Neonatal HypoglycemiaPhase 4NCT07015450
The Efficacy of Self-Manufactured 40% Dextrose Gel in Asymptomatic Transient Neonatal Hypoglycemia Treatment
A Phase 4 study testing self-manufactured 40% dextrose gel and Standard therapy in people with Neonatal Hypoglycemia, run by Universitas Indonesia at 3 sites in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 34 weeks and older
- Conditions the study is for
- Neonatal Hypoglycemia
- What is being tested?
- self-manufactured 40% dextrose gel and Standard therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 3 sitesIndonesia
- Study dates
- 1 May 2023to 31 Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
Prof IG.N.G Ngoerah General Hospital Denpasar
Denpasar, Bali
Budi Kemuliaan Hospital
Jakarta, Jakarta Special Capital Region
Child Health Department, Faculty of Medicine - Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia, Jakarta, Jakarta
Jakarta, Jakarta Special Capital Region
About this study
Official title: The Efficacy of Self-Manufactured 40% Dextrose Gel as Supplementary to Asymptomatic Transient Neonatal Hypoglycemia Treatment : A Randomized Controlled Trial
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:
Read more
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)
Read the 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.
- Conditions
- Neonatal Hypoglycemia
- Being tested
- self-manufactured 40% dextrose gel, Standard therapy
- Keywords
- asymptomatic transient neonatal hypoglycemia, 40% dextrose gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Intervention group : given self manufactured 40% dextrose gel applied in buccal mucosa region plus standard therapy Receives: Drug: self-manufactured 40% dextrose gel; Drug: Standard therapy |
| Control Group | Placebo comparator | Control group : given a standard therapy only Receives: Drug: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose Serum Levels
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.
Measured: From enrollment to 30 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 May 2023
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Neonatal HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Budi Kemuliaan Hospital, Dr Cipto Mangunkusumo General Hospital, RSUP Prof. Dr. I.G.N.G. Ngoerahal
- Responsible party
- Principal investigator, Rosalina Dewi Roeslani, Universitas Indonesia
- Investigators
- Putu Mas Vina Paramitha Cempaka, Dr, Principal investigator, Pediatric Subspecialist Consultant Program, Child Health Department, Faculty of Medicine - Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015450
- Sponsor's protocol ID
- KET-407/UN2.F1/ETIK/PPM.00.02
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Neonatal mortality - UNICEF DATA. Accessed October 30, 2023. https://data.unicef.org/topic/child-survival/neonatal-mortality/
Edwards T, Harding JE. Clinical Aspects of Neonatal Hypoglycemia: A Mini Review. Front Pediatr. 2021 Jan 8;8:562251. doi: 10.3389/fped.2020.562251. eCollection 2020.
PubMed 33489995Vain NE, Chiarelli F. Neonatal Hypoglycaemia: A Never-Ending Story? Neonatology. 2021;118(5):522-529. doi: 10.1159/000514711. Epub 2021 Mar 22.
PubMed 33752207Committee on Fetus and Newborn; Adamkin DH. Postnatal glucose homeostasis in late-preterm and term infants. Pediatrics. 2011 Mar;127(3):575-9. doi: 10.1542/peds.2010-3851. Epub 2011 Feb 28.
PubMed 21357346Thornton PS, Stanley CA, De Leon DD, Harris D, Haymond MW, Hussain K, Levitsky LL, Murad MH, Rozance PJ, Simmons RA, Sperling MA, Weinstein DA, White NH, Wolfsdorf JI; Pediatric Endocrine Society. Recommendations from the Pediatric Endocrine Society for Evaluation and Management of Persistent Hypoglycemia in Neonates, Infants, and Children. J Pediatr. 2015 Aug;167(2):238-45. doi: 10.1016/j.jpeds.2015.03.057. Epub 2015 May 6. No abstract available.
PubMed 25957977Stanley CA, Rozance PJ, Thornton PS, De Leon DD, Harris D, Haymond MW, Hussain K, Levitsky LL, Murad MH, Simmons RA, Sperling MA, Weinstein DA, White NH, Wolfsdorf JI. Re-evaluating "transitional neonatal hypoglycemia": mechanism and implications for management. J Pediatr. 2015 Jun;166(6):1520-5.e1. doi: 10.1016/j.jpeds.2015.02.045. Epub 2015 Mar 25. No abstract available.
PubMed 25819173Hubbard EM, Hay WW Jr. The Term Newborn: Hypoglycemia. Clin Perinatol. 2021 Aug;48(3):665-679. doi: 10.1016/j.clp.2021.05.013.
PubMed 34353586Harris DL, Weston PJ, Harding JE. Incidence of neonatal hypoglycemia in babies identified as at risk. J Pediatr. 2012 Nov;161(5):787-91. doi: 10.1016/j.jpeds.2012.05.022. Epub 2012 Jun 23.
PubMed 22727868Alsaleem M, Saadeh L, Kamat D. Neonatal Hypoglycemia: A Review. Clin Pediatr (Phila). 2019 Nov;58(13):1381-1386. doi: 10.1177/0009922819875540. Epub 2019 Sep 26. No abstract available.
PubMed 31556318Thompson-Branch A, Havranek T. Neonatal Hypoglycemia. Pediatr Rev. 2017 Apr;38(4):147-157. doi: 10.1542/pir.2016-0063.
PubMed 28364046Adamkin DH. Neonatal hypoglycemia. Semin Fetal Neonatal Med. 2017 Feb;22(1):36-41. doi: 10.1016/j.siny.2016.08.007. Epub 2016 Sep 4.
PubMed 27605513Meneghin F, Manzalini M, Acunzo M, Daniele I, Bastrenta P, Castoldi F, Cavigioli F, Zuccotti GV, Lista G. Management of asymptomatic hypoglycemia with 40% oral dextrose gel in near term at-risk infants to reduce intensive care need and promote breastfeeding. Ital J Pediatr. 2021 Oct 9;47(1):201. doi: 10.1186/s13052-021-01149-7.
PubMed 34627324Sharma D, Shastri S, Sharma P. Intrauterine Growth Restriction: Antenatal and Postnatal Aspects. Clin Med Insights Pediatr. 2016 Jul 14;10:67-83. doi: 10.4137/CMPed.S40070. eCollection 2016.
PubMed 27441006Hu J, Benny P, Wang M, Ma Y, Lambertini L, Peter I, Xu Y, Lee MJ. Intrauterine Growth Restriction Is Associated with Unique Features of the Reproductive Microbiome. Reprod Sci. 2021 Mar;28(3):828-837. doi: 10.1007/s43032-020-00374-5. Epub 2020 Oct 26.
PubMed 33107014Samayam P, Ranganathan PK, Kotari UD, Balasundaram R. Study of Asymptomatic Hypoglycemia in Full Term Exclusively Breastfed Neonates in First 48 Hours of Life. J Clin Diagn Res. 2015 Sep;9(9):SC07-10. doi: 10.7860/JCDR/2015/14971.6610. Epub 2015 Sep 1.
PubMed 26500974
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Self-Manufactured 40% Dextrose Gel as Supplementary to Asymptomatic Transient Neonatal Hypoglycemia Treatment : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07015450
- Acronym / sponsor ID
- KET-407/UN2.F1/ETIK/PPM.00.02
- Conditions
- Neonatal Hypoglycemia
- Keywords
- asymptomatic transient neonatal hypoglycemia, 40% dextrose gel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Budi Kemuliaan Hospital, Dr Cipto Mangunkusumo General Hospital, RSUP Prof. Dr. I.G.N.G. Ngoerahal
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Drug: self-manufactured 40% dextrose gel, Drug: Standard therapyIntervention group : given self manufactured 40% dextrose gel applied in buccal mucosa region plus standard therapy |
| Control Group | Placebo comparator | Drug: Standard therapyControl group : given a standard therapy only |
Who may qualify
- Ages
- 34 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-manufactured 40% dextrose gelThe self-manufactured 40% dextrose gel was applied in buccal mucosa region | Drug | Intervention Group |
| Standard therapystandard therapy for asymptomatic transient neonatal hypoglycemia | Drug | Control Group, Intervention Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Results publicationNeonatal mortality - UNICEF DATA. Accessed October 30, 2023. https://data.unicef.org/topic/child-survival/neonatal-mortality/
- Results publication: PubMed 33489995Edwards T, Harding JE. Clinical Aspects of Neonatal Hypoglycemia: A Mini Review. Front Pediatr. 2021 Jan 8;8:562251. doi: 10.3389/fped.2020.562251. eCollection 2020.
- Results publication: PubMed 33752207Vain NE, Chiarelli F. Neonatal Hypoglycaemia: A Never-Ending Story? Neonatology. 2021;118(5):522-529. doi: 10.1159/000514711. Epub 2021 Mar 22.
- Results publication: PubMed 21357346Committee on Fetus and Newborn; Adamkin DH. Postnatal glucose homeostasis in late-preterm and term infants. Pediatrics. 2011 Mar;127(3):575-9. doi: 10.1542/peds.2010-3851. Epub 2011 Feb 28.
- Results publication: PubMed 25957977Thornton PS, Stanley CA, De Leon DD, Harris D, Haymond MW, Hussain K, Levitsky LL, Murad MH, Rozance PJ, Simmons RA, Sperling MA, Weinstein DA, White NH, Wolfsdorf JI; Pediatric Endocrine Society. Recommendations from the Pediatric Endocrine Society for Evaluation and Management of Persistent Hypoglycemia in Neonates, Infants, and Children. J Pediatr. 2015 Aug;167(2):238-45. doi: 10.1016/j.jpeds.2015.03.057. Epub 2015 May 6. No abstract available.
- Results publication: PubMed 25819173Stanley CA, Rozance PJ, Thornton PS, De Leon DD, Harris D, Haymond MW, Hussain K, Levitsky LL, Murad MH, Simmons RA, Sperling MA, Weinstein DA, White NH, Wolfsdorf JI. Re-evaluating "transitional neonatal hypoglycemia": mechanism and implications for management. J Pediatr. 2015 Jun;166(6):1520-5.e1. doi: 10.1016/j.jpeds.2015.02.045. Epub 2015 Mar 25. No abstract available.
- Results publication: PubMed 34353586Hubbard EM, Hay WW Jr. The Term Newborn: Hypoglycemia. Clin Perinatol. 2021 Aug;48(3):665-679. doi: 10.1016/j.clp.2021.05.013.
- Results publication: PubMed 22727868Harris DL, Weston PJ, Harding JE. Incidence of neonatal hypoglycemia in babies identified as at risk. J Pediatr. 2012 Nov;161(5):787-91. doi: 10.1016/j.jpeds.2012.05.022. Epub 2012 Jun 23.
- Results publication: PubMed 31556318Alsaleem M, Saadeh L, Kamat D. Neonatal Hypoglycemia: A Review. Clin Pediatr (Phila). 2019 Nov;58(13):1381-1386. doi: 10.1177/0009922819875540. Epub 2019 Sep 26. No abstract available.
- Results publication: PubMed 28364046Thompson-Branch A, Havranek T. Neonatal Hypoglycemia. Pediatr Rev. 2017 Apr;38(4):147-157. doi: 10.1542/pir.2016-0063.
- Results publication: PubMed 27605513Adamkin DH. Neonatal hypoglycemia. Semin Fetal Neonatal Med. 2017 Feb;22(1):36-41. doi: 10.1016/j.siny.2016.08.007. Epub 2016 Sep 4.
- Results publication: PubMed 34627324Meneghin F, Manzalini M, Acunzo M, Daniele I, Bastrenta P, Castoldi F, Cavigioli F, Zuccotti GV, Lista G. Management of asymptomatic hypoglycemia with 40% oral dextrose gel in near term at-risk infants to reduce intensive care need and promote breastfeeding. Ital J Pediatr. 2021 Oct 9;47(1):201. doi: 10.1186/s13052-021-01149-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Putu Mas Vina Paramitha Cempaka, Dr principal investigator
Pediatric Subspecialist Consultant Program, Child Health Department, Faculty of Medicine - Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing self-manufactured 40% dextrose gel and Standard therapy in people with Neonatal Hypoglycemia, run by Universitas Indonesia at 3 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose Serum Levels (time frame: From enrollment to 30 minutes after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07015450, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.