wall and reduced asynchrony of thoraco-abdominal movement,which have been proven to be crucial to decrease the incidences of invasive ventilation and death. However, studies have compared the effects between nasal intermittent positive pressure ventilation(NIPPV) and nasal continuous positive airway pressure(NCPAP) on the incidence of intubation in preterm infants, and the results were inconsistent.

Conditions

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Nasal Intermittent Positive Pressure Ventilation Nasal Continuous Positive Airway Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NIPPV

NIPPV is used as a primary mode of ventilation in premature infants with respiratory distress syndrome

Group Type EXPERIMENTAL

NIPPV

Intervention Type DEVICE

NIPPV is used as a primary mode of ventilation in premature infants with respiratory distress syndrome

NCPAP

NCPAP is used as a primary mode of ventilation in premature infants with respiratory distress syndrome

Group Type ACTIVE_COMPARATOR

NCPAP

Intervention Type DEVICE

NCPAP is used as a primary mode of ventilation in premature infants with respiratory distress syndrome

Interventions

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NIPPV

NIPPV is used as a primary mode of ventilation in premature infants with respiratory distress syndrome

Intervention Type DEVICE

NCPAP

NCPAP is used as a primary mode of ventilation in premature infants with respiratory distress syndrome

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Gestational age (GA) is from 26 to 37 weeks;
* Diagnosis of RDS. The diagnosis of respiratory distress syndrome(RDS) will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings;
* RDS Silverman score\>5;
* Informed parental consent has been obtained.

Exclusion Criteria

* Severe RDS requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation;
* Major congenital malformations or complex congenital heart disease;
* Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage;
* Cardiopulmonary arrest needing prolonged resuscitation;
* Transferred out of the neonatal intensive care unit without treatment.

Minimum Eligible Age

5 Minutes

Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No