Clinical trial NCT07015450: The Efficacy of Self-Manufactured 40% Dextrose Gel in Asymptomatic Transient Neonatal Hypoglycemia Treatment
Official title: The Efficacy of Self-Manufactured 40% Dextrose Gel as Supplementary to Asymptomatic Transient Neonatal Hypoglycemia Treatment : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neonatal Hypoglycemia
Keywords: asymptomatic transient neonatal hypoglycemia
40% dextrose gel
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Budi Kemuliaan Hospital
name: Universitas Indonesia, Cipto Mangunkusumo National General Hospital
name: RS Prof. Dr. I.G.N.G Ngoerah
First posted: 2025-06-11
Enrollment: 133
Sex: ALL
Minimum age (years): 34
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood Glucose Serum Levels
timeFrame: From enrollment to 30 minutes after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Prof IG.N.G Ngoerah General Hospital Denpasar
state: Bali
city: Jakarta
country: Indonesia
facility: Budi Kemuliaan Hospital
city: Jakarta
country: Indonesia
facility: Child Health Department, Faculty of Medicine - Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia, Jakarta, Jakarta
Study officials:
affiliation: Pediatric Subspecialist Consultant Program, Child Health Department, Faculty of Medicine - Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia
name: Putu Mas Vina Paramitha Cempaka, Dr
role: PRINCIPAL_INVESTIGATOR
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