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

Army Medical University of People's Liberation Army

Status: Unknown

Conditions: Nasal Continuous Positive Airway Pressure; Nasal Intermittent Positive Pressure Ventilation

Treatments: Device: NIPPV; Device: NCPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT03226977

NIPPV of multicenter

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 5 minutes to 6 hours old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,000 participants in 2 patient groups

NIPPV

Experimental group

Description:

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

Treatment:

Device: NIPPV

NCPAP

Active Comparator group

Description:

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

Treatment:

Device: NCPAP