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

February 14, 2021 updated by: Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • Department of Pediatrics, Daping Hospital, Third Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 minutes to 6 hours (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BiPAP
BiPAP as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome
Device: BiPAP
BiPAP is used 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
Device: nCPAP
nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intubation rate
Time Frame: within 7 days
the baby was intubated
within 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2017

Primary Completion (Anticipated)

December 15, 2022

Study Completion (Anticipated)

December 15, 2022

Study Registration Dates

First Submitted

July 28, 2017

First Submitted That Met QC Criteria

July 28, 2017

First Posted (Actual)

August 1, 2017

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 14, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • twins with BiPAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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