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

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)

Timeline

Start

2023-05-01

Primary completion

2023-08-31

Completion

2023-08-31

Publications

• Results Neonatal mortality - UNICEF DATA. Accessed October 30, 2023. https://data.unicef.org/topic/child-survival/neonatal-mortality/
• Results 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.
• Results Vain NE, Chiarelli F. Neonatal Hypoglycaemia: A Never-Ending Story? Neonatology. 2021;118(5):522-529. doi: 10.1159/000514711. Epub 2021 Mar 22.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results Thompson-Branch A, Havranek T. Neonatal Hypoglycemia. Pediatr Rev. 2017 Apr;38(4):147-157. doi: 10.1542/pir.2016-0063.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.

Drugs

Indications

No indication recorded.