Montelukast in Very Low Birthweight Infants

Completed · Phase 1

Conditions studied: Bronchopulmonary Dysplasia

In brief

The purpose of this study is to determine the pharmacokinetics (PK) of montelukast (Singulair) in very low birth weight (VLBW) infants at risk for developing bronchopulmonary dysplasia (the need for supplemental oxygen). The investigators' long-term hypothesis is that inhibition of leukotriene signaling in the VLBW preterm lung will decrease inflammation, remodeling and the incidence of bronchopulmonary dysplasia (BPD).

Key facts

Study ID

NCT00492102

Run by

Children's Hospital Medical Center, Cincinnati

People needed

9

Starts

2007-03-01

Expected to finish

2011-06-01

Last updated by the study team

2012-08-02

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• VLBW infants between 500 - 1500 gm birth-weight born at Good Samaritan Hospital, Cincinnati, tolerating oral feeds equal to or more than 75 ml/kg/day and older than 7 days

You may not qualify if…

• Infants diagnosed with congenital malformations.
• Infants with an acute life threatening illness.
• Grade III or IV intra-ventricular hemorrhage.
• Patent ductus arteriosus being treated with indomethacin.
• Oral feedings are contra-indicated.
• Parents refuse consent.
• Attending physician does not wish the infant to be enrolled in the study.
• Infants with known hepatitis or HIV.
• Infants enrolled in any study using an investigational drug.

Where it is running

• Good Samaritan Hospital — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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