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

Army Medical University of People's Liberation Army

Status: Completed

Conditions: Neonatal Respiratory Distress Syndrome

Treatments: Device: nIPPV; Device: nCPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01926106

twins

Details and patient eligibility

About

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.

Full description

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

Enrollment: 286 patients

Sex: All

Ages: 30 minutes to 6 hours old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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286 participants in 2 patient groups

nIPPV

Experimental group

Description:

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

Treatment:

Device: nIPPV

nCPAP

Active Comparator group

Description:

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

Treatment:

Device: nCPAP