drugset / Trial / NCT01688674

Dextrose Infusion by Burettes Versus Dextrose Boluses in Prevention of Neonatal Hypoglycemia

NCT01688674 ↗

Terminated 140 enrolled Makerere University
RandomizedSingle-groupOpen-labelPrevention

Summary

NULL HYPOTHESIS • There is no difference in the incidence of hypoglycemia among preterms receiving either two hourly 10% dextrose boluses or 10% dextrose infusion by burettes during the 72 hours of admission in Special Care Unit- Mulago Hospital. ALTERNATE HYPOTHESIS • Use of two hourly 10% dextrose boluses increases the incidence of hypoglycemia by 30% compared to 10% dextrose infusion by burettes among preterms admitted to Special Care Unit in the first 72 hours of admission.

Timeline

Start
2012-02
Primary completion
2012-04
Completion
2012-04

Outcome

Met primary endpoint

Stopped: “There was more benefit from the infusion arm compared to the bolus arm.”

paper The incidence of hypoglycemia in the bolus arm was 59% (40/68) compared to 11% (8/72) in the infusion arm (RR; 0.19, 95% CI; 0.09-0.37). PMID 25352865 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dextrose Unknown 10 % Intravenous

Indications

No indication recorded.