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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, SCOPUS: ar.j, DecretOANoAutActif, info:eu-repo/semantics/published

Introduction Feeding strategies are critical for healthy growth in preterm infants. Bile salt-stimulated lipase (BSSL), present in human milk, is important for fat digestion and absorption but is inactivated during pasteurization and absent in formula. This study evaluated if recombinant human BSSL (rhBSSL) improves growth in preterm infants when added to formula or pasteurized breast milk. Patients and Methods LAIF (Lipase Added to Infant Feeding) was a randomized, double-blind, placebo-controlled phase 3 study in infants born before 32 weeks of gestation. The primary efficacy variable was growth velocity (g/kg/day) during 4 weeks intervention. Follow-up visits were at 3 and 12 months. The study was performed at 54 centers in 10 European countries. Results In total 415 patients were randomized (rhBSSL n = 207, placebo n = 208), 410 patients were analyzed (rhBSSL n = 206, placebo n = 204) and 365 patients were followed until 12 months. Overall, there was no significantly improved growth velocity during rhBSSL treatment compared to placebo (16.77 vs. 16.56 g/kg/day, estimated difference 0.21 g/kg/day, 95% CI [-0.40; 0.83]), nor were secondary endpoints met. However, in a predefined subgroup, small for gestational age infants, there was a significant effect on growth in favor of rhBSSL during treatment. The incidence of adverse events was higher in the rhBSSL group during treatment. Conclusions Although this study did not meet its primary endpoint, except in a subgroup of infants small for gestational age, and there was an imbalance in short-term safety, these data provide insights in nutrition, growth and development in preterm infants.

Objectives: Preterm infants often experience suboptimal growth, which can affect organ development. The aim of this study was to improve growth by treatment with bile salt-stimulated lipase (BSSL), naturally present in breast milk, but lost after pasteurization, and absent in formula. Methods: Two clinical trials were performed with a predefined analysis of combined data to investigate the effects of recombinant human BSSL (rhBSSL) treatment on growth velocity and fat absorption in preterm infants. The studies were randomized and double-blinded comparing 7-day treatment with rhBSSL and placebo, administered in pasteurized breast milk or formula, using a crossover design. Results: Sixty-three infants were evaluated for safety. At randomization, the mean (standard deviation) weight was 1467 (193) g and mean postmenstrual age was 32.6 (0.5) weeks. Sixty and 46 infants were evaluated for growth velocity and fat absorption, respectively. rhBSSL treatment significantly improved mean growth velocity by 2.93 g.kg(-1).day(-1) (P<0.001) compared with placebo (mean 16.86 vs 13.93 g.kg(-1).day(-1)) and significantly decreased the risk of suboptimal growth (<15 g.kg(-1).day(-1)) (30% vs 52%, P = 0.004). rhBSSL significantly increased absorption of the long-chain polyunsaturated fatty acids, docosahexaenoic acid, and arachidonic acid by 5.76% (P = 0.013) and 8.55% (P = 0.001), respectively, but had no significant effect on total fat absorption. The adverse-event profile was similar to placebo. Conclusions: In preterm infants fed pasteurized breast milk or formula, 1 week of treatment with rhBSSL was well tolerated and significantly improved growth and long-chain polyunsaturated fatty acid absorption compared to placebo. This publication presents the first data regarding the use of rhBSSL in preterms and the results have led to further clinical studies.

SCOPUS: le.j, info:eu-repo/semantics/published

With the global increase in human immunodeficiency virus 1 (HIV-1) infection in women of childbearing age, there has also been an alarming increase in the number of mother-to-child transmissions of HIV-1. Although antiretroviral therapy and Cesarian section have been demonstrated to significantly decrease the vertical transmission rate of, these interventions are not widely available in the developing world. Therefore, studies of the mechanisms of vertical transmission are important. This thesis was based on a prospective follow-up of HIV-1-infected patients, especially mothers and children in Sweden and in Cameroon. Coreceptor usage of the primary HIV-1 isolates was determined on indicator cell lines U87.CD4 and/or GHOST(3) engineered to express CD4 and one of the main chemokine receptors (CCR1, CCR2b, CCR3, CCR5, CXCR4, Bob and Bonzo). The genetic subtype of the viruses was determined by phylogenetic analysis of DNA sequences or by heteroduplex mobility assay (HMA). Coreceptor usage of 81 primary HIV-1 isolates was analysed in relation to their biological phenotype, the genetic subtype and the severity of HIV-1 infection in adult patients. In all cases, tropism for MT-2 cells, a previously used indicator cell line, correlated with CXCR4 usage. Importantly, we found subtype-dependent differences in coreceptor usage, in that dual tropic R5M viruses were detected less frequently among subtype D isolates and that CXCR4 use was less frequent among subtype C isolates. Coreceptor usage of primary HIV-1 isolates obtained from Cameroonian pregnant women was also tested. HIV-1 mother-to-child transmission rate was 11.9%. The majority of the virus isolates were of envelope subtype A and used CCR5 as coreceptor for cell entry. Four isolates of 28 (14.2%) were able to use the orphan receptor Bonzo as well. In two mothers (of four tested) who transmitted HIV-1 to their children, virus with CCR5 Bonzo dual tropism emerged during pregnancy. Paired isolates from mother and child w