Father's perceptions and care involvement for their very preterm infants at French neonatal intensive care units.

Objectives: We aimed to evaluate (1) fathers' perceptions and care involvement for their very premature infants and their views of the hospitalization period based on parental reports and (2) their evolution over time. Methods: We used an online parental survey to assess answers from parents of very preterm infants who were successfully discharged from French neonatal units. We analysed answers from February 2014 to January 2019 to an anonymous internet-based survey from the GREEN committee of the French Neonatal Society. Responses were compared for period 1 (P1, 1998 to 2013) and period 2 (P2, 2014 to 2019). Results: We analyzed 2,483 surveys, 124 (5%) from fathers and 2,359 (95%) from mothers. At birth, 1,845 (80%) fathers were present in the hospital, but only 879 (38%) were near the mother. The presence of fathers in the NICU increased from P1 to P2 (34.5% vs. 43.1%, p = 0.03). Nearly two thirds of fathers accompanied their infants during transfer to the NICU (1,204 fathers, 60.6%). Fathers and mothers had similar perceptions regarding relationships with caregivers and skin-to-skin contact with their infants. However, more fathers than mothers felt welcome in the NICU and in care involvement regarding requests for their wishes when they met their infant (79% vs. 60%, p = 0.02) and in the presentation of the NICU (91% vs. 76%; p = 0.03). Mothers and fathers significantly differed in the caring procedures they performed (p = 0.01), procedures they did not perform but wanted to perform (p < 0.001), and procedures they did not perform and did not want to perform (p < 0.01). Conclusion: Most fathers were present at the births of their very preterm infants, but fewer fathers were near the mother at this time. Less than two thirds of fathers accompanied their infants to the NICU. There should be further changes to better meet the specific needs of the fathers of infants requiring care in the NICU. Continuing assessment with an online questionnaire may be useful to monitor changes over time in father's involvement in NICUs.

Human Cytomegalovirus Infection Changes the Pattern of Surface Markers of Small Extracellular Vesicles Isolated From First Trimester Placental Long-Term Histocultures.

Extracellular vesicles (EVs) have increasingly been recognized as key players in a wide variety of physiological and pathological contexts, including during pregnancy. Notably, EVs appear both as possible biomarkers and as mediators involved in the communication of the placenta with the maternal and fetal sides. A better understanding of the physiological and pathological roles of EVs strongly depends on the development of adequate and reliable study models, specifically at the beginning of pregnancy where many adverse pregnancy outcomes have their origin. In this study, we describe the isolation of small EVs from a histoculture model of first trimester placental explants in normal conditions as well as upon infection by human cytomegalovirus. Using bead-based multiplex cytometry and electron microscopy combined with biochemical approaches, we characterized these small EVs and defined their associated markers and ultrastructure. We observed that infection led to changes in the expression level of several surface markers, without affecting the secretion and integrity of small EVs. Our findings lay the foundation for studying the functional role of EVs during early pregnancy, along with the identification of new predictive biomarkers for the severity and outcome of this congenital infection, which are still sorely lacking.

Early discharge and hospital-assisted home care is associated with better neurodevelopmental outcome in preterm infants.

AIMS: To compare hospital-assisted neonatal home care and standard hospital care for preterm newborns on neurodevelopment at 2 years corrected age, as well as duration of hospitalization, breastmilk rates, and readmissions before 1 year. METHODS: This observational study enrolled 415 inborn neonates <34+ 6 weeks that received home care (2008 to 2015) in the French University Hospital of Toulouse and 3186 neonates from the national cohort of infants discharged in 2011 that received standard hospital neonatal care (EPIPAGE 2). Neurodevelopment at 2 years was assessed with the Ages and Stages Questionnaire-3 (ASQ-3). RESULTS: At two years corrected age, infants in home care had 61% less risk of overall low ASQ ≤220 (OR = 0.4 [0.3-0.5], p < 0.001) and 31-80% less risk of low scores in four out of five domains compared to standard care. Home care was associated with shorter hospital stays (- 9 days; p < 0.001), higher breastmilk rates at final discharge (OR = 3.6 [2.8-4.6], p < 0.001 for singletons and OR = 2.3 [1.6-3.1], p < 0.001 for multiples), and more breastmilk feeding for at least six months (OR = 1.8 [1.3-2.3], p < 0.001 for singletons, OR = 3.6 [2.1-6.3], p < 0.001 for multiples). Readmissions also occurred less frequently with home care than with standard care, except for twins (OR = 0.7 [0.6-0.8], p < 0.001). CONCLUSION: Hospital-assisted neonatal home care for preterm infants was associated with better neurodevelopment at 2 years corrected age, shorter duration of hospitalization, and higher rates of breastmilk feeding at 6 months.

Equity in coronavirus disease 2019 vaccine development and deployment.

The coronavirus disease 2019 pandemic exposed weaknesses in multiple domains and widened gender-based inequalities across the world. It also stimulated extraordinary scientific achievement by bringing vaccines to the public in less than a year. In this article, we discuss the implications of current vaccination guidance for pregnant and lactating women, if their exclusion from the first wave of vaccine trials was justified, and if a change in the current vaccine development pathway is necessary. Pregnant and lactating women were not included in the initial severe acute respiratory syndrome coronavirus 2 vaccine trials. Therefore, perhaps unsurprisingly, the first vaccine regulatory approvals have been accompanied by inconsistent advice from public health, governmental, and professional authorities around the world. Denying vaccination to women who, although pregnant or breastfeeding, are fully capable of autonomous decision making is a throwback to a paternalistic era. Conversely, lack of evidence generated in a timely manner, upon which to make an informed decision, shifts responsibility from research sponsors and regulators and places the burden of decision making upon the woman and her healthcare advisor. The World Health Organization, the Task Force on Research Specific to Pregnant Women and Lactating Women, and others have highlighted the long-standing disadvantage experienced by women in relation to the development of vaccines and medicines. It is uncertain whether there was sufficient justification for excluding pregnant and lactating women from the initial severe acute respiratory syndrome coronavirus 2 vaccine trials. In future, we recommend that regulators mandate plans that describe the development pathway for new vaccines and medicines that address the needs of women who are pregnant or lactating. These should incorporate, at the outset, a careful consideration of the balance of the risks of exclusion from or inclusion in initial studies, patient and public perspectives, details of "developmental and reproductive toxicity" studies, and approaches to collect data systematically from participants who are unknowingly pregnant at the time of exposure. This requires careful consideration of any previous knowledge about the mode of action of the vaccine and the likelihood of toxicity or teratogenicity. We also support the view that the default position should be a "presumption of inclusion," with exclusion of women who are pregnant or lactating only if justified on specific, not generic, grounds. Finally, we recommend closer coordination across countries with the aim of issuing consistent public health advice.

Emotional responses of parents participating for the first time in caregiving for their baby in a neonatal unit.

BACKGROUND: Parents of term and preterm infants hospitalised at birth experience a stressful situation. They are considered as primary caregivers in neonatal units and are encouraged to participate in their child's care. OBJECTIVES: The aim of our study was to analyse the feelings of parents participating for the first time in caregiving for their baby admitted at birth in a neonatal unit in France and to compare the feelings reported by parents of term and preterm infants. METHODS: An online survey was created in 2014 for parents who had a baby hospitalised at birth. We analysed parents' responses to this open-ended question: "How did you feel when you participated in caregiving for your baby for the first time?" using a qualitative discourse analysis by two analysts. Themes were identified and coded. RESULTS: Between February 2014 and March 2018, 1603 parents of preterm infants and 239 parents of term infants responded to this open-ended question. Twenty-five per cent of parents expressed positive feelings exclusively (confidence, ease, joy, pride, feeling supported by healthcare professionals, by their family and feeling of being a parent), 41% expressed negative feelings exclusively (stress, fear, feeling of being judged, frustration, anger, uselessness and clumsiness) and 34% expressed mixed feelings (both positive and negative). Parents of term infants expressed less frequent feelings of stress and fear than parents of preterm infants: with a relative risk (RR) of 0.69, 95% confidence interval (CI) 0.56, 0.87. Parents of term babies more frequently expressed feelings of frustration: RR 2.40 (95% CI 1.33, 4.32). CONCLUSIONS: Infant- and Family-Centred Developmental Care supportive programmes are recommended within neonatal units in order to improve the experience of parents participating in caregiving for their baby hospitalised at birth.

Promoting attachment between parents and neonates despite the COVID-19 pandemic.

Social distancing is the only option available during the COVID-19 pandemic until a vaccine is developed. However, this is having a major impact on human relationships and bonding between parents and neonates is a major concern. Separation during this health emergency could have lifelong consequences for offspring, and there are even greater concerns if newborn infants are sick or vulnerable and need intensive care. We look at how bonding can be safely supported and maintained without risking infecting neonates, by comparing the international guidelines and proposing safe actions within those frameworks.