Metformin for Premature Infants With Bronchopulmonary Dysplasia
- Conditions
- Bronchopulmonary Dysplasia (BPD)
- Interventions
- Registration Number
- NCT07120971
- Lead Sponsor
- Medical College of Wisconsin
- Brief Summary
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?
- Detailed 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
- Persistent hypoglycemia
- Lactic acidosis
- Feeding intolerance
- Renal or hepatic dysfunction
- Active infection
- Congenital anomalies that preclude feedings
- Infants whose parents have chosen palliative care
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 0 - Cohort 1 Metformin (open-label) 5mg/kg/day in two divided doses for three days Phase 0 - Cohort 2 Metformin (open-label) 10mg/kg/day in two divided doses for three days Phase 0 - Cohort 3 Metformin (open-label) 20mg/kg/day in two divided doses for seven days Phase 0 - Cohort 4 Metformin (open-label) 25mg/kg/day in two divided doses for 14 days Phase 1 - Cohort 1 Escalation Metformin (open-label) 15mg/kg/day in a single daily dose for three days Phase 1 - Cohort 2 Escalation Metformin (open-label) 25mg/kg/day in a single daily dose for three days Phase 1- Cohort 3 Escalation Metformin (open-label) 10mg/kg/day in a single daily dose for three days Phase 1 - Cohort 4 Expansion Metformin (open-label) 10-25mg/kg/day (dose selected from either Cohort 2 or 3) Phase 1 - Cohort 5 Expansion Metformin (open-label) 10-25mg/kg/day (dose selected from either Cohort 2 or 3)
- Primary Outcome Measures
Name Time Method Number of participants who tolerate metformin 14 days after administration of the first dose of metformin Number of subjects who receive enteral doses of metformin and complete the study days without an adverse event while continuing enteral feedings
Number of participants with treatment-related adverse events 14 days after administration of the first dose of metformin Number of participants who develop hypoglycemia defined as blood glucose value \<50
Number of participants with treatment-related metabolic acidosis 14 days after administration of the first dose of metformin Number of subjects who develop lactic acid levels \> 5mmol/L
Number of subjects with treatment-related feeding problems 14 days after administration of the first dose of metformin Number of subjects who require a decrease in enteral feeding volume by \>50% from baseline
Number of subjects who require dose adjustments of metformin 14 days after administration of the first dose of metformin Number of subjects who need decreases in dose or discontinuation of metformin due to hepatic or renal dysfunction
Number of subjects with respiratory deterioration 14 days after administration of the first dose of metformin Number of subjects who develop pneumonia and increases in oxygen concentration and ventilator support during the study
Number of subjects who complete pharmacokinetic evaluation of metformin 14 days after administration of the first dose of metformin Number of subjects who have at least one metformin concentration in blood measured at 1, 4 and 12 hours after an enteric dose
Pharmacokinetic analysis of metformin 14 days after administration of the first dose of metformin Area under the curve of Plasma Concentration Versus Time (AUC) of metformin over a time frame of 1, 4 and 12 hours after an enteric dose of metformin.
Number of subjects who complete the treatment protocol 14 days after administration of the first dose of metformin Number of subjects who complete the study doses of enteric metformin
- Secondary Outcome Measures
Name Time Method Incidence of bronchopulmonary dysplasia 14 days after administration of the first dose of metformin Number of subjects who are diagnosed with bronchopulmonary dysplasia
Incidence of necrotizing enterocolitis 14 days after administration of the first dose of metformin Number of subjects who are diagnosed with necrotizing enterocolitis
Incidence of retinopathy of prematurity 14 days after administration of the first dose of metformin Number of subjects who are diagnosed with retinopathy of prematurity
Incidence of intraventricular hemorrhage 14 days after administration of the first dose of metformin Number of subjects who are diagnosed with intraventricular hemorrhage
Incidence of patent ductus arteriosus 14 days after administration of the first dose of metformin Number of subjects who are diagnosed with patent ductus arteriosus
Trial Locations
- Locations (1)
Children's Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Children's Wisconsin🇺🇸Milwaukee, Wisconsin, United StatesKathleen Meskin, BSN, RN, CCRPContact414-337-7171kmeskin@mcw.eduG. Ganesh Konduri, MD, MSPrincipal InvestigatorRu-Jeng Teng, MDSub Investigator