Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 37 of 199 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03235661
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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

Condition or disease Intervention/treatment Phase
nCPAP BiPAP Respiratory Distress Syndrome Device: BiPAP Device: nCPAP Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: BiPAP and nCPAP are used as primary mode of ventilation in preterm twins infants with RDS
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins:A Randomized Controlled Trials
Estimated Study Start Date : August 15, 2017
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : August 15, 2020


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




Primary Outcome Measures :
  1. intubation rate [ Time Frame: within 7 days ]
    the baby was intubated



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235661


Contacts
Layout table for location contacts
Contact: Ma Juan, MD 13883559467 ext 86 476679422@qq.com
Contact: Ma Juan, MD 1388.559467 ext 86 476679422@qq.com

Locations
Layout table for location information
China, Chongqing
Department of Pediatrics, Daping Hospital, Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Juan Ma, physician    18680887330    zoe330@163.com   
Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Investigators
Layout table for investigator information
Study Director: Shi Yuan, PhD,MD Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Layout table for additonal information
Responsible Party: Ma Juan, Principal Investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier: NCT03235661     History of Changes
Other Study ID Numbers: twins with BiPAP
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases