Retrospective evaluation of a national guideline to prevent neonatal hypoglycemia

Hypoglycemia is common in neonates and may cause adverse neurological outcomes. Guidelines should aim to prevent repeated hypoglycemic episodes in risk groups, but they are not usually stratified according to the severity of hypoglycemia risk, which may lead to inappropriate and redundant interventions. We evaluated the effect of a national prevention guideline stratified according to mild, moderate, and severe risks of hypoglycemia. Methods: From national registers, a population cohort of 22,725 neonates was identified retrospectively before and after implementation of a national guideline. Of these, 1900 had World Health Organization International Classification of Diseases 10 discharge diagnoses of hypoglycemia. Diagnoses indicating hypoglycemia risk [small/large for gestational age (SGA/LGA), asphyxia, prematurity, maternal insulin-treated diabetes mellitus] were recorded. Neonatal ward files were evaluated to validate hypoglycemia diagnoses. Adjusted odds ratios (aORs) were calculated, adjusting for sex, parity, SGA, LGA, preterm birth, and asphyxia, where relevant. Results: Primiparity and male sex were associated independently with hypoglycemia diagnosis [aORs, 1.29 (1.17–1.42) and 1.14 (1.03–1.26), respectively]. Overall incidence of hypoglycemia at discharge decreased from 9.4% to 5.5% after guideline implementation [aORchange, 0.57 (0.50–0.64)]. Overall incidence of validated hypoglycemia decreased from 2.1% to 1.2% [aOR 0.59 (0.46–0.77), p<0.001]. By risk group, the hypoglycemia incidence decreased from 30.5% to 18.6% [aOR 0.52 (0.36–0.75)] among SGA neonates, from 25.8% to 16.4% [aOR 0.57 (0.42–0.76)] among preterm infants, and from 27.4% to 16.6% [aOR 0.63 (0.34–0.83)] among those with asphyxia. LGA neonates showed a decreased incidence in obstetric wards only. No significant change was observed for the diabetes group. Conclusion: Stratification of hypoglycemia risk in a hypoglycemia prevention guideline was followed by decreased estimated hypoglycemia incidence, but no causative conclusion could be drawn. Prospective studies with risk stratification for hypoglycemia prevention are encouraged

Oral-only antibiotics for bone and joint infections in children: study protocol for a nationwide randomised open-label non-inferiority trial

Introduction Children with bone and joint infections are traditionally treated with intravenous antibiotics for 3–10 days, followed by oral antibiotics. Oral-only treatment has not been tested in randomised trials.Methods and analysis Children (3 months to 18 years) will be randomised 1:1 with the experimental group receiving high-dose oral antibiotics and the control group receiving intravenous antibiotics with a shift in both groups to standard oral antibiotics after clinical and paraclinical improvement. Children in need of acute surgery or systemic features requiring intravenous therapy, including septic shock, are excluded. The primary outcome is defined as a normal blinded standardised clinical assessment 6 months after end of treatment. Secondary outcomes are non-acute treatment failure and recurrent infection. Outcomes will be compared by a non-inferiority assumption with an inferiority margin of 5%.Ethics and dissemination The trial has the potential to reduce unnecessary hospitalisation and use of intravenous antibiotics in children with bone or joint infections. Due to the close follow-up, exclusion of severely ill children and predefined criteria for discontinuation of the allocated therapy, we expect the risk of treatment failure to be minimal.Trial registration number NCT04563325