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

Nasal Continuous Positive Airway Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03226977
• Other study ID #: NIPPV of multicenter
• Status: Recruiting
• Phase: N/A
• First received: July 12, 2017
• Last updated: July 21, 2017
• Start date: August 1, 2017
• Est. completion date: July 30, 2020

Study information

• Verified date: June 2017
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Ma Juan, MD
• Phone: 13508300283
• Email: 476679422[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Nasal Continuous Positive Airway Pressure
• Nasal Intermittent Positive Pressure Ventilation
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
China	Department of Pediatrics, Daping Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (13)

Lead Sponsor

Collaborator

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Chengdu Women's and Children's Central Hospital, Children's Hospital of Chongqing Medical University, Children's Hospital of Fudan University, Chongqing Maternal and Child Health Hospital, Guangdong Women and Children Hospital, Guiyang Maternity and Child Health Care Hospital, Jiulongpo No.1 People's Hospital, Kunming Children's Hospital, Nanjing Children's Hospital, Shanxi Provincial Maternity and Children's Hospital, The Children's Hospital of Zhejiang University School of Medicine, Yan'an Affiliated Hospital of Kunming Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intubation rate	the infant is intubated ventilation	within 7 days
Secondary	Intraventricular hemorrhage	the incidence of intraventricular hemorrhage	within 28 days
Secondary	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
Secondary	Bayley Scales of Infant Development	scores of Bayley Scales of Infant Development	at 2 months old and 2 years old
Secondary	Neonatal necrotizing enterocolitis(NEC)	the incidence of neonatal necrotizing enterocolitis(>stage II);for NEC, Bell staging will be used	within 7 days