For a study, researchers sought to investigate the effects of preventive dextrose gel on subsequent development in infants born at risk of neonatal hypoglycemia. From January 2015 to May 2019, a multicenter randomized clinical study was undertaken in 18 institutions. Participants were at-risk late preterm or term children who were randomized in 9 sites (n=1359) and followed up between January 2017 and July 2021. Prophylactic 40%% dextrose (n=681) or placebo (n=678) gel, 0.5 mL/kg, was rubbed into the buccal mucosa 1 hour after delivery. The follow-up study’s primary endpoint was neurosensory impairment at 2 years corrected age. There were 44 secondary outcomes, including Bayley-III composite cognition, linguistic, and motor scores (mean [SD], 100 [15]; higher scores indicate better performance).
About 1,197 (91%) of all eligible newborns were evaluated (581 females [49%]). Neurosensory impairment did not differ substantially between the dextrose gel and placebo gel groups (20.8% vs 18.7%; unadjusted risk difference [RD], 2.09% [95% CI, -2.43% to 6.60%]; adjusted risk ratio [aRR], 1.13 [95% CI, 0.90 to 1.41]). The risk of cognitive and language delay did not differ significantly between the dextrose and placebo groups (cognitive: 7.6% vs 5.3%; RD, 2.32% [95% CI, -0.46% to 5.11%]; aRR, 1.40 [95% CI, 0.91 to 2.17]; language: 17.0% vs 14.7%; RD, 2.35% [95% CI, -1.80% to 6.50%]; aRR, 1.19 [95% CI, 0.92 to 1.54]). The dextrose gel group, on the other hand, had a significantly higher risk of motor delay (2.5% vs 0.7% ; RD, 1.81% [95% CI, 0.40% to 3.23%]; aRR, 3.79 [95% CI, 1.27 to 11.32]) and significantly lower composite scores for cognitive (adjusted mean difference [aMD], -1.30 [95% CI, 2.55 to 0.05]), language (aMD, −2.16 [95% CI, −3.86 to −0.46]), and motor (aMD, −1.40 [95% CI, −2.60 to −0.20]) performance. The other 27 secondary outcomes did not show any significant differences between groups. Prophylactic oral 40% dextrose gel at 1 hour of age versus placebo resulted in no significant difference in the incidence of neurosensory impairment at 2 years corrected age among late preterm and term children born at risk of neonatal hypoglycemia.
Reference:jamanetwork.com/journals/jama/article-abstract/2790286
