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Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Twins Infants

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ClinicalTrials.gov Identifier: NCT03206489
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : July 22, 2019
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 —noninvasive high-frequency oscillatory ventilation (nHFOV) 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
Nasal High Frequency Oscillation Ventilation Device: noninvasive high-frequency ventilation (nHFOV) Device: nasal continuous positive airway pressure (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 noninvasive high frequency oscillatory ventilation (NHFOV) and nasal continuous positive airway pressure (NCPAP) in preterm twins infants as the primary mode.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: noninvasive high-frequency ventilation (nHFOV) and nasal continuous positive airway pressure (nCPAP) are used as primary mode of ventilation in preterm twins infants with RDS
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Preterm Twins Infants
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022


Arm Intervention/treatment
Experimental: nHFOV
noninvasive high-frequency ventilation (nHFOV) is used as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome
Device: noninvasive high-frequency ventilation (nHFOV)
noninvasive high-frequency ventilation (nHFOV) as a primary mode of ventilation in one of the preterm twins infants with respiratory distress syndrome

Active Comparator: nCPAP
nasal continuous positive airway pressure (nCPAP) is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome
Device: nasal continuous positive airway pressure (nCPAP)
nasal continuous positive airway pressure (nCPAP) as a primary mode of ventilation in another of the preterm twins infants with respiratory distress syndrome




Primary Outcome Measures :
  1. intubation [ Time Frame: during the first 7 days after birth ]
    the baby is re-intubated.


Secondary Outcome Measures :
  1. Bronchopulmonary dysplasia(BPD) [ Time Frame: at a post-menstrual age of 36 weeks or at discharge ]
    BPD was defined according to the National Institutes of Health consensus definition

  2. Bayley Scales of Infant Development [ Time Frame: 30 months after birth ]
    scores of Bayley Scales of Infant Development at 2 months old and 2 years old



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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 resuscitation7;
  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): NCT03206489


Contacts
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Contact: Chen Long, MD 13883559467 ext 86 476679422@qq.com

Locations
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China, Chongqing
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Chen Long, PhD,MD    13508300283    petshi530@vip.163.com   
Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Investigators
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Study Director: Shi Yuan, PhD,MD Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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Responsible Party: Ma Juan, director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier: NCT03206489     History of Changes
Other Study ID Numbers: twins with HFO
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases