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Objectives: No consensus exists about the doses of analgesics, sedatives, anesthetics, and paralytics used in critically ill neonates. Large-scale, detailed pharmacoepidemiologic studies of prescription practices are a prerequisite to future research. This study aimed to describe the detailed prescriptions of these drug classes in neonates hospitalized in neonatal intensive care units (NICU) from computerized prescription records and to compare prescriptions by gestational age.Materials and Methods: We included all neonates requiring intensive care in 30 French level III units from 2014 through 2020 with a computerized prescription for an analgesic, sedative, anesthetic, or paralytic agent. We described frequencies of prescription, methods of administration, concomitant drug prescriptions, and dosing regimen, and compared them across gestational ages.Results: Among 65,555 neonates, 29,340 (44.8%) were prescribed at least one analgesic (acetaminophen in 37.2% and opioids in 17.8%), sedative (9.8%), anesthetic (8.5%), and/or paralytic agent (1%). Among preterm infants born before 28 weeks, 3,771/4,283 (88.0%) were prescribed at least one of these agents: 69.7% opioids, 41.2% sedatives, 32.5% anesthetics, and 5.8% paralytics. The most frequently prescribed agents were sufentanil (in 10.3% of neonates) and morphine (in 8.0% of neonates) for opioids, midazolam (9.3%) for sedatives, ketamine (5.7%) and propofol (3.3%) for anesthetics. In most neonates, opioids and sedatives were prescribed as continuous infusion, whereas anesthetics were prescribed as single doses. Opioids, sedatives and paralytics were mostly prescribed in association with another agent. Doses varied significantly by gestational age but within a limited range. Gestational age was inversely related to the frequency, cumulative dose and duration of prescriptions. For example, morphine prescriptions showed median (IQR) cumulative doses of 2601 (848–6750) vs. 934 (434–2679) µg/kg and median (IQR) durations of 7 (3–15) vs. 3 (2–5) days in infants born p-valueConclusion: The prescriptions of analgesic, sedative, anesthetic, or paralytic agent were frequent and often combined in the NICU. Lower gestational age was associated with higher frequencies, longer durations and higher cumulative doses of these prescriptions. Dose-finding studies to determine individualized dosing regimens and studies on long-term neurodevelopmental outcome according to received cumulative doses are required.

Background: Aminoglycosides are the most prescribed antibiotics in neonatal intensive care units (NICU). Reducing exposure to antibiotics in the NICU is highly desirable, particularly through benchmarking methods. Methods: Description of aminoglycosides prescriptions in 23 French NICU using the same computerized system over a 4-year period (2017–2020). A benchmarking program of antibiotics prescription was associated. Results: The population included 53,818 patients. Exposition rates to gentamicin and amikacin were 31.7% (n = 17,049) and 9.1% (n = 4894), respectively. Among neonates exposed to gentamicin, 90.4% of gentamicin and 77.6% of amikacin treatments were started within the 1st week of life. Among neonates exposed to amikacin, 77.6% started amikacin within the 1st week. The average daily dose of gentamicin at first prescription increased over the study period from 3.9 in 2017 to 4.4 mg/kg/d in 2020 (p &lt, 0.0001). Conversely, the corresponding amikacin daily doses decreased from 13.0 in 2017 to 12.3 mg/kg/d in 2020 (p = 0.001). The time interval between the first 2 doses of gentamicin was mainly distributed in 3 values during the first week of life: 49.4% at 24 h, 26.4% at 36 h, and 22.9% at 48 h. At first amikacin prescription, the time interval was distributed in 4 categories: 48% at 24 h, 4.1% at 30 h, 8.5% at 36 h, and 37.1% at 48 h. As compared to literature guidelines, the rates of overdose and underdose in gentamicin (1.5% and 2.7%) and amikacin (0.3% and 1.0%). They significantly decreased for gentamicin over the study period. In multivariate analysis, the factors significantly associated with GENT overdose were the year of admission, prematurity, length of stay, and duration of the treatment. Conclusion: This prescription strategy ensured a low rate of overdose and underdose, and some benefits of the benchmarking program is suggested.

Introduction: Prescribing antibiotics to newborns is challenging, as excess antibiotics are a risk factor for increased morbidity and mortality. The objective of this study was to describe the evolution of antibiotic exposure over three years in a large network of level 3 neonatal wards where each center is informed yearly of its own results and the results of other centers and has full autonomy to improve its performance.Patients and Methods: This is a prospective, observational study of antibiotics prescriptions over the 2017–2019 period in a network of 23 French level 3 neonatal wards. The network relied on an internal benchmarking program based on a computerized prescription ordering system. Among others, antibiotics exposure, treatment duration, and antibiotics spectrum index were analyzed.Results: The population consisted of 39,971 neonates (51.5% preterm), 44.3% of which were treated with antibiotics. Of the treated patients, 78.5% started their first antibiotic treatment in the first three days of life. Antibiotic exposure rate significantly declined from 2017 to 2019 (from 46.8% to 42.8%, p < 0.0001); this decline was significant in groups with gestational age >26 weeks, but not in the group with extremely low gestational age Conclusion: This study showed that a strategy characterized by the collection of information via a computerized order-entry system, analysis of the results by a steering committee representative of all neonatal wards, and complete autonomy of neonatal wards in the choice of prescription modalities, is associated with a significant reduction in the use of antibiotics in newborns with gestational age greater than 26 weeks.

International audience; To describe the exposure to drugs used for the treatment of patent ductus arteriosus (PDA) in a large cohort of preterm infants born before 32 weeks of gestation. METHODS: A prospective observational cohort analysis was conducted during 2 years in 28 French level 3 NICU using the same computerized order-entry system. The main outcome was "a medically treated PDA," defined as exposure to ibuprofen, indomethacin, or paracetamol prescribed with the indication of PDA closure. Secondary outcomes were as follows: time of the first treatment administration; total exposure to furosemide during hospitalization; and rate of PDA refractory to pharmacological closure. RESULTS: The study cohort consisted of 2614 infants. Among them, 474 (18.1%) received a medical treatment for PDA, with a mean postnatal age at treatment of 4.3 ± 6.6 days. The drug used as a first-line treatment was ibuprofen in 89.5% and paracetamol in 10.5%. One hundred and ninety-five infants (7.4%) had a PDA refractory to pharmacological closure. At the multivariate analysis, factors associated with PDA refractory to pharmacological closure (OR; 95% CI) were as follows: gestational age (GA) (0.81; 0.72-0.90), paracetamol as the first-line treatment (0.32; 0.15-0.68), and pharmacological treatment before 48 h of life (0.63; 0.43-0.94). 24.6% of the study cohort was exposed to furosemide (cumulative dose 6.5 ± 12.6 mg/kg). Variables significantly associated with higher cumulative doses of furosemide were lower GA and ibuprofen treatment (both p

ObjectivesThe primary objective of this study is to determine the current level of patient medication exposure in Level 3 Neonatal Wards (L3NW). The secondary objective is to evaluate in the first month of life the rate of medication prescription not cited in the Summary of Product Characteristics (SmPC). A database containing all the medication prescriptions is collected as part of a prescription benchmarking program in the L3NW.Material and methodsThe research is a two-year observational cohort study (2017-2018) with retrospective analysis of medications prescribed in 29 French L3NW. Seventeen L3NW are present since the beginning of the study and 12 have been progressively included. All neonatal units used the same computerized system of prescription, and all prescription data were completely de-identified within each hospital before being stored in a common data warehouse.ResultsThe study population includes 27,382 newborns. Two hundred and sixty-one different medications (International Nonproprietary Names, INN) were prescribed. Twelve INN (including paracetamol) were prescribed for at least 10% of patients, 55 for less than 10% but at least 1% and 194 to less than 1%. The lowest gestational ages (GA) were exposed to the greatest number of medications (18.0 below 28 weeks of gestation (WG) to 4.1 above 36 WG) (pConclusionNeonates remain therapeutic orphans. The consequences of polypharmacy in L3NW should be quickly assessed, especially in the most immature infants.

The efficacy of palivizumab prophylaxis after bronchopulmonary dysplasia (BPD) has been demonstrated in a single placebo-controlled trial. Concern has emerged about the degree of efficacy of palivizumab. This study was designed to determine the efficacy of administration of palivizumab to premature infants with a gestational age/=32 weeks, a past history of BPD and younger than 6 months of age at the start of the epidemic.Prospective observational study of respiratory syncytial virus (RSV) bronchiolitis requiring hospitalization in Burgundy (12 hospitals) from December 1 to April 30 of the next year during 3 successive epidemic seasons (1999-2000, 2000-2001 and 2001-2002). The regional perinatal database provided perinatal epidemiologic characteristics of the population as a whole and of cohorts of children at risk for severe RSV infection born between April 15 and January 31 of the following year. Palivizumab was used in the 2000-2001 and 2001-2002 periods only.The 3 epidemics included respectively 377, 310 and 328 children born during April 15 to January 31 of the following year. The 3 epidemics differed significantly by the proportion of severely premature infants with BPD (3.2% versus 0.7 and 0.3%). In the cohort of severely premature infants with BPD born in 1999-2000, 2000-2001 and 2001-2002, the hospitalization rate for RSV bronchiolitis decreased significantly from 12 of 26 to 2 of 17 and 1 of 26 (46.2% versus 11.8 and 3.8%; P0.01). Sixteen of 17 and 23 of 26 premature infants with a gestational age/=32 weeks and with BPD had been treated with palivizumab in the years 2000-2001 and 2001-2002.This study strongly supports the efficacy of prevention of RSV bronchiolitis by palivizumab in severely premature infants with BPD.

Few prospective population-based studies of respiratory diseases have been conducted in term neonates. We aimed to describe mechanically ventilated respiratory disorders in term neonates and associated risk factors in a regional-based study of livebirths between 37 and 41 weeks. The study was prospective for epidemiological data recording, and retrospective for collecting additional data from charts of neonates with severe (mechanically ventilated) respiratory disorders. A total of 14,813 neonates with gestational age (GA) 37-38 weeks and 50,187 neonates with GA 39-41 weeks were included. The overall incidences (per thousand livebirths) of mechanically ventilated transient tachypnoea of the newborn (TTN) respiratory distress syndrome (RDS) and meconium aspiration syndrome (MAS) were 0.72 per thousand[95% CI 0.53 per thousand, 0.96 per thousand], 0.38 per thousand[95% CI 0.25 per thousand, 0.57 per thousand] and 0.61 per thousand[95% CI 0.44 per thousand, 0.84 per thousand], respectively. Increasing GA from 37 to 41 weeks was associated with a significant decrease in incidence of RDS and TTN without any significant change for MAS. Multivariable analysis was used to identify independent factors associated with severe respiratory disorders: in the 37-38 weeks group - Apgar score < or =3 at 1 min, elective caesarean section (CS), emergency CS and placental abruption; in the 39-41 weeks group - Apgar score < or =3 at 1 min, elective CS, emergency CS, meconium-stained amniotic fluid and abnormal cardiotocography. Comparing the population attributable risks, the main risk factor of severe respiratory disorders was elective CS in the 37-38 weeks group and meconium-stained amniotic fluid in the 39-41 weeks group.

The extensive use of broad-spectrum antibiotics has been associated with major changes in the spectrum of organisms involved in early-onset neonatal infection (EONI), their susceptibility to antibiotics, or both. Therefore, guidelines for a more rational use of antibiotics in neonates have been developed. We conducted a population-based observational study to assess the effectiveness and compliance with restrictive guidelines for the antibiotic therapy in EONI.Neonates receiving antibiotics within 72 hours of life were identified prospectively by population-based surveillance in the 18 hospitals of Burgundy, between February 2002 and June 2003. They were treated in accordance with guidelines limiting the use of broad-spectrum antibiotics and shortening the treatment duration. Each neonate included was evaluated for 60 days after birth. An unfavorable outcome was defined as death related to EONI or late-onset infection.Of the 25,480 infants born during the study period, 1012 received antibiotics at birth. Of these 1012 infants, 39 were definitely infected (septicemia), 288 clinically infected and 685 not infected. The EONI cure rate was 96.8% without infectious relapse. Forty-five infants received a second course of antibiotic therapy. Birth weight (OR: 5.6; 95% CI: 2.2-14.1), mechanical ventilation (OR: 4.1; 95% CI: 1.3-13.1), central venous catheterization (OR: 16.1; 95% CI: 1.8-141.9), and antibiotic therapy duration (OR: 2.5; 95% CI: 1.1-5.5) were independently associated with late-onset infection.Reducing the antibiotic therapy duration does not increase the risk of infectious relapse and may decrease the incidence of late-onset infection.

The present study was designed to determine the efficacy of administration of palivizumab to preterm infants with gestational age (GA) ≤30 weeks without bronchopulmonary dysplasia (BPD). All patients born with GA ≤30 weeks without BPD on Day 28 and hospitalized for RSV bronchiolitis in Burgundy (12 hospitals) from December 1 to April 30 of the next year were included in this prospective observational study during five successive RSV seasons (1999–2000, 2000–2001, 2001–2002, 2002–2003, and 2003–2004). Palivizumab was given to premature infants with a gestational age ≤30 weeks without BPD in the 2002–2003 and 2003–2004 periods only. In the cohort of premature infants with GA ≤30 weeks without BPD, the respiratory syncytial virus (RSV) bronchiolitis hospitalization rate was reduced significantly (P

In France, the European health card was created in June 2004 to increase the quality of healthcare granted to european citizen anywhere in europe and to facilitate the reimbursement of the healthcare costs. The patient identifier included in this card is essentially based on the healthcare insurance number of the patient and does not allow any linkage with his (her) previous health care data if he (she) is affiliated to another national healthcare insurance system when working for a long duration outside France. The purpose of this paper is to present the concept of a personal identifier based on familial components which has been validated by the French authority for personal data protection in the framework of a genetic study. Results issued from the Burgundy perinatal network demonstrate the interest and the faisability of adding a maternal component to the individual component of the new-born to allow Mother/new-born healthcare data linkage after anonymization. The advantage of adding a familial component to the healthcare insurance number is debated. This proposal will permit to link the data of a patient even when residing outside his country in Europe. It will also contribute to establish european public health statistics by matching healthcare data of the patients' records with other administrative data (mortality, social information ..) after anonymisation of these data in accordance with the European directive on data protection.

Today, one of the main stake of the interfaced health information systems or networks is to be able to gather the different parts of the medical record of a patient without any risk to mix them with those of one other patient. This objective could appear easy to reach but only in theory because in practice many name are misspelled or erroneous and a great attention has to be paid to define what is the best identifier to link medical record. As a linkage using less informative identifiers could lead to linkage errors, it is essential to quantify the information associated to each identifier. The aim of this study was to estimate the discriminating power of different identifiers susceptible to be used in a record linkage process. This work showed the interest of three identifiers when linking data concerning a same patient using an automatic procedure based on the method proposed by Jaro; the date of birth, the first and the last names seemed to be the more appropriate identifiers. Including a poorly discriminating identifier like gender did not improve the results. Moreover, adding a second christian name, often missing, increased linkage errors. On the contrary, it seemed that using a phonetic treatment adapted to the French language could improve the results of linkage in comparison to the Soundex. However, whatever, the method used it seems necessary to improve the quality of identifier collection as it could greatly influence linkage results.

As a linkage using less informative identifiers could lead to linkage errors, it is essential to quantify the information associated to each identifier. The aim of this study was to estimate the discriminating power of different identifiers susceptible to be used in a record linkage process. This work showed the interest of three identifiers when linking data concerning a same patient using an automatic procedure based on the method proposed by Jaro; the date of birth, the first and the last names seemed to be the more appropriate identifiers. Including a poorly discriminating identifier like gender did not improve the results. Moreover, adding a second christian name, often missing, increased linkage errors. On the contrary, it seemed that using a phonetic treatment adapted to the French language could improve the results of linkage in comparison to the Soundex. However, whatever, the method used it seems necessary to improve the quality of identifier collection as it could greatly influence linkage results.