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

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

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

Study Overview

• Status: Unknown
• Conditions: Nasal Continuous Positive Airway Pressure; Nasal Intermittent Positive Pressure Ventilation
• Intervention / Treatment: Device: NIPPV; Device: NCPAP

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 Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Recruiting
      • Department of Pediatrics, Daping Hospital, Third Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 minutes to 6 hours (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Collaborators: Children's Hospital of Fudan University; Chengdu Women's and Children's Central Hospital; Kunming Children's Hospital; Guangdong Women and Children Hospital; The Children's Hospital of Zhejiang University School of Medicine; Nanjing Children's Hospital; Children's Hospital of Chongqing Medical University; Shanxi Provincial Maternity and Children's Hospital; Yan'an Affiliated Hospital of Kunming Medical University; Chongqing Maternal and Child Health Hospital; Jiulongpo No.1 People's Hospital; Guiyang Maternity and Child Health Care Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): July 30, 2020
• Study Completion (Anticipated): July 30, 2020

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 24, 2017
• Last Update Submitted That Met QC Criteria: July 21, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: NIPPV of multicenter

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No