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Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS)

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ClinicalTrials.gov Identifier: NCT03217162
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : September 25, 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:
Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of surfactant is not clear. This study aimed to determine whether ARDS neonate would benefit from surfactant when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.

Condition or disease Intervention/treatment Phase
ARDS Drug: surfactant combined with mechanical ventilation (MV) Drug: mechanical ventilation (MV) Not Applicable

Detailed Description:
Acute respiratory distress syndrome (ARDS) can result in severe hypoxemia refractory to mechanical ventilation, mechanical ventilation including high frequency oscillation ventilation is the main method. But it is partial unuseful.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS): A Randomized Controlled Trial
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 30, 2021


Arm Intervention/treatment
Experimental: surfactant combined with mechanical ventilation
surfactant is given to the infant with ARDS.
Drug: surfactant combined with mechanical ventilation (MV)
surfactant combined with mechanical ventilation (MV) is given to the infant with ARDS

Active Comparator: mechanical ventilation
mechanical ventilation is given to the infant with ARDS.
Drug: mechanical ventilation (MV)
mechanical ventilation (MV) is given to the infant with ARDS




Primary Outcome Measures :
  1. death [ Time Frame: within 100 days ]
    death


Secondary Outcome Measures :
  1. Bayley Scales of Infant Development [ Time Frame: at 2 months old and 2 years old ]
    the survival are assessed by Bayley Scales of Infant Development



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. infant less than 28 days
  2. diagnosis of ARDS
  3. informed parental consent has been obtained

Exclusion Criteria:

  1. major congenital malformations or complex congenital heart disease
  2. 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): NCT03217162


Contacts
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Contact: Ma Juan, MD 13883559467 476679422@qq.com
Contact: Ma Juan, MD 1388.559467 476679422@qq.com

Locations
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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
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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, Principal Investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier: NCT03217162     History of Changes
Other Study ID Numbers: surfactant for ARDS
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury
Pulmonary Surfactants
Respiratory System Agents