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NCT Number: NCT07015450

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

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)

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Key information

Conditions

Neonatal Hypoglycemia

Age range

34 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Prof IG.N.G Ngoerah General Hospital Denpasar, Denpasar, Bali, Indonesia

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About this study

Background: Neonatal hypoglycemia (NH) is a metabolic disorder that often occurs in the first few days of life. It is a potential cause of preventable brain injury and neonatal death. Most of hypoglycemia in high risk infants are transient and asymptomatic. One of the additional therapy for asymptomatic transient neonatal hypoglycemia is 40% dextrose gel. The 40% dextrose gel is a promising therapy because it is inexpensive, easy to administer and non-invasive.

Objective: To determine the efficacy of 40% dextrose gel therapy as an additional therapy for the management of asymptomatic transient NH in high risk infants.

Methods: A single-blind, randomized controlled trial was carried out in April-August 2023. The inclusion criteria were infants >34 weeks of gestational age and birth weight >1500 grams with blood sugar levels of 27-<47 mg/dL and without hypoglycemic symptoms. Block randomization was carried out in 60 eligible subjects. Subjects were allocated to 2 groups, the treatment group (40% dextrose gel plus standard therapy) and control group (standard therapy). The self-manufactured 40% dextrose gel was applied in buccal mucosa region. Blood glucose level was measured with glucometer 30 minutes after intervention. Data presented in descriptive and analyzed using chi-square and independent t-test with p<0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants with gestational age >34 weeks and birth weight >1500 grams with one of risk factors for hypoglycemia, such as baby with large for gestational age (LGA), small for gestational age (SGA), intrauterine growth restriction (IUGR), late preterm infants (LPIs), history of antenatal corticosteroid administration for 24 hours to 7 days before delivery; Maternal risk factors: hypertensive mothers, preeclampsia, diabetes type 1 or 2 mothers during or before pregnancy, consumed medication that caused hypoglycemia (terbutaline, b-blockers)
  • Blood sugar levels at 0-4 hours after delivery are 27-<47 mg/dL,
  • The parents agreed to participate in the research

Exclusion criteria

  • birth asphyxia that require active resuscitation and neonatal intensive care unit (NICU) care
  • infants with symptoms of hypoglycemia
  • Infants who have absolute and relative contraindications for enteral and oral feeding.

Treatment and study plan

self-manufactured 40% dextrose gel

Drug

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

Standard therapy

Drug

standard therapy for asymptomatic transient neonatal hypoglycemia

Primary outcomes

  1. Blood Glucose Serum Levels

    Time frame: From enrollment to 30 minutes after intervention

    Blood glucose level was measured from capillary blood with glucometer which validated every two weeks by supervised technician. Blood serum obtained by skilled health workers at 30 minutes after intervention.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Budi Kemuliaan Hospital
  • Dr Cipto Mangunkusumo General Hospital
  • RS Prof. Dr. I.G.N.G Ngoerah

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 11, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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