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

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University300 enrolled

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

300

Conditions

nCPAP BiPAP Respiratory Distress Syndrome

Interventions

BiPAPDEVICE

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

nCPAPDEVICE

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

Eligibility

Sex: ALLMin age: 5 MinutesMax age: 6 Hours

Medical Language ↔ Plain English

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.

Locations (1)

Department of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

intubation rate

the baby was intubated

Time frame: within 7 days

Central Contacts

Ma Juan, MD

CONTACT

13883559467 476679422@qq.com

Ma Juan, MD

CONTACT

1388.559467 476679422@qq.com

Data from ClinicalTrials.gov

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