NCT04185766

Prevention of Hypoglycaemia by Oral 40% Destrogel

Completed NA Last updated 4 December 2019

What this trial tests

NA trial testing Administration of a placebo solution (0.5 ml / kg) in Hypoglycaemia Neonatal in 172 participants. Completed in 5 May 2019.

Timeline

23 November 2018

Primary endpoint
5 May 2019

5 May 2019

Quick facts

Lead sponsor	Fondazione Poliambulanza Istituto Ospedaliero
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	172
Start date	23 November 2018
Primary completion	5 May 2019
Estimated completion	5 May 2019
Sites	1 location across Italy

Drugs / interventions tested

• Administration of a placebo solution (0.5 ml / kg)
• Administration of a placebo solution (1 ml / kg)
• Administration of 40% glucose in gel (0.5 ml / Kg)
• Administration of 40% glucose in gel 1 ml / Kg)

Conditions studied

• Hypoglycaemia Neonatal — all drugs for Hypoglycaemia Neonatal →

Sponsor

Fondazione Poliambulanza Istituto Ospedaliero — full company profile →

Who can join

Adults 34 Weeks to 42 Weeks, any sex, with Hypoglycaemia Neonatal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Strategies to improve neurodevelopmental outcomes in babies at risk of neonatal hypoglycaemia.
   Alsweiler JM, Harris DL, Harding JE, McKinlay CJD. · · 2021 · cited 23× · PMID 33836151 · DOI 10.1016/s2352-4642(20)30387-4
2. Oral dextrose gel to prevent hypoglycaemia in at-risk neonates.
   Edwards T, Liu G, Hegarty JE, Crowther CA, et al · · 2021 · cited 21× · PMID 33998668 · DOI 10.1002/14651858.cd012152.pub3
3. Oral dextrose gel to prevent hypoglycaemia in at-risk neonates.
   Roberts L, Lin L, Alsweiler J, Edwards T, et al · · 2023 · cited 12× · PMID 38014716 · DOI 10.1002/14651858.cd012152.pub4