Metformin for Premature Infants With Bronchopulmonary Dysplasia

Medical College of Wisconsin

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Bronchopulmonary Dysplasia (BPD)

Treatments: Drug: Metformin (open-label)

Study type: Interventional

Funder types: Other

Identifiers

NCT07120971

PRO55881

Details and patient eligibility

About

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?

Full description

In Phase 0, there are four groups with different doses of metformin, starting at 5mg/kg/day to a maximum of 25mg/kg/day. Participants will take oral metformin twice a day for 3, 7 or 14 days, depending on which group they are in. In Phase 1, there are four groups with different doses of metformin, starting at 15mg/kg/day to a maximum of 25mg/kg/day. Participants will take oral metformin once a day for 3, 7, or 14 days, depending on what group they are in.

Enrollment: 40 estimated patients

Sex: All

Ages: 7 days to 6 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Phase 0:

• Birth gestational age of < 29 weeks AND
• Postnatal age between 8 and 22 weeks AND
• Diagnosed with BPD at 36 weeks postnatal age

Inclusion Criteria Phase 1:

• Birth gestational age of < 29 weeks, AND
• Requiring mechanical ventilation or positive pressure support at 7 days postnatal age, AND
• Postnatal age between 7 and 30 days

Exclusion Criteria:

• Persistent hypoglycemia
• Lactic acidosis
• Feeding intolerance
• Renal or hepatic dysfunction
• Active infection
• Congenital anomalies that preclude feedings
• Infants whose parents have chosen palliative care

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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40 participants in 9 patient groups

Phase 0 - Cohort 1

Experimental group

Description:

5mg/kg/day in two divided doses for three days

Treatment:

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Phase 0 - Cohort 2

Experimental group

Description:

10mg/kg/day in two divided doses for three days

Treatment:

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Phase 0 - Cohort 3

Experimental group

Description:

20mg/kg/day in two divided doses for seven days

Treatment:

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Phase 0 - Cohort 4

Experimental group

Description:

25mg/kg/day in two divided doses for 14 days

Treatment:

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Phase 1 - Cohort 1 Escalation

Experimental group

Description:

15mg/kg/day in a single daily dose for three days

Treatment:

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Phase 1 - Cohort 2 Escalation

Experimental group

Description:

25mg/kg/day in a single daily dose for three days

Treatment:

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Phase 1- Cohort 3 Escalation

Experimental group

Description:

10mg/kg/day in a single daily dose for three days

Treatment:

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Phase 1 - Cohort 4 Expansion

Experimental group

Description:

10-25mg/kg/day (dose selected from either Cohort 2 or 3)

Treatment:

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Phase 1 - Cohort 5 Expansion

Experimental group

Description:

10-25mg/kg/day (dose selected from either Cohort 2 or 3)

Treatment:

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)

Drug: Metformin (open-label)