Intra-tracheal Instillation of Budesonide to Prevent Chronic Lung Disease
STOPCLD
1 other identifier
interventional
25
1 country
1
Brief Summary
Preterm infants are randomized to received either Intra-tracheal instillation of budesonide using surfactant as vehicle or a placebo. Intra-tracheal instillation of budesonide using surfactant as vehicle would facilitate its delivery to the periphery of the lung and would inhibit lung inflammation and mitigate acute lung injury.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2019
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 2, 2019
CompletedFirst Submitted
Initial submission to the registry
May 2, 2022
CompletedFirst Posted
Study publicly available on registry
May 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedNovember 1, 2022
October 1, 2022
3.2 years
May 2, 2022
October 31, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change of combined inflammatory cytokines
Change in inflammatory cytokines /chemokines (interleukin-6, 8, 10 and Tumor Necrosis Factor α (TNF-α) levels
4 weeks
Secondary Outcomes (4)
chronic lung disease
36 weeks corrected gestational age (CGA)
Mortality
upto 40 weeks corrected gestational age (CGA)
Ventilator days
Upto 40 weeks corrected gestational age (CGA)
Neuro-developmental outcome
18 - 26 months corrected postnatal age
Study Arms (2)
S/B group- infants
EXPERIMENTALInfants randomized to the study group (S/B group) will receive surfactant and Budesonide - 0.5 mg -1mL
S/P group- control / placebo comparator
PLACEBO COMPARATORInfants randomized to the control group (S/P group) will receive surfactant and placebo (Normal Saline -1mL)
Interventions
Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL)
Infants in the control group (S/P group) will receive surfactant 2.5 mls/kg and placebo (Normal saline 1mL)
Eligibility Criteria
You may qualify if:
- Infants born at \< 30+0/7 weeks (23+0 - 29+6/7) gestational age (GA) OR with preterm infants with a birth weight (BW) which is \< 1500 gm AND if they have severe respiratory distress syndrome (RDS) (Clinical diagnosis based on the need for mechanical ventilation in preterm infant or if they have radiologic features of RDS along with need for positive distending airway pressure and fractional inspired oxygen (FiO2) \> 0.3)
You may not qualify if:
- major congenital defects
- chromosomal abnormality
- pneumothorax
- Known surgical disease
- Known or suspected congenital heart disease
- Infant not considered viable by physician
- Severe sepsis / infections
- Likely to be extubated within the next 24 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arizona
Tucson, Arizona, 85719, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2022
First Posted
May 6, 2022
Study Start
December 2, 2019
Primary Completion
February 1, 2023
Study Completion
December 1, 2024
Last Updated
November 1, 2022
Record last verified: 2022-10