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Tests treatment safety and results for Bronchopulmonary Dysplasia (BPD)
Official title PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia
ClinicalTrials.gov ID: NCT07101640
What this study is testing
What is montelukast 4 mg granule?
montelukast 4 mg granule is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for bronchopulmonary dysplasia (bpd).
Also referred to as montelukast sodium.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of the study is to learn how safe montelukast may be in premature infants at significant risk for Bronchopulmonary Dysplasia (BPD) and to determine how much and how quickly montelukast moves from the stomach into the bloodstream, and how quickly it is removed from the bloodstream. Data supporting the prospect of montelukast benefit involved 6 previous studies involving 206 preterm infants.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 28
You may be able to join if
- Documented informed consent from parent or guardian, prior to study activities
- Receiving mechanical ventilation [high frequency or conventional] and requiring supplemental oxygen (FiO2 ≥ 30%) at time of randomization
- \<28 weeks' gestational age and \<1000 g bodyweight at birth
- 7 to 28 (inclusive) days postnatal age at the time of first study drug dose
- Able to tolerate 5 mL of enteral volume
You likely can't join if
- Previous enrollment and dosing in the current PRISM study (NICHD-2023-MON01)
- Previous exposure to montelukast within 7 days prior to randomization
- Known allergy to montelukast
- PI deems infant - prior to enrollment - is not expected to survive
- Has a disease complication that would preclude safe participation of the participant
- Increased respiratory support due to intercurrent illness (e.g., sepsis, necrotizing enterocolitis, etc.). Infants should be excluded from the study...
See the full eligibility criteria
- Documented informed consent from parent or guardian, prior to study activities
- Receiving mechanical ventilation [high frequency or conventional] and requiring supplemental oxygen (FiO2 ≥ 30%) at time of randomization
- \<28 weeks' gestational age and \<1000 g bodyweight at birth
- 7 to 28 (inclusive) days postnatal age at the time of first study drug dose
- Able to tolerate 5 mL of enteral volume
- Previous enrollment and dosing in the current PRISM study (NICHD-2023-MON01)
- Previous exposure to montelukast within 7 days prior to randomization
- Known allergy to montelukast
- PI deems infant - prior to enrollment - is not expected to survive
- Has a disease complication that would preclude safe participation of the participant
- Increased respiratory support due to intercurrent illness (e.g., sepsis, necrotizing enterocolitis, etc.). Infants should be excluded from the study until after resolution of the acute event
- Congenital lung and diaphragmatic malformations
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Amherst, Massachusetts, United States
- Las Vegas, Nevada, United States
- Chapel Hill, North Carolina, United States
- Greenville, North Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 days to 28 days. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Amherst, Massachusetts, United States; Las Vegas, Nevada, United States; Chapel Hill, North Carolina, United States; Greenville, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.