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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03226977
Enrollment
1000
Registered
2017-07-24
Start date
2017-08-01
Completion date
2020-07-30
Last updated
2017-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Continuous Positive Airway Pressure, Nasal Intermittent Positive Pressure Ventilation

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.

Interventions

DEVICENIPPV

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

DEVICENCPAP

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Minutes to 6 Hours
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
intubation ratewithin 7 daysthe infant is intubated ventilation

Secondary

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

Countries

China

Contacts

Primary ContactMa Juan, MD
476679422@qq.com13508300283

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026