Clinical trial NCT03226977: Nasal Intermittent Positive Pressure Ventilation(NIPPV) vs Continuous Positive Airway Pressure for Respiratory Distress Syndrome
Official title: Nasal Intermittent Positive Pressure Ventilation vs Continuous Positive Airway Pressure for Preterm Infants With Respiratory Distress Syndrome:a Multicenter Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasal Intermittent Positive Pressure Ventilation
Nasal Continuous Positive Airway Pressure
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Guiyang Maternity and Child Health Care Hospital
name: Children's Hospital of Chongqing Medical University
name: Chongqing Maternal and Child Health Hospital
name: Yan'an Affiliated Hospital of Kunming Medical University
name: The Children's Hospital of Zhejiang University School of Medicine
name: Chengdu Women's and Children's Central Hospital
name: Kunming Children's Hospital
name: Shanxi Provincial Maternity and Children's Hospital
name: Children's Hospital of Fudan University
name: Guangdong Women and Children Hospital
name: Nanjing Children's Hospital
name: Jiulongpo No.1 People's Hospital
First posted: 2017-07-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: intubation rate
timeFrame: within 7 days
Secondary outcomes:
measure: Intraventricular hemorrhage
timeFrame: within 28 days
measure: bronchopulmonary dysplasia
timeFrame: at a post-menstrual age of 36 weeks or at discharge
measure: Bayley Scales of Infant Development
timeFrame: at 2 months old and 2 years old
measure: Neonatal necrotizing enterocolitis(NEC)
timeFrame: within 7 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Pediatrics, Daping Hospital, Third Military Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Shi Yuan, PhD,MD
role: STUDY_DIRECTOR
References: