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NCT07015450
The Efficacy of Self-Manufactured 40% Dextrose Gel in Asymptomatic Transient Neonatal Hypoglycemia Treatment
Phase 4 trial testing self-manufactured 40% dextrose gel in Neonatal Hypoglycemia in 133 participants. Completed in 31 August 2023.
31 August 2023
Quick facts
| Lead sponsor | Indonesia University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 133 |
| Start date | 1 May 2023 |
| Primary completion | 31 August 2023 |
| Estimated completion | 31 August 2023 |
| Sites | 3 locations across Indonesia |
Drugs / interventions tested
- self-manufactured 40% dextrose gel — full drug profile →
- Standard therapy — full drug profile →
Conditions studied
- Neonatal Hypoglycemia — all drugs for Neonatal Hypoglycemia →
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:
- PubMed search for NCT07015450
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07015450 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Indonesia University
- Last refreshed: 11 June 2025
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