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Intratracheal Budesonide/Surfactant Prevents BPD

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ClinicalTrials.gov Identifier: NCT03275415
Recruitment Status : Not yet recruiting
First Posted : September 7, 2017
Last Update Posted : September 12, 2018
Sponsor:
Collaborators:
Taipei Medical University Hospital
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
Mackay Memorial Hospital
Chung Shan Medical University
Chang Gung Memorial Hospital
China Medical University Hospital
Information provided by (Responsible Party):
Taipei Medical University

Brief Summary:
A double-blind study includes: 1) birth Wt 500-1499 gm, 2) respiratory distress shortly after birth and requires resuscitation 3) failure to NCPAP within 4 hrs after birth, defined as: a) FIO2 ≥ 0.30, pressure > 5cmH2O b) severe retraction c) apnea d) PCO2 ≥ 60 mmHg. Exclusion criteria: 1) lethal cardiopulmonary status 2) severe congenital anomalies. Sample size will be determined based on a one-third (33%) improvement of the current incidence of BPD or death in the selected population (from 50%→33%), allowing a type I error 0.05, type II error 0.10 (power 0.90), 182 infants in each group would be needed and 190 in each group would be a safe target number. The infants will be randomly assigned to control (C) (Curosurf/placebo) or intervention (I) (Curosurf/budesonide); given q. 12 hrs for a maximum of 3 doses unless the infant is extubated or require FIO2 <30%. Appropriate amount of placebo will be used as it does not affect the biophysical property of curosurf (PAS abstract 2017 San Francisco) Primary outcome of study is death or BPD defined by NICHD criteria. Follow up study of neuromotor and cognitive function and pulmonary states will be done at 1-2 years of corrected age.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Bronchopulmonary Dysplasia Drug: budesonide Drug: Saline Phase 4

Detailed Description:
A double-blind study will be conducted in 7 tertiary centers. Inclusion criteria are: 1) birth Wt 500-1499 gm, 2) respiratory distress shortly after birth and requires resuscitation 3) failure to NCPAP within 4 hrs after birth, defined as: a) FIO2 ≥ 0.30, pressure > 5cmH2O b) severe retraction c) apnea d) PCO2 ≥ 60 mmHg. Exclusion criteria: 1) lethal cardiopulmonary status 2) severe congenital anomalies. Sample size will be determined based on a one-third (33%) improvement of the current incidence of BPD or death in the selected population (from 50%→33%), allowing a type I error 0.05, type II error 0.10 (power 0.90), 182 infants in each group would be needed and 190 in each group would be a safe target number. The infants will be randomly assigned to control (C) (Curosurf/placebo) or intervention (I) (Curosurf/budesonide); given q. 12 hrs for a maximum of 3 doses unless the infant is extubated or require FIO2 <30%. Appropriate amount of placebo will be used as it does not affect the biophysical property of curosurf (PAS abstract 2017 San Francisco) Primary outcome of study is death or BPD defined by NICHD criteria. Follow up study of neuromotor and cognitive function and pulmonary states will be done at 1-2 years of corrected age.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a double blind randomized trial. The infants will be randomly assigned into 2 groups: Control (C) (curosurf + saline) and Intervention (I) (curosurf+ budesonide).
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: This is a double blind randomized trial. The infants will be randomly assigned into 2 groups: Control (C) (curosurf + saline) and Intervention (I) (curosurf+ budesonide).
Primary Purpose: Prevention
Official Title: Routine Administration of Surfactant/Budesonide to Prevent BPD in VLBW With RDS-A Double Blind Study
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020


Arm Intervention/treatment
Active Comparator: Experimental
Curosurf + budesonide
Drug: budesonide
Intra-tracheal instillation of a combination of budesonide/surfactant in preterm infants with RDS to prevent BPD
Other Name: pulmicort

Placebo Comparator: Placebo
Curosurf + saline
Drug: Saline
Intra-tracheal instillation of a combination of saline/surfactant in preterm infants with RDS to prevent BPD
Other Name: sodium chloride




Primary Outcome Measures :
  1. incidence of death or BPD [ Time Frame: 6 months ]
    Primary outcome of study is death or BPD defined by NICHD criteria.



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Ages Eligible for Study:   up to 4 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) birth Wt 500-1499 gm, 2) respiratory distress shortly after birth and requires resuscitation, 3) failure to NCPAP within 4 hrs after birth, defined as: a) FIO2 ≥ 0.30, pressure > 5 cmH2O b) severe retraction c) apnea d) PCO2 ≥ 60 mmHg.

Exclusion Criteria:

  • 1) lethal cardiopulmonary status, 2) severe congenital anomalies.

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): NCT03275415


Contacts
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Contact: Tsu F Yeh, M.D., Ph.D. 886-2-27361661 ext 7213 tfyeh@mail.ncku.edu.tw
Contact: Chung M. Chen, MD., PhD. 886-2-27372181 ext 3715 cmchen@tmu.edu.tw

Sponsors and Collaborators
Taipei Medical University
Taipei Medical University Hospital
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
Mackay Memorial Hospital
Chung Shan Medical University
Chang Gung Memorial Hospital
China Medical University Hospital
Investigators
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Principal Investigator: Tsu F Yeh, M.D., Ph.D. Maternal Child Health Research Center, Taipei Medical University

Publications of Results:
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Responsible Party: Taipei Medical University
ClinicalTrials.gov Identifier: NCT03275415     History of Changes
Other Study ID Numbers: N201705026
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
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
Keywords provided by Taipei Medical University:
BPD
surfactant
budesonide
respiratory distress syndrome
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Bronchopulmonary Dysplasia
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Ventilator-Induced Lung Injury
Lung Injury
Budesonide
Pulmonary Surfactants
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists