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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01926106
First Posted: August 20, 2013
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  Purpose
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.

Condition Intervention
Neonatal Respiratory Distress Syndrome Device: nIPPV Device: nCPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Nasal Intermittent Positive-Pressure Ventilation vs Nasal Continuous Positive Airway Pressure for Twin Infants With Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University:

Primary Outcome Measures:
  • incidence of intubation [ Time Frame: 48h ]

Secondary Outcome Measures:
  • incidence of BPD [ Time Frame: 1 month ]

Other Outcome Measures:
  • death [ Time Frame: 3 months ]

Enrollment: 286
Actual Study Start Date: July 1, 2012
Study Completion Date: July 30, 2017
Primary Completion Date: July 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nIPPV
the infants in the arm were supported by Nasal Intermittent Positive-Pressure Ventilation(nIPPV)
Device: nIPPV
one of the twins was randomly allocated to nIPPV
Other Name: nIPPV:Nasal Intermittent Positive Pressure Ventilation
Active Comparator: nCPAP
the infants in the arm were supported by Nasal Continuous Positive Airway Pressure(nCPAP)
Device: nCPAP
another of the twins was allocated to nCPAP
Other Name: nCPAP:Nasal Continuous Positive Airway Pressure

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926106


Locations
China, Chongqing
Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University
Chongqing, Chongqing, China, 400042
Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Investigators
Principal Investigator: Long Chen, MD Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University,
  More Information

Responsible Party: Chen Long,MD, Prof;MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier: NCT01926106     History of Changes
Other Study ID Numbers: twins
First Submitted: August 8, 2013
First Posted: August 20, 2013
Last Update Posted: December 7, 2017
Last Verified: August 2013

Keywords provided by Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University:
Nasal Intermittent Positive-Pressure Ventilation
Nasal Continuous Positive Airway Pressure
twin
respiratory distress syndrome

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Hyaline Membrane Disease
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases