Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins Infants

Study Overview
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Brief Summary
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The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -bi-level positive airway pressure(BiPAP) or nasal continuous positive airway pressure (nCPAP) -as a primary mode of ventilation in preterm twins infants with respiratory distress syndrome

Detailed Description
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Invasive ventilation is related to development of adverse pulmonary and nonpulmonary outcomes in ventilated infants. Various modes of noninvasive respiratory support are being increasingly used to minimize the incidence of bronchopulmonary dysplasia (BPD). The aim of this trial to compare the effects of bi-level positive airway pressure(BiPAP) and nasal continuous positive airway pressure (NCPAP) in preterm twins infants as the primary mode.

Official Title
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Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins:A Randomized Controlled Trials

Conditions
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nCPAP, BiPAP, Respiratory Distress Syndrome

Intervention / Treatment
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* Device: BiPAP
* Device: nCPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Gestational age (GA) is from 26 to 37 weeks; 2. Diagnosis of respiratory distress syndrome. The diagnosis of respiratory distress syndrome will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings; 3. Respiratory distress syndrome Silverman score >5; 4. Informed parental consent has been obtained. Exclusion Criteria: 1. Severe respiratory distress syndrome requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation; 2. Major congenital malformations or complex congenital heart disease; 3. Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage; 4. Cardiopulmonary arrest needing prolonged resuscitation; 5. transferred out of the neonatal intensive care unit without treatment.

Ages Eligible for Study
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Minimum Age: 5 Minutes
Maximum Age: 6 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: BiPAP and nCPAP are used as primary mode of ventilation in preterm twins infants with RDS
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BiPAP<br>BiPAP as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome | Device: BiPAP<br>* BiPAP is used as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome<br>|
| Active Comparator: nCPAP<br>nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome | Device: nCPAP<br>* nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubation rate | the baby was intubated | within 7 days |