An Analgesic Technique for Orogastric Tube Insertion in Newborns: DOLATSONG, a Randomized Multicentric Controlled Trial.

BACKGROUND: Gastric tube insertion is necessary to support early enteral feeding of newborns during their neonatal intensive care stay. This frequent and invasive procedure is known to be painful. Very few analgesic techniques (sweet solutions, sucking, swaddling, and skin-to-skin contact) are available to reduce the pain caused by orogastric tube insertion procedure. OBJECTIVE: To determine whether a new orogastric tube insertion technique modifies the pain response in newborns, we hypothesize that inserting an orogastric tube through the nipple of a bottle reduces pain caused by this procedure. DESIGN: Prospective, controlled, randomized, multicentered and open label study. SETTINGS: Three neonatal intensive care units in France (2 level 3 units and 1 level 2B). PARTICIPANTS: Full-term or premature newborns at 32 weeks of gestation or more, postnatal age between 48 hours and 21 days, not ventilated and requiring enteral feeding, were randomized into 2 groups: usual technique (n = 36) and experimental technique (n = 35). METHODS: Our experimental technique was to insert the orogastric tube through a modified nipple of a bottle. This method was compared with the usual technique of inserting the tube directly into the newborn's mouth without a support to guide it accompanied by a nipple encouraging sucking with a nonnutritive solution. An association of nonnutritive sucking and orally administered 30% glucose was given to all children for analgesic purposes. Pain during the orogastric tube insertion was assessed on video recordings by 2 independent experts, using a heteroassessment behavioral scale for pain (DAN-Douleur Aiguë du Nouveau-né; APN-Acute Pain in Newborns). The primary outcome was an Acute Pain in Newborns score of less than 3 at the time of the procedure. Comparisons were made using Fisher exact test or Mann-Whitney U test. Factors associated with an Acute Pain in Newborns score of 3 and greater were explored using univariable and multivariable regression models. RESULTS: All but 1 video recording in each group were analyzed. Among the 34 neonates in the experimental group, 71.4% (95% CI: [53.7-85.4]) had an Acute Pain in Newborns score of less than 3 during orogastric tube insertion versus 41% (95% CI: [27.9-61.9]) in the control group (P = .031). Gagging was frequent and nonsignificantly different between the 2 groups (69% in the control group, 51% in the experimental group, P = .13). In multivariable analysis, the experimental technique was an independent factor of pain prevention compared with the usual technique (odds ratio = 0.21 [0.06-0.71], P = .015). CONCLUSIONS: This study suggests that a simple, inexpensive, and feasible technique of orogastric tube insertion through the nipple of a bottle limits pain associated with this procedure in newborns.

Prescription of Aminoglycosides in 23 French Neonatal Intensive Care Units.

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 < 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.

Characteristics of prescription in 29 Level 3 Neonatal Wards over a 2-year period (2017-2018). An inventory for future research.

OBJECTIVES: The 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 METHODS: The 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. RESULTS: The 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) (p<0.0001). In addition, 69.2% of the 351 different combinations of an medication INN and a route of administration have no indication for the first month of life according to the French SmPC. Ninety-five percent of premature infants with GA less than 32 weeks received at least one medication not cited in SmPC. CONCLUSION: Neonates remain therapeutic orphans. The consequences of polypharmacy in L3NW should be quickly assessed, especially in the most immature infants.