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

Neonatal Respiratory Distress Syndrome Clinical Trial

— twins  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926106
• Other study ID #: twins
• 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
• 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

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• Neonatal Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

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