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

Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03235661
• Other study ID #: twins with BiPAP
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2017
• Est. completion date: December 15, 2022

Study information

• Verified date: February 2021
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Ma Juan, MD
• Phone: 13883559467
• Email: 476679422[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Hours

Eligibility

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.

Related Conditions & MeSH terms

• BiPAP
• nCPAP
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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

Locations

Country	Name	City	State
China	Department of Pediatrics, Daping Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intubation rate	the baby was intubated	within 7 days