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

Primary Purpose

nCPAP, BiPAP, Respiratory Distress Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
BiPAP
nCPAP
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for nCPAP

Eligibility Criteria

5 Minutes - 6 Hours (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Pediatrics, Daping Hospital, Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BiPAP

nCPAP

Arm Description

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

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

Outcomes

Primary Outcome Measures

intubation rate
the baby was intubated

Secondary Outcome Measures

Full Information

First Posted
July 28, 2017
Last Updated
February 14, 2021
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03235661
Brief Title
Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins Infants
Official Title
Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins:A Randomized Controlled Trials
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
nCPAP, BiPAP, Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
BiPAP and nCPAP are used as primary mode of ventilation in preterm twins infants with RDS
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BiPAP
Arm Type
Experimental
Arm Description
BiPAP as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome
Arm Title
nCPAP
Arm Type
Active Comparator
Arm Description
nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome
Intervention Type
Device
Intervention Name(s)
BiPAP
Intervention Description
BiPAP is used as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome
Intervention Type
Device
Intervention Name(s)
nCPAP
Intervention Description
nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome
Primary Outcome Measure Information:
Title
intubation rate
Description
the baby was intubated
Time Frame
within 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Minutes
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ma Juan, MD
Phone
13883559467
Ext
86
Email
476679422@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ma Juan, MD
Phone
1388.559467
Ext
86
Email
476679422@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi Yuan, PhD,MD
Organizational Affiliation
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Pediatrics, Daping Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Ma, physician
Phone
18680887330
Email
zoe330@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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