This study is looking at montelukast (a medication given as oral granules mixed with breast milk or formula) in critically ill premature infants who are at high risk of developing Bronchopulmonary Dysplasia (BPD), a serious lung condition. Researchers want to understand how safe montelukast is for these infants and how their bodies process the medication. The study will also look for early signs that montelukast might help improve breathing. You may be eligible if your infant is 7 to 28 days old, was born before 28 weeks of pregnancy, weighs less than 1000 grams, and needs breathing support. The study plans to enroll 28 infants. The current recruitment status is unclear.

Study design

This is a multi-center, prospective, randomized, double-blinded, placebo-controlled study involving 28 participants. Infants will receive either montelukast or a placebo (plain breast milk or formula) for 7 days.

What's involved

Your infant will receive the study drug for 7 days. Inpatient participation may last up to approximately 60 days, and outpatient follow-up assessments will occur at 6, 12, 18, and 24 months of age.

Compensation

Not stated in the trial record.

Follow-up

After the 7 days of treatment, infants will be monitored for safety for 30 days or until 36 weeks postmenstrual age, whichever is longer. They will also have medical and neurodevelopmental follow-up assessments until they are 24 months old.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.