CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 133 enrolled
Drug / intervention
self-manufactured 40% dextrose gel +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07015450
NCT07015450Phase 4Completed

The Efficacy of Self-Manufactured 40% Dextrose Gel as Supplementary to Asymptomatic Transient Neonatal Hypoglycemia Treatment : A Randomized Controlled Trial

Indonesia University·interventional·Posted Jun 11, 2025·Updated Jun 11, 2025

In Brief

A Phase 4 clinical trial evaluating self-manufactured 40% dextrose gel and Standard therapy for Neonatal Hypoglycemia. Completed, enrolled 133 participants across 3 sites.

Detailed Summary

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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndonesia

Timeline

Phase 4CompletedFinished
202420252026
First PostedJun 11, 2025
Enrollment StartMay 1, 2023
Primary CompletionAug 31, 2023
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 1.1 years ago

Interventions

self-manufactured 40% dextrose geldrug

The self-manufactured 40% dextrose gel was applied in buccal mucosa region

Standard therapydrug

standard therapy for asymptomatic transient neonatal hypoglycemia