Trial · NCT07101640
PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia
NCT07101640, Phase 1, Phase 2, Recruiting, Duke University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia. Trials, record NCT07101640. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07101640
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia
- NCT number
- NCT07101640
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 28 participants, estimated
- Lead sponsor
- Duke University
- Conditions
- Bronchopulmonary Dysplasia (BPD), Premature Births, Critical Illness
- Interventions
- montelukast 4 mg granule, Placebo
- First posted
- 2025-08-03
- Last updated
- 2026-07-14
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Apparent clearance (CL/F) of montelukast | From enrollment to 14 days post first dose. | The elimination of montelukast divided by the concentration of montelukast. |
| Secondary | Volume of distribution | From first dose of study drug though 7 days post last dose. | The total amount of montelukast in the body to the concentration in the bloodstream. |
| Secondary | Half-life | From first dose of study drug though 7 days post last dose. | The time that it takes for the concentration of montelukast in blood plasma to reach one-half of its steady-state value (the "plasma half-life"). |
| Secondary | Area Under Curve (AUC) | From first dose of study drug though 7 days post last dose. | The concentration of montelukast in blood plasma as a function of time. |
| Secondary | Maximum Concentration (Cmax) | From first dose of study drug though 7 days post last dose. | The maximum (or peak) serum concentration that montelukast achieves in a specified compartment or test area of the body after the drug has been administered and before the administration of a second dose. |
| Secondary | Death- Safety | From 30 days post treatment or 36 weeks PMA, whichever is longer; through 24 months of follow-up. | All infants who die at or before 30 days post treatment or 36 weeks PMA, whichever is longer, will be enumerated by treatment group. Researchers will also summarize by treatment group the percent and cumulative incidence of deaths through 24 months of follow-up. |
| Secondary | Serious Adverse Events | At or before 30 days post treatment or 36 weeks PMA, whichever is longer. | Total SAEs by participants. Researchers will determine the incidence (rate per person-time) and prevalence (percent of each treatment group experiencing an SAE) at or before 30 days post treatment or 36 weeks PMA, whichever is longer. |
| Secondary | Total Neuropsychiatric Adverse Events (NPAE) | From first dose to 30 days post treatment or 36-weeks PMA, whichever is longer. | Researchers will collect safety events of special interest: neuropsychiatric events, including irritability, sedation, apnea, convulsion/seizure, sleep disturbance, tremor and neuropsychiatric event (other). 'Other' will be any event not fitting the previous categories but deemed to be neuropsychiatric in nature by the site principal investigator (PI). For total NPAEs, researchers will determine the incidence (rate per person-time) and prevalence (percent of each treatment arm experiencing an NPAE) for each treatment group. For all safety events researchers will calculate the incidence and prevalence for both the treatment period and for the period to 30 days post treatment or 36-weeks PMA, whichever is longer. Site investigators will determine seriousness and severity for all AEs. |
| Secondary | Neonatal Infections | From first dose till at or before 30 days post treatment or 36 weeks PMA, whichever is longer. | Researchers will determine the prevalence (percent of each treatment group experiencing an infectious adverse event) at or before 30 days post treatment or 36 weeks PMA, whichever is longer. Specific infections will include (but not limited to): upper respiratory infections, pharyngitis, sinusitis, and otitis. |
| Secondary | Neurodevelopmental outcomes (Bayley-4) | From first dose through 24 months of age. | The Bayley Scales of Infant and Toddler Development, Fourth Edition, (often referred to as the Bayley-4) will be completed by a site-based specialist at 24 months of age (range 22 to 26 months). The Bayley-4 is a standardized assessment tool designed to evaluate the developmental functioning of infants and toddlers. Composite scores for each domain are standardized, with a mean of 100 and a standard deviation of 15. Composite scores are also converted into percentile ranks, which indicate the child's performance relative to a normative sample. For instance, a percentile rank of 50 means the child is performing at the average level for their age group. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HD113201 | PRISM | LANG, JASON E.; GONZALEZ, DANIEL; LAUGHON, MATTHEW | DUKE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2023 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07101640
GET https://conductscience.org/api/trials/v1/NCT07101640/registered