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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01926106
Acronym
twins
Enrollment
286
Registered
2013-08-20
Start date
2012-07-01
Completion date
2017-07-30
Last updated
2017-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Respiratory Distress Syndrome

Keywords

Nasal Intermittent Positive-Pressure Ventilation, Nasal Continuous Positive Airway Pressure, twin, respiratory distress syndrome

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.

Interventions

DEVICEnIPPV

one of the twins was randomly allocated to nIPPV

DEVICEnCPAP

another of the twins was allocated to nCPAP

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Minutes to 6 Hours
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
incidence of intubation48h

Secondary

MeasureTime frame
incidence of BPD1 month

Other

MeasureTime frame
death3 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026