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

Army Medical University of People's Liberation Army

Status: Unknown

Conditions: Respiratory Distress Syndrome; BiPAP; nCPAP

Treatments: Device: nCPAP; Device: BiPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT03235661

twins with BiPAP

Details and patient eligibility

About

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

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 5 minutes to 6 hours old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups

BiPAP

Experimental group

Description:

BiPAP as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome

Treatment:

Device: BiPAP

nCPAP

Active Comparator group

Description:

nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome

Treatment:

Device: nCPAP