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

Not Applicable

• Conditions: Nasal Intermittent Positive Pressure Ventilation; Nasal Continuous Positive Airway Pressure
• Interventions: Device: NIPPV; Device: NCPAP

• Registration Number: NCT03226977
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-21
• Last Update Submitted: 2017-07-21
• Study First Posted: 2017-07-24
• Last Update Posted: 2017-07-24
• Study Start: 2017-08-01
• Primary Completion: 2020-07-30
• Study Completion: 2020-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
intubation rate	within 7 days	the infant is intubated ventilation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Pediatrics, Daping Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China