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

Not Applicable

• Conditions: Respiratory Distress Syndrome; nCPAP; BiPAP
• Interventions: Device: nCPAP; Device: BiPAP

• Registration Number: NCT03235661
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-07-28
• Study First Submitted QC: 2017-07-28
• Study First Posted: 2017-08-01
• Study Start: 2017-08-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-14
• Last Update Posted: 2021-02-16
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nCPAP	nCPAP	nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome
BiPAP	BiPAP	BiPAP as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome

Primary Outcome Measures

Name	Time	Method
intubation rate	within 7 days	the baby was intubated

Trial Locations

Locations (1)

Department of Pediatrics, Daping Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China