PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia

Launched by DUKE UNIVERSITY · Jul 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and how the medicine montelukast behaves in the bodies of very premature infants who are critically ill and at risk of developing a lung condition called Bronchopulmonary Dysplasia (BPD). BPD is a serious problem that can affect babies born too early and can make it hard for them to breathe. The study aims to find out how much montelukast the babies’ bodies absorb, how quickly the medicine works, and whether it is safe to use in this vulnerable group.

Babies who might be eligible for this study are those born before 28 weeks of pregnancy, weighing less than 1000 grams (about 2.2 pounds) at birth, and who are between 7 and 28 days old when they start the study. They must be receiving breathing support through a machine and need extra oxygen. Parents or guardians will need to give permission for their baby to join. During the study, participants will receive a carefully controlled dose of montelukast, starting with the lowest dose expected to help. The goal is to learn more about using this medicine safely to support babies with developing lung problems. Babies with certain health issues, previous montelukast treatment, or serious complications will not be included to ensure safety. This study is not yet open for enrollment but aims to improve future care for fragile premature infants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Documented informed consent from parent or guardian, prior to study activities
• • 2. Receiving mechanical ventilation \[high frequency or conventional\] and requiring supplemental oxygen (FiO2 ≥ 30%) at time of randomization
• • 3. \<28 weeks' gestational age and \<1000 g bodyweight at birth
• • 4. 7 to 28 (inclusive) days postnatal age at the time of first study drug dose
• • 5. Able to tolerate 5 mL of enteral volume
• Exclusion Criteria:
• • 1. Previous enrollment and dosing in the current PRISM study (NICHD-2023-MON01)
• • 2. Previous exposure to montelukast within 7 days prior to randomization
• • 3. Known allergy to montelukast
• • 4. Has a disease complication that would preclude safe participation of the subject
• • 5. 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.
• • 6. Congenital lung and diaphragmatic malformations.