Inhaled Tobramycin in BPD

Inclusion criteria

• Male or female infants born <32 weeks' gestation
• Diagnosed with BPD (use of supplemental oxygen or respiratory support at 36 weeks postmenstrual age )
• Postmenstrual age ≥36 weeks at study enrollment
• Treatment with invasive mechanical ventilation at enrollment without planned tracheal extubation within 7 days after enrollment
• Tracheal aspirate culture positive for one of the following pathogenic GNR bacteria within 7 days prior to enrollment: Pseudomonas aeruginosa, Klebsiella species, Enterobacter species, Stenotrophomonas maltophilia, Escherichia coli, Acinetobacter baumannii, or Serratia marcescens
• Parental/guardian permission (informed consent).

Exclusion criteria

• Serum creatinine >0.4mg/dL within 14 days prior to enrollment
• Congenital or acquired disease of the kidney or renal collecting system that adversely affects renal function
• Congenital or acquired hepatobiliary disease that adversely affects liver function
• Treatment with a systemic antibiotic within 7 days prior to enrollment
• Treatment with a nephrotoxic medication, excluding diuretics, within 48 hours prior to enrollment
• Treatment with a neuromuscular blocker within 48 hours prior to enrollment
• Known intolerance to aminoglycoside antibiotics
• Current treatment with high frequency or other oscillating mechanical ventilation
• Presence of a cancer diagnosis
• Maternal family history of early onset hearing loss defined as the need for an assistive hearing device prescribed before 30 years of age
• Endotracheal tube leak >20%.
• Any prior use of an investigational drug [as part of an FDA approved Investigational New Drug (IND) protocol].
• A subject who, in the judgement of the Investigator, is not an appropriate candidate for this research study.