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

NCT03235661 | Unknown DMC

• 1 other identifier: twins with BiPAP
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

nCPAP; BiPAP; Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• intubation rate

  the baby was intubated

  within 7 days

Study Arms (2)

BiPAP

EXPERIMENTAL

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

Device: BiPAP

nCPAP

ACTIVE COMPARATOR

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

Device: nCPAP

Interventions

BiPAP DEVICE

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

BiPAP

nCPAP DEVICE

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

nCPAP

Eligibility Criteria

• Age: 5 Minutes - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Gestational age (GA) is from 26 to 37 weeks;
• \. 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;
• \. Respiratory distress syndrome Silverman score \>5;
• \. Informed parental consent has been obtained.

You may not qualify if:

• \. Severe respiratory distress syndrome requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation;
• \. Major congenital malformations or complex congenital heart disease;
• \. Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage;
• \. Cardiopulmonary arrest needing prolonged resuscitation;
• \. transferred out of the neonatal intensive care unit without treatment.

Sponsors & Collaborators

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

Study Sites (1)

Department of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Shi Yuan, PhD,MD

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

  STUDY DIRECTOR

Central Study Contacts

Ma Juan, MD

CONTACT

13883559467; 476679422@qq.com

Ma Juan, MD

CONTACT

1388.559467; 476679422@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: BiPAP and nCPAP are used as primary mode of ventilation in preterm twins infants with RDS

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 1, 2017
• Study Start: August 15, 2017
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

CN (1)