Prevention of Hypoglycaemia by Oral 40% Destrogel

NCT04185766 | Completed DMC

• 1 other identifier: 3286
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

Neonatal hypoglycemia understood as a reduction in plasma glucose can result in long-term neurological damage. Serious monitoring of neonatal blood glucose is indicated in patients at risk of hypoglycemia. Glycaemic monitoring in the newborn at risk should be started not before of the two hours of life, in fact at birth the neonatal blood glucose values are very low because they are conditioned by the metabolic activity of the foetus in the intrauterine phase, while later these values rise again until arrive at similar values to the adult within 48-72 hours. In recent years, various research groups have been evaluating the possibility of arriving at non-pharmacological prophylaxis of hypoglycemia. In particular, the Hegarty group has set up a protocol that uses dextrose gel at 40% in the risk categories that could reduce the number of hypoglycemia cases and consequently of painful procedures. In 2013 Harris et al. conducted a study to evaluate the failure rate in the treatment of hypoglycaemia in a sample of 242 newborns assigned in the 1:1 ratio to case or control group. The cases were treated with 40% dextrose in gel with a concentration of 200 mg/kg while the controls with a placebo solution. Newborns of both groups were encouraged to feed but if the feeding was insufficient, it was administered breast milk or formula milk through a syringe. Treated group showed a failure rate in reversion of lower hypoglycaemia compared to controls (14% vs 24%, RR = 0.57 (0.33-0.98), p = 0.04). Hegarty et al conducted a clinical trial in which 416 newborns were randomized and assigned to one of 4 types of treatment: dextrose 40% in gel in a single-dose (200 mg/kg) or double-dose (400 mg/kg ) 1 hour after birth or followed by 3 additional doses of dextrose (200 mg/kg) in the first 12 hours. Blood glucose was measured at 2 hours from birth then every 2-4 hours for the first 12 hours of life. The incidence of hypoglycaemia was lower in the treated than in the control group treated with a placebo solution (41% vs 52%, RR = 0.79 (0.64-0.98), p = 0.03). The group of newborns treated with a single administration of gel at a concentration of 200 mg/kg showed a greater reduction in the incidence of hypoglycaemia compared to the other types of treatment (38% vs 56%, RR = 0.66 (0.47-0.99), p=0.04)

Conditions

Hypoglycaemia Neonatal

Keywords

Prevention; newborn; oral destrogel; hypoglycaemia

Outcome Measures

Primary Outcomes (1)

• Change of the incidence of hypoglycaemia in late term newborns and in SGA and LGA term infants

  To assess whether a single administration of Destrogel 40% micronutrient can reduce the incidence of hypoglycaemia in late term newborns and in SGA and LGA term infants (gestational age: 37-42 weeks).

  From birth up to 48 hours of life

Secondary Outcomes (1)

• Change of the incidence of the use of formula milk and the intravenous administration of 10% glucose solution in late term infants and in SGA and LGA term newborns

  From birth up to 48 hours of life

Study Arms (4)

Placebo (0,5 ml/Kg)

PLACEBO COMPARATOR

Dietary Supplement: Administration of a placebo solution (0.5 ml / kg)

Placebo (1 ml/Kg)

PLACEBO COMPARATOR

Dietary Supplement: Administration of a placebo solution (1 ml / kg)

Destrogel (0,5 ml/Kg)

EXPERIMENTAL

Dietary Supplement: Administration of 40% glucose in gel (0.5 ml / Kg)

Destrogel (1 ml/Kg)

EXPERIMENTAL

Dietary Supplement: Administration of 40% glucose in gel 1 ml / Kg)

Interventions

Administration of a placebo solution (0.5 ml / kg) DIETARY_SUPPLEMENT

43 newborns at risk of hypoglycaemia to which a placebo solution will be administered (0.5 ml / kg)

Also known as: Placebo

Placebo (0,5 ml/Kg)

Administration of a placebo solution (1 ml / kg) DIETARY_SUPPLEMENT

43 newborns at risk of hypoglycaemia to which a placebo solution will be administered (1 ml / kg)

Also known as: Placebo

Placebo (1 ml/Kg)

Administration of 40% glucose in gel (0.5 ml / Kg) DIETARY_SUPPLEMENT

43 newborns at risk of hypoglycaemia to which a solution of dextrose 40% in gel will be administered (0.5 ml / Kg)

Destrogel (0,5 ml/Kg)

Administration of 40% glucose in gel 1 ml / Kg) DIETARY_SUPPLEMENT

43 newborns at risk of hypoglycaemia to which a solution of dextrose 40% in gel will be administered (1 ml / Kg).

Destrogel (1 ml/Kg)

Eligibility Criteria

• Age: 34 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Mothers:
• Favourable for breastfeeding
• BMI between 19-24
• Newborns:
• Late preterm (gestational age: 34-36 weeks)
• Term neonates (gestational age: 37-42 weeks), with body weight \<10th centile (SGA) or\> 90 ° centile according to Bertino's neonatal anthropometric evaluation
• Born from eutocic childbirth
• Rooming-in
• Body temperature between 36.5-37.5 ° C 2.

You may not qualify if:

• Mothers:
• Lack of informed consent
• Diabetic mother
• Taking medicines during pregnancy (beta blockers, tolbutamide)
• Newborns:
• Major congenital malformations
• Blood sugar \<47 mg / dl
• Body temperature \<36.5 ° C or\> 37.5 ° C
• NICU admissions
• Milk intake in formula
• Intravenous infusion of 10% glucose solution
• Metabolic and respiratory acidosis (pH: 7.28 - 7.38)

Sponsors & Collaborators

• Fondazione Poliambulanza Istituto Ospedaliero: lead

Study Sites (1)

Poliambulanza Foundation Hospital Institute

Brescia, 25124, Italy

Location

Related Publications (16)

• Raylene P. The sacred hour: uninterrupted skin-to-skin contact immediately after birth. Newborn & Infant Nursing Reviews 2013; 13:67-72

  BACKGROUND

• Rana A, Amr M, Patty W, Sandy I, Mandy. Validation Study of: The Effect of Delayed Newborn Bath and Oral Dextrose Gel for Neonatal Hypoglycemia on Improving In-Hospital Exclusive Breastfeeding Rates. Biomed J Sci &Tech Res 4(4) 2018.BJSTR.MS.ID.0001090

  BACKGROUND

• Oral Dextrose Gel to Treat Neonatal Hypoglycaemia: New Zealand Clinical Practice Guidelines 2015. Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand

  BACKGROUND

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

  PMID: 28364046 RESULT

• McKinlay CJ, Alsweiler JM, Ansell JM, Anstice NS, Chase JG, Gamble GD, Harris DL, Jacobs RJ, Jiang Y, Paudel N, Signal M, Thompson B, Wouldes TA, Yu TY, Harding JE; CHYLD Study Group. Neonatal Glycemia and Neurodevelopmental Outcomes at 2 Years. N Engl J Med. 2015 Oct 15;373(16):1507-18. doi: 10.1056/NEJMoa1504909.

  PMID: 26465984 RESULT

• Engle WA, Kominiarek MA. Late preterm infants, early term infants, and timing of elective deliveries. Clin Perinatol. 2008 Jun;35(2):325-41, vi. doi: 10.1016/j.clp.2008.03.003.

  PMID: 18456072 RESULT

• 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 RESULT

• McKinlay CJD, Alsweiler JM, Anstice NS, Burakevych N, Chakraborty A, Chase JG, Gamble GD, Harris DL, Jacobs RJ, Jiang Y, Paudel N, San Diego RJ, Thompson B, Wouldes TA, Harding JE; Children With Hypoglycemia and Their Later Development (CHYLD) Study Team. Association of Neonatal Glycemia With Neurodevelopmental Outcomes at 4.5 Years. JAMA Pediatr. 2017 Oct 1;171(10):972-983. doi: 10.1001/jamapediatrics.2017.1579.

  PMID: 28783802 RESULT

• Lago P, Frigo AC, Baraldi E, Pozzato R, Courtois E, Rambaud J, Anand KJ, Carbajal R. Sedation and analgesia practices at Italian neonatal intensive care units: results from the EUROPAIN study. Ital J Pediatr. 2017 Mar 7;43(1):26. doi: 10.1186/s13052-017-0343-2.

  PMID: 28270167 RESULT

• Hegarty JE, Harding JE, Gamble GD, Crowther CA, Edlin R, Alsweiler JM. Prophylactic Oral Dextrose Gel for Newborn Babies at Risk of Neonatal Hypoglycaemia: A Randomised Controlled Dose-Finding Trial (the Pre-hPOD Study). PLoS Med. 2016 Oct 25;13(10):e1002155. doi: 10.1371/journal.pmed.1002155. eCollection 2016 Oct.

  PMID: 27780197 RESULT

• Futatani T, Shimao A, Ina S, Higashiyama H, Fujita S, Ueno K, Igarashi N, Hatasaki K. Capillary Blood Ketone Levels as an Indicator of Inadequate Breast Milk Intake in the Early Neonatal Period. J Pediatr. 2017 Dec;191:76-81. doi: 10.1016/j.jpeds.2017.08.080.

  PMID: 29173326 RESULT

• Spatz DL. Helping Mothers Reach Personal Breastfeeding Goals. Nurs Clin North Am. 2018 Jun;53(2):253-261. doi: 10.1016/j.cnur.2018.01.011.

  PMID: 29779517 RESULT

• Chertok IR, Raz I, Shoham I, Haddad H, Wiznitzer A. Effects of early breastfeeding on neonatal glucose levels of term infants born to women with gestational diabetes. J Hum Nutr Diet. 2009 Apr;22(2):166-9. doi: 10.1111/j.1365-277X.2008.00921.x. Epub 2009 Feb 13.

  PMID: 19226355 RESULT

• 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 RESULT

• Weston PJ, Harris DL, Battin M, Brown J, Hegarty JE, Harding JE. Oral dextrose gel for the treatment of hypoglycaemia in newborn infants. Cochrane Database Syst Rev. 2016 May 4;(5):CD011027. doi: 10.1002/14651858.CD011027.pub2.

  PMID: 27142842 RESULT

• 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 RESULT

MeSH Terms

Conditions

Hypoglycemia

Interventions

Glucose; Gels

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Giuseppe De Bernardo, MD

  Poliambulanza Foundation Hospital Institute

  PRINCIPAL INVESTIGATOR

• Rosario Ippolito, MD

  Physician in specialist training of the University of Pavia

  STUDY CHAIR

• Maurizio Giordano, B.Sc.

  Federico II University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2019
• First Posted: December 4, 2019
• Study Start: November 23, 2018
• Primary Completion: May 5, 2019
• Study Completion: May 5, 2019
• Last Updated: December 4, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)