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Nasal Intermittent Positive-Pressure Ventilation for Twin Infants With Respiratory Distress Syndrome

Not Applicable
Completed
Conditions
Neonatal Respiratory Distress Syndrome
Interventions
Device: nIPPV
Device: nCPAP
Registration Number
NCT01926106
Lead Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Brief Summary

In the present study, we hypothesized that primary mode nIPPV initiated shortly after birth would decrease the incidence of intubation or death in twin infants when compared to nCPAP.

Detailed Description

After inclusion of eligible twins infants,one of the twins was supported by nCPAP and another nIPPV.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
286
Inclusion Criteria
  • Twins
  • Clinical diagnosis of mild-moderate respiratory distress syndrome
  • requiring a fraction of inspired oxigen (FiO2 ) <0.40 to keep oxygen saturation of 90%-95%
  • a chest X-ray suggestive of early stage hyaline membrane disease, (i.e. mild microgranulia and air bronchogram)
Exclusion Criteria
  • pneumothorax
  • pneumomediastinum
  • surgical diseases
  • cardiac diseases
  • intraventricular hemorrage
  • major congenital defects

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
nIPPVnIPPVthe infants in the arm were supported by Nasal Intermittent Positive-Pressure Ventilation(nIPPV)
nCPAPnCPAPthe infants in the arm were supported by Nasal Continuous Positive Airway Pressure(nCPAP)
Primary Outcome Measures
NameTimeMethod
incidence of intubation48h
Secondary Outcome Measures
NameTimeMethod
incidence of BPD1 month

Trial Locations

Locations (1)

Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University

🇨🇳

Chongqing, Chongqing, China

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