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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01926106
Other study ID # twins
Secondary ID
Status Completed
Phase N/A
First received August 8, 2013
Last updated December 6, 2017
Start date July 1, 2012
Est. completion date July 30, 2017

Study information

Verified date August 2013
Source Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 286
Est. completion date July 30, 2017
Est. primary completion date July 30, 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Hours
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
nIPPV
one of the twins was randomly allocated to nIPPV
nCPAP
another of the twins was allocated to nCPAP

Locations

Country Name City State
China Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other death 3 months
Primary incidence of intubation 48h
Secondary incidence of BPD 1 month
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