Research Article: Prophylactic Oral Dextrose Gel for Newborn Babies at Risk of Neonatal Hypoglycaemia: A Randomised Controlled Dose-Finding Trial (the Pre-hPOD Study)

Date Published: October 25, 2016

Publisher: Public Library of Science

Author(s): Joanne Elizabeth Hegarty, Jane Elizabeth Harding, Gregory David Gamble, Caroline Anne Crowther, Richard Edlin, Jane Marie Alsweiler, Jenny E Myers

Abstract: BackgroundNeonatal hypoglycaemia is common, affecting up to 15% of newborns, and can cause brain damage. Currently, there are no strategies, beyond early feeding, to prevent neonatal hypoglycaemia. Our aim was to determine a dose of 40% oral dextrose gel that will prevent neonatal hypoglycaemia in newborn babies at risk.Methods and FindingsWe conducted a randomised, double-blind, placebo-controlled dose-finding trial of buccal dextrose gel to prevent neonatal hypoglycaemia at two hospitals in New Zealand. Babies at risk of hypoglycaemia (infant of a mother with diabetes, late preterm delivery, small or large birthweight, or other risk factors) but without indication for admission to a neonatal intensive care unit (NICU) were randomly allocated either to one of four treatment groups: 40% dextrose at one of two doses (0.5 ml/kg = 200 mg/kg, or 1 ml/kg = 400 mg/kg), either once at 1 h of age or followed by three additional doses of dextrose (0.5 ml/kg before feeds in the first 12 h); or to one of four corresponding placebo groups. Treatments were administered by massaging gel into the buccal mucosa. The primary outcome was hypoglycaemia (<2.6 mM) in the first 48 h. Secondary outcomes included admission to a NICU, admission for hypoglycaemia, and breastfeeding at discharge and at 6 wk. Prespecified potential dose limitations were tolerance of gel, time taken to administer, messiness, and acceptability to parents. From August 2013 to November 2014, 416 babies were randomised. Compared to babies randomised to placebo, the risk of hypoglycaemia was lowest in babies randomised to a single dose of 200 mg/kg dextrose gel (relative risk [RR] 0.68; 95% confidence interval [CI] 0.47–0.99, p = 0.04) but was not significantly different between dose groups (p = 0.21). Compared to multiple doses, single doses of gel were better tolerated, quicker to administer, and less messy, but these limitations were not different between dextrose and placebo gel groups. Babies who received any dose of dextrose gel were less likely to develop hypoglycaemia than those who received placebo (RR 0.79; 95% CI 0.64–0.98, p = 0.03; number needed to treat = 10, 95% CI 5–115). Rates of NICU admission were similar (RR 0.64; 95% CI 0.33–1.25, p = 0.19), but admission for hypoglycaemia was less common in babies randomised to dextrose gel (RR 0.46; 95% CI 0.21–1.01, p = 0.05). Rates of breastfeeding were similar in both groups. Adverse effects were uncommon and not different between groups. A limitation of this study was that most of the babies in the trial were infants of mothers with diabetes (73%), which may reduce the applicability of the results to babies from other risk groups.ConclusionsThe incidence of neonatal hypoglycaemia can be reduced with a single dose of buccal 40% dextrose gel 200 mg/kg. A large randomised trial (Hypoglycaemia Prevention with Oral Dextrose [hPOD]) is under way to determine the effects on NICU admission and later outcomes.Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12613000322730

Partial Text: Approximately 30% of newborn babies require multiple blood tests for screening for neonatal hypoglycaemia under current guidelines. Half of these will develop hypoglycaemia [1], and an unknown proportion will experience brain damage and developmental delay as a result. Despite recommendations in clinical guidelines that prophylactic measures should be taken in babies at risk of neonatal hypoglycaemia [2–4], there currently are no strategies beyond early feeding for prevention [5]. Dextrose gel has been shown to be effective in treating neonatal hypoglycaemia, without detrimental effect on breastfeeding [6]. We therefore considered that it might also be effective as prophylaxis against neonatal hypoglycaemia. However, we first needed to determine an effective dose of dextrose gel to prevent neonatal hypoglycaemia.

The trial was approved by the Northern A Health and Disability Ethics Committee of New Zealand (13/NTA/8).

Our findings show that the most effective and well-tolerated dose of prophylactic oral dextrose gel to reduce the incidence of neonatal hypoglycaemia in babies born at risk but without indication for a NICU admission is 200 mg/kg (0.5 ml/kg of 40% oral dextrose gel). Further, the intervention was easy to administer, well tolerated, acceptable to parents, and not associated with any adverse outcomes. Neonatal hypoglycaemia is a common problem, occurring in up to 15% of newborn babies and in 50% of those born at risk [1]. Management commonly includes supplementary feeds with formula milk and/or separation of mother and baby for admission to a NICU for more invasive management with intravenous dextrose. The use of formula milk is associated with decreased breastfeeding rates [10], and admission to a NICU separates mother and baby, making breastfeeding establishment more difficult as well as increasing health care costs. Other than feeding early [5], there are no effective interventions for prophylaxis of neonatal hypoglycaemia in babies at risk. This trial is the first to demonstrate that oral dextrose gel reduces the incidence of neonatal hypoglycaemia.

Source:

http://doi.org/10.1371/journal.pmed.1002155

 

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