Oral Glibenclamide for the Treatment of Hyperglycemia in Extremely Preterm Infants – A Retrospective Multicenter Cohort Study

Oral Glibenclamide for the Treatment of Hyperglycemia in Extremely Preterm Infants – A Retrospective Multicenter Cohort Study - Glibenclamide for premmies

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039951

Enrollment

Registered

2026-06-10

Start date

2026-06-02

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia in VLBW Infants

Interventions

Group 1: The study retrospectively evaluates the effectiveness of oral glibenclamide in reducing hyperglycemia in extremely preterm infants, as well as the occurrence of hypoglycemia and the practical

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Included are all preterm infants with a postmenstrual age (gestational age, GA) of <29+0 weeks and with documented hyperglycemia of greater than or equal to 180 mg/dL within a center-specific time period of Osnabrück: 01/01/2007 to 01/01/2026. Hamburg: 01/01/2020 to 01/01/2026 Bielefeld: 01/01/2023 to 01/01/2026 The period refers to the year of first use of glibenclamide in the respective center.

Exclusion criteria

Exclusion criteria: Preterm infants without hyperglycemia are excluded.

Design outcomes

Primary

Measure	Time frame
The primary objective of the study is to evaluate the effectiveness of oral glibenclamide in reducing hyperglycemia in extremely preterm infants. The primary outcome parameter is whether the blood glucose concentration 24 hours after oral administration of glibenclamide (mg/dL) falls within the predefined target range of 80–180 mg/dL.	—

Secondary

Measure	Time frame
Secondary study objectives include evaluating the occurrence of hypoglycemia, as well as the practical feasibility and dose titration of therapy. Accordingly, secondary outcome parameters include the time to onset of euglycemia after administration of glibenclamide (h), glucose concentrations during treatment with glibenclamide (mg/dL), duration of therapy (days), number of individual oral glibenclamide doses (n), and both weight-adjusted and absolute single and cumulative doses of glibenclamide (mg/kg body weight and mg). In addition, the frequency of hypoglycemic events (n) and the glucose concentrations during hypoglycemic episodes (mg/dL) are recorded.	—

Measure

Time frame

Secondary study objectives include evaluating the occurrence of hypoglycemia, as well as the practical feasibility and dose titration of therapy. Accordingly, secondary outcome parameters include the time to onset of euglycemia after administration of glibenclamide (h), glucose concentrations during treatment with glibenclamide (mg/dL), duration of therapy (days), number of individual oral glibenclamide doses (n), and both weight-adjusted and absolute single and cumulative doses of glibenclamide (mg/kg body weight and mg). In addition, the frequency of hypoglycemic events (n) and the glucose concentrations during hypoglycemic episodes (mg/dL) are recorded.

—

Countries

Germany

Contacts

Public ContactLena Wiedenhaus

Universität Bielefeld

lena.wiedenhaus@uni-bielefeld.dekeine Angabe

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026