Safety of a Triple-chamber Bag Parenteral Nutrition in Children Ages up to 24 Months: An Observational Study.

OBJECTIVES: Hypermagnesemia has been reported in preterm neonates treated with commercial pediatric triple-chamber bag (3CB) parenteral nutrition (PN). This postmarketing study was requested by the European Medicines Agency to assess the safety of a 3CB PN product in full-term neonates and children up to 24 months of age. METHODS: This prospective, multicenter, observational study enrolled hospitalized, full-term, newborn infants and children up to 24 months of age receiving >70% of nutrition as PN and requiring ≥50% of nutrition as PN for ≥5 days. All patients received 3CB PN during the study for ≤15 days. The primary outcome was serum magnesium, summarized by age group (0-1, >1-12, and >12-24 months). Secondary outcomes were nutritional intake and adverse events (AEs), including clinically significant abnormal laboratory results and vital signs. RESULTS: A total of 102 eligible patients were included. Median (interquartile range) parenteral magnesium intake was 0.23 (0.18-0.30) mmol ·â€Škg ·â€Šday. Mean serum magnesium showed no consistent changes during treatment in any age group. One moderate and 3 mild AEs of hypermagnesemia were reported in 4 patients (3.9%), all ages 0 to 1 month. Other AEs in >2 patients were hypertriglyceridemia (6.9%), laryngitis (3.9%), hyperkalemia, hypokalemia, hyponatremia, hypophosphatemia, and neonatal hypotension (each 2.9%). Other serum electrolytes were stable, and revealed no safety concerns. CONCLUSIONS: Mean serum magnesium levels were not affected by 3CB PN in full-term neonates and children up to 24 months of age. The risk of hypermagnesemia AEs was low when providing median parenteral magnesium of 0.2 to 0.3 mmol ·â€Škg ·â€Šday in this population.

Benefits of a new pediatric triple-chamber bag for parenteral nutrition in preterm infants.

OBJECTIVES: The aim of this study was to evaluate the efficacy, safety, flexibility, and ease of handling and use of the Ped3CB-A 300  mL, the first ready-to-use multichamber parenteral nutrition (PN) system, with optional lipid bag activation, specially designed for administration to preterm infants. MATERIALS AND METHODS: In this prospective, open-label, multicenter, noncomparative, phase III clinical trial, preterm infants were treated with Ped3CB-A for 5 to 10 consecutive days. RESULTS: A total of 113 preterm infants were enrolled in the study and 97 (birth weight 1382 ±â€Š520 g; gestational age 31.2 ±â€Š2.5 weeks; postnatal age administration 5.6 ±â€Š6.1 days) were included in the per protocol analysis accounting for 854 perfusion days. Double-chamber bag activation was used for 32 perfusion days. Macronutrient, electrolyte, and mineral supplements were primarily administered through a Y-line or directly in the activated bag. In all, 199 additions (mainly sodium, 95%) were made to the Ped3CB-A bags on 197 infusion days (23.1%) in 43 infants (44.3%). More than 1 of these nutrients was added to the bag on only 1 perfusion day. Mean and maximum parenteral nutrient intakes were 2.8 ±â€Š0.7 and 3.6 ±â€Š0.8  g amino acids per kilogram per day, and 80 ±â€Š20 and 104 ±â€Š22  kcal · kg(-1) · day(-1). Mean weight gain represented 10.0, 21.5, and 22. 6 g · kg(-1) · day(-1) according to age at inclusion (0-3, 4-7, or >7 days of life). A visual analog scale was completed and produced positive results. No adverse events were attributable to the design of the Ped3CB-A system. CONCLUSIONS: Ped3CB-A provides easy-to-use, well-balanced, and safe nutritional support. Nutritional intakes and weight gain were within the recent PN recommendations in preterm infants.

Technical recommendations and interpretation guidelines for electroencephalography for premature and full-term newborns.

Electroencephalography (EEG) of neonatal patients is amongst the most valuable diagnostic and prognostic tool. EEG recordings, acquired at the bedside of infants, evaluate brain function and the maturation of premature and extremely premature infants. Strict conditions of acquisition and interpretation must be respected to guarantee the quality of the EEG and ensure its safety for fragile children. This article provides guidance for EEG acquisition including: (1) the required equipment and devices, (2) the modalities of installation and asepsis precautions, and (3) the digital signal acquisition parameters to use during the recording. The fundamental role of a well-trained technician in supervising the EEG recording is emphasized. In parallel to the acquisition recommendations, we present a guideline for EEG interpretation and reporting. The successive steps of EEG interpretation, from reading the EEG to writing the report, are described. The complexity of the EEG signal in neonates makes artefact detection difficult. Thus, we provide an overview of certain characteristic artefacts and detail the methods for eliminating them.

Normal EEG during the neonatal period: maturational aspects from premature to full-term newborns.

Electroencephalography (EEG) is the reference tool for the analysis of brain function, reflecting normal and pathological neuronal network activity. During the neonatal period, EEG patterns evolve weekly, according to gestational age. The first analytical criteria for the various maturational stages and standardized neonatal EEG terminology were published by a group of French neurophysiologists training in Paris (France) in 1999. These criteria, defined from analog EEG, were completed in 2010 with digital EEG analysis. Since then, this work has continued, aided by the technical progress in EEG acquisition, the improvement of knowledge on the maturating processes of neuronal networks, and the evolution of critical care. In this review, we present an exhaustive and didactic overview of EEG characteristics from extremely premature to full-term infants. This update is based on the scientific literature, enhanced by the study of normal EEGs of extremely premature infants by our group of neurophysiologists. For educational purposes, particular attention has been paid to illustrations using new digital tools.

RFT1-congenital disorder of glycosylation (CDG) syndrome: a cause of early-onset severe epilepsy.

RFT1-congenital disorder of glycosylation (CDG) syndrome, a recessive N-glycosylation disorder caused by mutation in the RFT1 gene, is a very rare subtype of CDG syndrome associated with deafness, developmental delay, and non-specific epilepsy. The aim of this report is to describe the electroclinical presentation of epilepsy associated with this condition. [Published with video sequences online].