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

Overview

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 Title of Study: “Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins:A Randomized Controlled Trials”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 15, 2022

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.

Interventions

  • Device: BiPAP
    • BiPAP is used as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome
  • Device: nCPAP
    • nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome

Arms, Groups and Cohorts

  • Experimental: BiPAP
    • BiPAP as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome
  • Active Comparator: nCPAP
    • nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome

Clinical Trial Outcome Measures

Primary Measures

  • intubation rate
    • Time Frame: within 7 days
    • the baby was intubated

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 5 Minutes

Maximum Age: 6 Hours

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ma Juan, Principal Investigator – Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  • Overall Official(s)
    • Shi Yuan, PhD,MD, Study Director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  • Overall Contact(s)
    • Ma Juan, MD, 13883559467, 476679422@qq.com

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