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NCT07015450

The Efficacy of Self-Manufactured 40% Dextrose Gel in Asymptomatic Transient Neonatal Hypoglycemia Treatment

Completed Phase 4 Last updated 11 June 2025
What this trial tests

Phase 4 trial testing self-manufactured 40% dextrose gel in Neonatal Hypoglycemia in 133 participants. Completed in 31 August 2023.

Timeline
1 May 2023
Primary endpoint
31 August 2023
31 August 2023

Quick facts

Lead sponsorIndonesia University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment133
Start date1 May 2023
Primary completion31 August 2023
Estimated completion31 August 2023
Sites3 locations across Indonesia

Drugs / interventions tested

Conditions studied

Sponsor

Indonesia University

Who can join

34 Weeks and older, any sex, with Neonatal Hypoglycemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to determine the efficacy of 40% dextrose gel therapy as an additional therapy for the management of asymptomatic transient neonatal hypoglycemia in high risk infants The main question it aims to answer is: Is 40% dextrose gel effective for the management of asymptomatic transient NH in high risk infants? Researchers will compare the use of 40% dextrose gel as an additional therapy to the standard treatment and the use of breastmilk or formula milk according standard hypoglycemia treatment only to see if 40% dextrose gel is superior than standard therapy for management as asymptomatic transient NH in high risk infants. Participants will : * Receive 40% dextrose gel plus standard therapy or standard therapy only * Blood glucose level measurement (30 minutes after intervention)

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Neonatal Hypoglycemia

Currently open trials in the same condition.

Other Indonesia University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07015450.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing