Health Trials

Metformin for Premature Infants With Bronchopulmonary Dysplasia

ConditionBronchopulmonary Dysplasia (BPD)
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age7-6
SponsorMedical College of Wisconsin

About this trial

The overall objective of this study is to investigate the role of metformin in decreasing lung injury and promoting lung growth in premature infants. There are two phases to this pilot study. For Phase 0, the goal is to investigate the safety and tolerance of oral metformin in premature who have been diagnosed with bronchopulmonary dysplasia (BPD) at 36-44 weeks gestation. For Phase 1, the goal is to investigate metformin safety and tolerance in extremely premature infants who are 7-30 days old who have an increased risk of BPD. The main questions it aims to answer are:

* how well do older premature infants tolerate metformin? * how well do younger premature infants tolerate metformin?

Eligibility criteria

Qualifiers

Birth gestational age of < 29 weeks AND

Postnatal age between 8 and 22 weeks AND

Diagnosed with BPD at 36 weeks postnatal age

Birth gestational age of < 29 weeks, AND

Disqualifiers

Persistent hypoglycemia

Lactic acidosis

Feeding intolerance

Renal or hepatic dysfunction

Trial design

Treatments tested in this trial

  • Metformin (open-label)
  • Metformin (open-label)
  • Metformin (open-label)
  • Metformin (open-label)
  • Metformin (open-label)
  • Metformin (open-label)
  • Metformin (open-label)
  • Metformin (open-label)
  • Metformin (open-label)

Treatment groups

40 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Sponsors and collaborators

Medical College of Wisconsin

Lead sponsor

Source ClinicalTrials.gov