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

NCT ID: NCT03235661

Last Updated: 2021-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-15
• Study Completion Date: 2022-12-15

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.

Conditions

nCPAP; BiPAP; Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BiPAP

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

Group Type: EXPERIMENTAL

BiPAP

Intervention Type: DEVICE

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

Group Type: ACTIVE_COMPARATOR

nCPAP

Intervention Type: DEVICE

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

Interventions

BiPAP

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

Intervention Type: DEVICE

nCPAP

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Minutes
• Maximum Eligible Age: 6 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Ma Juan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shi Yuan, PhD,MD

Role: STUDY_DIRECTOR

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

Locations

Department of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ma Juan, MD

Role: CONTACT

476679422@qq.com

13883559467 ext. 86

Ma Juan, MD

Role: CONTACT

476679422@qq.com

1388.559467 ext. 86

Facility Contacts

Juan Ma, physician

Role: primary

zoe330@163.com

18680887330

Other Identifiers

twins with BiPAP

Identifier Type: -

Identifier Source: org_study_id