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

NCT07015450 | Completed Phase 4 DMC

• 1 other identifier: KET-407/UN2.F1/ETIK/PPM.00.02
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 3

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)

Conditions

Neonatal Hypoglycemia

Keywords

asymptomatic transient neonatal hypoglycemia; 40% dextrose gel

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to 30 minutes after intervention

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Intervention group : given self manufactured 40% dextrose gel applied in buccal mucosa region plus standard therapy

Drug: self-manufactured 40% dextrose gel; Drug: Standard therapy

Control Group

PLACEBO COMPARATOR

Control group : given a standard therapy only

Drug: Standard therapy

Interventions

self-manufactured 40% dextrose gel DRUG

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

Intervention Group

Standard therapy DRUG

standard therapy for asymptomatic transient neonatal hypoglycemia

Control Group; Intervention Group

Eligibility Criteria

• Age: 34 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead
• Budi Kemuliaan Hospital: collaborator
• Universitas Indonesia, Cipto Mangunkusumo National General Hospital: collaborator
• RS Prof. Dr. I.G.N.G Ngoerah: collaborator

Study Sites (3)

Prof IG.N.G Ngoerah General Hospital Denpasar

Denpasar, Bali, Indonesia

Location

Budi Kemuliaan Hospital

Jakarta, Jakarta Special Capital Region, Indonesia

Location

Child Health Department, Faculty of Medicine - Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia, Jakarta, Jakarta

Jakarta, Jakarta Special Capital Region, Indonesia

Location

Related Publications (21)

• Neonatal mortality - UNICEF DATA. Accessed October 30, 2023. https://data.unicef.org/topic/child-survival/neonatal-mortality/

  BACKGROUND

• 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.

  PMID: 33489995 BACKGROUND

• Vain NE, Chiarelli F. Neonatal Hypoglycaemia: A Never-Ending Story? Neonatology. 2021;118(5):522-529. doi: 10.1159/000514711. Epub 2021 Mar 22.

  PMID: 33752207 BACKGROUND

• Committee 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.

  PMID: 21357346 BACKGROUND

• Thornton 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.

  PMID: 25957977 BACKGROUND

• Stanley 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.

  PMID: 25819173 BACKGROUND

• Hubbard EM, Hay WW Jr. The Term Newborn: Hypoglycemia. Clin Perinatol. 2021 Aug;48(3):665-679. doi: 10.1016/j.clp.2021.05.013.

  PMID: 34353586 BACKGROUND

• Harris 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.

  PMID: 22727868 BACKGROUND

• Alsaleem 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.

  PMID: 31556318 BACKGROUND

• Thompson-Branch A, Havranek T. Neonatal Hypoglycemia. Pediatr Rev. 2017 Apr;38(4):147-157. doi: 10.1542/pir.2016-0063.

  PMID: 28364046 BACKGROUND

• Adamkin 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.

  PMID: 27605513 BACKGROUND

• Meneghin 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.

  PMID: 34627324 BACKGROUND

• Sharma 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.

  PMID: 27441006 BACKGROUND

• Hu 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.

  PMID: 33107014 BACKGROUND

• Samayam 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.

  PMID: 26500974 BACKGROUND

• Harris DL, Weston PJ, Signal M, Chase JG, Harding JE. Dextrose gel for neonatal hypoglycaemia (the Sugar Babies Study): a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Dec 21;382(9910):2077-83. doi: 10.1016/S0140-6736(13)61645-1. Epub 2013 Sep 25.

  PMID: 24075361 BACKGROUND

• Scheans P, Bennett C, Harris D. Using Dextrose (Glucose) Gel to Reverse Neonatal Hypoglycemia. Neonatal Netw. 2017 Jul 1;36(4):233-238. doi: 10.1891/0730-0832.36.4.233.

  PMID: 28764827 BACKGROUND

• Makker K, Alissa R, Dudek C, Travers L, Smotherman C, Hudak ML. Glucose Gel in Infants at Risk for Transitional Neonatal Hypoglycemia. Am J Perinatol. 2018 Sep;35(11):1050-1056. doi: 10.1055/s-0038-1639338. Epub 2018 Mar 26.

  PMID: 29579758 BACKGROUND

• Arimitsu T, Kasuga Y, Ikenoue S, Saisho Y, Hida M, Yoshino J, Itoh H, Tanaka M, Ochiai D. Risk factors of neonatal hypoglycemia in neonates born to mothers with gestational diabetes. Endocr J. 2023 May 29;70(5):511-517. doi: 10.1507/endocrj.EJ22-0521. Epub 2023 Mar 15.

  PMID: 36792172 BACKGROUND

• Hawdon JM, Weddell A, Aynsley-Green A, Ward Platt MP. Hormonal and metabolic response to hypoglycaemia in small for gestational age infants. Arch Dis Child. 1993 Mar;68(3 Spec No):269-73. doi: 10.1136/adc.68.3_spec_no.269.

  PMID: 8466261 BACKGROUND

• Barber RL, Ekin AE, Sivakumar P, Howard K, O'Sullivan TA. Glucose Gel as a Potential Alternative Treatment to Infant Formula for Neonatal Hypoglycaemia in Australia. Int J Environ Res Public Health. 2018 Apr 27;15(5):876. doi: 10.3390/ijerph15050876.

  PMID: 29702618 BACKGROUND

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Putu Mas Vina Paramitha Cempaka, Dr

  Pediatric Subspecialist Consultant Program, Child Health Department, Faculty of Medicine - Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: May 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (3)