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

December 6, 2017 updated by: Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

286

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 minutes to 6 hours (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • nCPAP:Nasal Continuous Positive Airway Pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of intubation
Time Frame: 48h
48h

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of BPD
Time Frame: 1 month
1 month

Other Outcome Measures

Outcome Measure
Time Frame
death
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2012

Primary Completion (Actual)

July 30, 2017

Study Completion (Actual)

July 30, 2017

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (Estimate)

August 20, 2013

Study Record Updates

Last Update Posted (Actual)

December 7, 2017

Last Update Submitted That Met QC Criteria

December 6, 2017

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TWINS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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