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

Study Overview
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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

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.

Official Title
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Nasal Intermittent Positive Pressure Ventilation vs Continuous Positive Airway Pressure for Preterm Infants With Respiratory Distress Syndrome:a Multicenter Randomized Controlled Study

Conditions
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Nasal Intermittent Positive Pressure Ventilation, Nasal Continuous Positive Airway Pressure

Intervention / Treatment
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* Device: NIPPV
* Device: NCPAP


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Minutes
Maximum Age: 6 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIPPV<br>NIPPV is used as a primary mode of ventilation in premature infants with respiratory distress syndrome | Device: NIPPV<br>* NIPPV is used as a primary mode of ventilation in premature infants with respiratory distress syndrome<br>|
| Active Comparator: NCPAP<br>NCPAP is used as a primary mode of ventilation in premature infants with respiratory distress syndrome | Device: NCPAP<br>* NCPAP is used as a primary mode of ventilation in premature infants with respiratory distress syndrome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubation rate | the infant is intubated ventilation | within 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraventricular hemorrhage | the incidence of intraventricular hemorrhage | within 28 days | 
| bronchopulmonary dysplasia | bronchopulmonary dysplasia was defined according to the National Institutes of Health consensus definition | at a post-menstrual age of 36 weeks or at discharge | 
| Bayley Scales of Infant Development | scores of Bayley Scales of Infant Development | at 2 months old and 2 years old | 
| Neonatal necrotizing enterocolitis(NEC) | the incidence of neonatal necrotizing enterocolitis(>stage II);for NEC, Bell staging will be used | within 7 days |