Individualised versus standard duration of antibiotic therapy in children with acute uncomplicated febrile urinary tract infection: a study protocol and statistical analysis plan for a multicentre randomised clinical trial.

INTRODUCTION: Febrile urinary tract infection is one of the most common bacterial infections in children. Currently, recommended antibiotic duration is 10 days. However, recent evidence suggests that 90%-95% of children with febrile urinary tract infections are afebrile and clinically improved 48-72 hours after treatment initiation. Accordingly, individualised duration of antibiotic therapy, according to the recovery time, might be more beneficial than current recommendations, but no evidence exists. METHODS AND ANALYSIS: An open-label randomised clinical trial equally randomising children aged 3 months to 12 years from eight Danish paediatric departments with uncomplicated febrile (≥38°C) urinary tract infection to either individualised or standard duration of antibiotic therapy. Children allocated to individualised duration of antibiotic therapy will terminate antibiotic therapy 3 days after clinical improvement with no fever, flank pain or dysuria. Children allocated to standard duration will receive 10 days of antibiotic therapy. Co-primary outcomes are non-inferiority for recurrent urinary tract infection or death within 28 days after the end of treatment (non-inferiority margin 7.5 percentage points) and superiority for the number of days with antibiotic therapy within 28 days after treatment initiation. Seven other outcomes will also be assessed. A total of 408 participants are needed to detect non-inferiority (one-sided alpha 2.5%; beta 80%). ETHICS AND DISSEMINATION: This trial has been approved by the Ethics Committee (H-21057310) and the Data Protection Agency (P-2022-68) in Denmark. Regardless of the trial's findings (whether positive, negative or inconclusive), the results will be compiled into one or more manuscripts for publication in international peer-reviewed scientific journals and presented at conferences. TRIAL REGISTRATION NUMBER: NCT05301023.

Children with acute pyelonephritis need medical re-evaluation when home-treated with oral antibiotics.

AIM: To investigate the efficacy and safety of home-treatment with oral piv-mecillinam or amoxicillin-clavulanate in children with acute pyelonephritis. METHODS: Children aged over 6 months diagnosed with culture confirmed pyelonephritis at Danish Paediatric Departments were home-treated with piv-mecillinam (tablets) or amoxicillin-clavulanate (liquid or tablets). Follow-up was performed by phone (second treatment day) and clinical review of the patients in the hospital (day three). RESULTS: Four hundred eighteen children were included. In total, 333/418 (80%) responded well to the initial oral antibiotic treatment. 85/418 (20%) were changed to another treatment of these 47/418 (11%) to a second-line oral antibiotic and 38/418 (9%) to intravenous antibiotics due to insufficient clinical improvement or bacterial resistance. Bacterial resistance was similar for piv-mecillinam and amoxicillin-clavulanate: 4/74 (5%) versus 33/333 (10%) (p = 0.22). Insufficient clinical improvement, despite no resistance, primarily occurred in children treated with piv-mecillinam: 16/74 (22%) versus 28/344 (8%) (p < 0.001), and predominantly occurred in piv-mecillinam treated children <5 years: 7/20 (35%) versus 9/54 (17%) (p < 0.05), potentially because of problems with piv-mecillinam tablets. In the study population no cases of death or septicemia developed after start of initial oral treatment. CONCLUSION: A home-treatment regime for pyelonephritis in children >6 months is safe; however, during treatment, clinical re-evaluation is required as in 20% of cases a change in treatment was necessary.

Successful paediatric renography does not require sedation.

INTRODUCTION: Sedation is often used to optimise ren-ography in children < 3 years, but it requires continuous monitoring. METHODS: We discontinued routine use of chloral hydrate sedation of patients undergoing renography, and introduced that children < 2 years were placed in a child immobiliser for nuclear examinations at the Department of Paediatrics before being transported for renography. In addition, children < 3 years were offered melatonin, which is not a sedative. Chloral hydrate was given only if parents wanted sedation. We analysed the results from a consecutive series of patients undergoing renography from August 2010 to December 2015 and compared data from those who had been administered choral hydrate sedation with those who had received no sedation. RESULTS: Renography was unaccomplished in 10% (3/30) of the choral hydrated sedated children and in 11% (54/512) of the non-sedated children (p = 0.83). Uncooperative children resulted in failed renography in 0% (0/3) and 39% (21/54) of cases, respectively (p = 0.46). Patients placed in a child immobiliser at the Department of Paediatrics had the greatest probability of achieving successful renography (p = 0.0013), the shortest renography procedure duration irrespective of melatonin use (p = 0.0001) and the lowest risk of a procedure duration > 60 minutes (p = 0.0004). CONCLUSIONS: Renography can be performed without sedation. We recommend that children < 2 years be placed in a child immobiliser at the Department of Paediatrics before being transported for renography. Additional studies are needed to investigate the effects of melatonin. FUNDING: none. TRIAL REGISTRATION: not relevant.

Prognosis and risk factors for intrauterine growth retardation.

INTRODUCTION: Intrauterine growth retardation (IUGR) is the term describing a foetus that has not reached its genetic growth potential. There is no international consensus on the definition of IUGR. The aim of this study was to describe a cohort of weight-restricted neonates and their mothers focusing on risk factors, catch up and neonatal outcome. MATERIAL AND METHODS: This was a retrospective descriptive study of IUGR neonates with a birth weight below 70% of the expected whose mothers were admitted to the Neonatal Ward at Hvidovre Hospital during 2007-2009. Obstetrical and maternal risk factors and neonatal growth and outcome at six weeks, five months and 12 months of age were collected. RESULTS: A total of 73 neonates and their mothers were included. Caesarean delivery was given in 78% of the cases. Maternal risk factors included gestational hypertension (33%), smoking (24%) and placental infarction (17%). Hypoglycaemic episodes developed in 31% of the neonates. At 12 months, 90% had caught up growth and 7% had a neurologically poor outcome. No infants died. CONCLUSION: Maternal smoking and gestational hypertension are important risk factors for the development of IUGR. Special attention must be given to reducing the risk of hypoglycaemia. More studies are needed. Our purpose was to underline the need for a consensus on the definition of IUGR, catch-up and follow-up programmes in order to compare results in the future. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.