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

Primary Purpose

Neonatal Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
nIPPV
nCPAP
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neonatal Respiratory Distress Syndrome focused on measuring Nasal Intermittent Positive-Pressure Ventilation, Nasal Continuous Positive Airway Pressure, twin, respiratory distress syndrome

Eligibility Criteria

30 Minutes - 6 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nIPPV

nCPAP

Arm Description

the infants in the arm were supported by Nasal Intermittent Positive-Pressure Ventilation(nIPPV)

the infants in the arm were supported by Nasal Continuous Positive Airway Pressure(nCPAP)

Outcomes

Primary Outcome Measures

incidence of intubation

Secondary Outcome Measures

incidence of BPD

Full Information

First Posted
August 8, 2013
Last Updated
December 6, 2017
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01926106
Brief Title
Nasal Intermittent Positive-Pressure Ventilation for Twin Infants With Respiratory Distress Syndrome
Acronym
twins
Official Title
Nasal Intermittent Positive-Pressure Ventilation vs Nasal Continuous Positive Airway Pressure for Twin Infants With Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 1, 2012 (Actual)
Primary Completion Date
July 30, 2017 (Actual)
Study Completion Date
July 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Respiratory Distress Syndrome
Keywords
Nasal Intermittent Positive-Pressure Ventilation, Nasal Continuous Positive Airway Pressure, twin, respiratory distress syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nIPPV
Arm Type
Experimental
Arm Description
the infants in the arm were supported by Nasal Intermittent Positive-Pressure Ventilation(nIPPV)
Arm Title
nCPAP
Arm Type
Active Comparator
Arm Description
the infants in the arm were supported by Nasal Continuous Positive Airway Pressure(nCPAP)
Intervention Type
Device
Intervention Name(s)
nIPPV
Other Intervention Name(s)
nIPPV:Nasal Intermittent Positive Pressure Ventilation
Intervention Description
one of the twins was randomly allocated to nIPPV
Intervention Type
Device
Intervention Name(s)
nCPAP
Other Intervention Name(s)
nCPAP:Nasal Continuous Positive Airway Pressure
Intervention Description
another of the twins was allocated to nCPAP
Primary Outcome Measure Information:
Title
incidence of intubation
Time Frame
48h
Secondary Outcome Measure Information:
Title
incidence of BPD
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
death
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Minutes
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Long Chen, MD
Organizational Affiliation
Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China

12. IPD Sharing Statement

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

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