Prevention of Hypoglycaemia by Oral 40% Destrogel

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

Interventions

DIETARY_SUPPLEMENT

Administration of a placebo solution (0.5 ml / kg)

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

DIETARY_SUPPLEMENT

Administration of a placebo solution (1 ml / kg)

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

DIETARY_SUPPLEMENT

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

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

DIETARY_SUPPLEMENT

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

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

Sponsors & Collaborators

• Fondazione Poliambulanza Istituto Ospedaliero

  lead OTHER

Principal Investigators

• Giuseppe De Bernardo, MD · Poliambulanza Foundation Hospital Institute

• Rosario Ippolito, MD · Physician in specialist training of the University of Pavia

• Maurizio Giordano, B.Sc. · Federico II University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

34 Weeks

Max Age

42 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-23

Primary Completion

2019-05-05

Completion

2019-05-05

Countries

• Italy

Study Locations