ABSTRACT
BACKGROUND: Despite the French pregnancy prevention program (PPP), a considerable number of pregnancies are potentially exposed to oral isotretinoin. New measures were taken by the French Medicines Agency, including the restriction of initial isotretinoin prescriptions to dermatology specialists in May 2015 and a new information campaign on teratogenicity in January 2019. OBJECTIVES: The aims were to: describe, between 2014 and 2021, compliance with PPP recommendations: isotretinoin use as a second-line treatment, first prescription by a dermatology specialist, monthly prescription renewal and pregnancy testing (PT); assess the effect of the 2015 and 2019 measures on PT compliance; and identify the determinants of PT noncompliance. METHODS: A retrospective cohort study was conducted among women aged 11-50 years initiating isotretinoin between 2014 and 2021 using the French Health Data System. PT compliance corresponded to pregnancy test completion and specific delays between prescription and dispensation. Time series analyses were performed to evaluate the effect of the 2015 and 2019 measures on PT compliance, and log-binomial and Poisson multivariate regression models were used to identify the determinants of PT noncompliance. RESULTS: Isotretinoin was prescribed as a second-line treatment in 64% of initiations, mainly by dermatology specialists (92%). A new monthly prescription was observed in 98% of dispensations. PT compliance reached 61%, 72% and 25% at initiation, renewals and end of treatment, respectively. The 2015 measure was associated with better PT compliance at initiation and renewals. The 2019 measure had no significant effect on PT compliance at the initiation or end of treatment but was associated with a decrease in PT compliance at renewals. Age, low socioeconomic level, initiation by a nondermatology specialist and during summer were associated with PT noncompliance. CONCLUSIONS: Understanding factors associated with PT noncompliance could help to target specific subpopulations of women treated with isotretinoin.
ABSTRACT
We sought to establish guidelines for hygiene care in newborns based on a systematic review of the literature and grading of evidence using the Groupe de Réflexion et d'Evaluation de l'Environement des Nouveau-nés (GREEN) methodology. We examined 45 articles and 4 reports from safety agencies. These studies recommend a tub bath (rather than a sponge bath) for full-term infants and a swaddle bath for preterm newborns. They also recommend against daily cleansing of preterm infants. The literature emphasized that hygiene care must consider the clinical state of the newborn, including the level of awareness and behavioral responses. Hospitalized newborns treated with topical agents may also experience high exposure to potentially harmful excipients of interest. Caregivers should therefore be aware of the excipients present in the different products they use. In high-resource countries, the available data do not support the use of protective topical agents for preterm infants.Conclusions: We recommend individualization of hygiene care for newborns. There is increasing concern regarding the safety of excipients in topical agents that are used in neonatology. A multidisciplinary approach should be used to identify an approach that requires lower levels of excipients and alternative excipients. What is known: ⢠Hygiene care is one of the most basic and widespread types of care received by healthy and sick newborns worldwide. ⢠There is no current guideline on hygiene for preterm or hospitalized term newborn. What is new: ⢠The French Group of Reflection and Evaluation of the environment of Newborns (GREEN) provided here guidelines based on the current body of evidence. ⢠Caregivers should be aware of the many issues related to hygiene care of newborns including newborns' behavioral responses to hygiene care, exposition to excipients of interest, and the potential risk of protective topical agents in a preterm infant. provided here guidelines based on the current body of evidence. ⢠Caregivers should be aware of the many issues related to hygiene care of newborns including newborns' possible behavioral responses to hygiene care, exposition to excipients of interest and the potential risk of protective topical agents in a preterm infant.
Subject(s)
Hygiene/standards , Infant Care/standards , Practice Guidelines as Topic , Administration, Topical , France , Humans , Infant, Newborn , Infant, Premature , Neonatology/methods , Skin Physiological PhenomenaABSTRACT
BACKGROUND: The experience of becoming the parent of a sick or premature newborn can be particularly distressing for parents. They often encounter challenges to the development of their parenting roles. Perception of the hospital stay has never been analyzed on a large scale. OBJECTIVE: To analyze parents' perception of their involvement in the care of their newborn. METHODS: An internet-based survey started in France in February 2014 on the basis of a validated questionnaire composed of 222 neonatal care-related items. A quantitative and qualitative analysis was performed on the items dealing with parents' involvement until August 2014. RESULTS: The survey was completed by 1500 parents, 98 % of whom were mothers. The infants had a mean GA of 32 weeks and a mean birth weight of 1600g. Parents rated their first care of their infant with mixed emotions (joy, stress, etc.). Parents were willing to practice new skills through guided participation, even for more complex care. Skin-to-skin care was only proposed after 7 days for 20 % of the parents; 10 % of the parents did not feel secure during this practice. The need for privacy and professional guidance was essential for meaningful skin-to-skin contact. DISCUSSION: Parents' perception of participating actively in their infant's care was positive and they felt guided by the nursing team. Most of them would have been more active with guidance. Skin-to-skin care was appreciated and desired, but could become stressful if the conditions were not optimal.
