Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Metformin (open-label)

    Drug

    Enteric metformin 5mg/kg/day in two divided doses will be given for three days to two subjects

  • Metformin (open-label)

    Drug

    Enteric metformin 10mg/kg/day in two divided doses will be given for three days to two subjects.

  • Metformin (open-label)

    Drug

    Enteric metformin 20mg/kg/day in two divided doses will be given for seven days to three subjects.

  • Metformin (open-label)

    Drug

    Enteric metformin 25mg/kg/day in two divided doses will be given for 14 days to three subjects.

  • Metformin (open-label)

    Drug

    Enteric metformin 15mg/kg/day in a single daily dose will be given for three days to 3-6 subjects. Depending on tolerance, the next Cohort will increase to 25mg/kg/day (Cohort 2) or decrease to 10mg/kg/day (Cohort 3)

  • Metformin (open-label)

    Drug

    Enteric metformin 25mg/kg/day in a single daily dose will be given for three days to 3-6 subjects. Depending on tolerance, either 25mg/kg/day or 15mg/kg/day will be dose selected for the next Cohort (Cohort 4)

  • Metformin (open-label)

    Drug

    Enteric metformin 10mg/kg/day in a single daily dose will be given for three days to 3-6 subjects. Depending on tolerance, either 10mg/kg/day dose selected for the next Cohort (Cohort 4) or the study will be stopped due to excessive toxicity.

  • Metformin (open-label)

    Drug

    The dose for this cohort will be selected from either Cohort 2 or 3 based on tolerance. Enteric metformin 10-25mg/kg/day in a single daily dose will be given for seven days to 6 subjects.

  • Metformin (open-label)

    Drug

    The dose for this cohort will be the same as Cohort 4. Enteric metformin 10-25mg/kg/day in a single daily dose will be given for 14 days to 6 subjects.

Treatment groups

40 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Phase 0 - Cohort 1Experimental treatment 1 intervention
Group B: Phase 0 - Cohort 2Experimental treatment 1 intervention
Group C: Phase 0 - Cohort 3Experimental treatment 1 intervention
Group D: Phase 0 - Cohort 4Experimental treatment 1 intervention
Group E: Phase 1 - Cohort 1 EscalationExperimental treatment 1 intervention
Group F: Phase 1 - Cohort 2 EscalationExperimental treatment 1 intervention
Group G: Phase 1- Cohort 3 EscalationExperimental treatment 1 intervention
Group H: Phase 1 - Cohort 4 ExpansionExperimental treatment 1 intervention
Group I: Phase 1 - Cohort 5 ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants who tolerate metformin

Number of subjects who receive enteral doses of metformin and complete the study days without an adverse event while continuing enteral feedings

Time frame
14 days after administration of the first dose of metformin
2

Number of participants with treatment-related adverse events

Number of participants who develop hypoglycemia defined as blood glucose value \<50

Time frame
14 days after administration of the first dose of metformin
3

Number of participants with treatment-related metabolic acidosis

Number of subjects who develop lactic acid levels \> 5mmol/L

Time frame
14 days after administration of the first dose of metformin
4

Number of subjects with treatment-related feeding problems

Number of subjects who require a decrease in enteral feeding volume by \>50% from baseline

Time frame
14 days after administration of the first dose of metformin

Secondary outcomes

1

Incidence of bronchopulmonary dysplasia

Number of subjects who are diagnosed with bronchopulmonary dysplasia

Time frame
14 days after administration of the first dose of metformin
2

Incidence of necrotizing enterocolitis

Number of subjects who are diagnosed with necrotizing enterocolitis

Time frame
14 days after administration of the first dose of metformin
3

Incidence of retinopathy of prematurity

Number of subjects who are diagnosed with retinopathy of prematurity

Time frame
14 days after administration of the first dose of metformin
4

Incidence of intraventricular hemorrhage

Number of subjects who are diagnosed with intraventricular hemorrhage

Time frame
14 days after administration of the first dose of metformin

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical College of Wisconsin

Lead sponsor

Source ClinicalTrials.gov
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