Trial record 11 of 22 for:    Open Studies | "Twins"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor:
Information provided by (Responsible Party):
Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01926106
First received: August 8, 2013
Last updated: August 19, 2013
Last verified: August 2013
  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: Double Blind (Subject, Caregiver, 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

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

Primary Outcome Measures:
  • incidence of intubation [ Time Frame: 48h ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • incidence of BPD [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • death [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 64
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (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

Ages Eligible for Study:   up to 6 Hours
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926106

Contacts
Contact: Long Chen, MD 8613883559467 neuroclong@126.com

Locations
China, Chongqing
Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Long Chen, MD    8613883559467    neuroclong@126.com   
Principal Investigator: Long Chen, MD         
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

No publications provided

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
Study First Received: August 8, 2013
Last Updated: August 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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:
Respiratory Distress Syndrome, Newborn
Hyaline Membrane Disease
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 22, 2014