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

NCT07015450 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2025-06-11

No results posted yet for this study

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)

Conditions

  • Neonatal Hypoglycemia

Interventions

DRUG

self-manufactured 40% dextrose gel

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

DRUG

Standard therapy

standard therapy for asymptomatic transient neonatal hypoglycemia

Sponsors & Collaborators

  • Budi Kemuliaan Hospital

    collaborator UNKNOWN

  • Universitas Indonesia, Cipto Mangunkusumo National General Hospital

    collaborator UNKNOWN

  • RS Prof. Dr. I.G.N.G Ngoerah

    collaborator UNKNOWN

  • Indonesia University

    lead OTHER

Principal Investigators

  • Putu Mas Vina Paramitha Cempaka, Dr · Pediatric Subspecialist Consultant Program, Child Health Department, Faculty of Medicine - Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
34 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2023-08-31
Completion
2023-08-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07015450 on ClinicalTrials.gov