Piccolipiù, a multicenter birth cohort in Italy: protocol of the study.

BACKGROUND: The fetal and infant life are periods of rapid development, characterized by high susceptibility to exposures. Birth cohorts provide unique opportunities to study early-life exposures in association with child development and health, as well as, with longer follow-up, the early life origin of adult diseases. Piccolipiù is an Italian birth cohort recently set up to investigate the effects of environmental exposures, parental conditions and social factors acting during pre-natal and early post-natal life on infant and child health and development. We describe here its main characteristics. METHODS/DESIGN: Piccolipiù is a prospective cohort of expected 3000 newborns, who will be recruiting in six maternity units of five Italian cities (Florence, Rome, Trieste, Turin and Viareggio) since October 2011. Mothers are contacted during pregnancy or at delivery and are offered to participate in the study. Upon acceptance, their newborns are recruited at birth and followed up until at least 18 years of age. At recruitment, the mothers donate a blood sample and complete a baseline questionnaire. Umbilical cord blood, pieces of umbilical cord and heel blood spots are also collected. Postnatal follow-up currently occurs at 6, 12, and 24 months of age using on-line or postal self administered questionnaire; further questionnaires and medical examinations are envisaged. Questionnaires collect information on several factors, including mother's and/or child's environmental exposures, anthropometric measures, reproductive factors, diet, supplements, medical history, cognitive development, mental health and socioeconomic factors. Health promotion materials are also offered to parents. DISCUSSION: Piccolipiù will broaden our understanding of the contribution of early-life factors to infant and child health and development. Several hypotheses on the developmental origins of health can be tested or piloted using the data collected from the Piccolipiù cohort. By pooling these data with those collected by other existing birth cohorts it will be possible to validate previous findings and to study rare exposures and outcomes.

The circulating levels of TRAIL are extremely low after delivery but rapidly recover in both mothers and newborns.

TNF-related apoptosis inducing ligand (TRAIL) plasma levels was measured in plasma samples obtained 1h (time 1) and 2-3 days (time 2) after delivery in a group of healthy women (n=17) who underwent cesarean delivery, and showed a significantly increase from time 1 (39.3 pg/ml median; 41.2 ± 15.9 mean ± SD) to time 2 (71.6 pg/ml median; 73.8 ± 27.8 mean ± SD). Similarly, circulating TRAIL levels were extremely low in the plasma of newborns (n=41) within the first 24h after partum (time 1; 27.5 pg/ml, median; 31.5 ± 15.8 means ± SD), showing a significant increase 2-3 days after partum (time 2; 68.4 pg/ml, median; 75.1 ± 36.7 mean ± SD). It is also noteworthy that the highest levels of plasma TRAIL were observed in newborns with the following characteristics: (i) born at later gestational age, (ii) Apgar score >9, (iii) higher birth weight, (iv) born through vaginal partum. In conclusion, we have demonstrated for the first time that the levels of circulating TRAIL are markedly low in both mothers and children after delivery, rapidly rising thereafter. Moreover, the highest levels of TRAIL are observed in newborns with the best clinical parameters.

Analysis of motivations that lead women to participate (or not) in a newborn cohort study.

BACKGROUND: Little is known about reasons that influence parents' decision to participate in studies enrolling healthy children. The aim of this observational study was to verify the reasons that lead pregnant women to give their consent or to refuse participation to a newborn cohort study with a long follow up time. METHODS: To prospectively investigate the reasons that lead women to participate, to refuse the participation or to withdraw from a newborn cohort study, three different questionnaires were administered to pregnant women contacted or enrolled in the Phime cohort study, carried out in an Italian Hospital from 2007 to 2010. RESULTS: Phime study participation was refused by 304 women and 145 withdrew their consent during the follow up. All these women filled in the related questionnaires. Within 632 mothers in follow up at 18 months, 430 filled in the questionnaire on motivation to participate: 97% stated that the main reason was to contribute to research; 96% and 90% stated that they wanted to benefit future babies' and mothers' health. Ninety-six percent of women would appreciate to know the results of analysis carried out on biological samples collected and of the overall study results. One third of the mothers (37%) wanted to be involved in the definition of future similar studies, bringing their experience and their views. Within the 304 women who refused participation, 56% stated that the study was too demanding, 26% was not interested in participating and 18% was concerned about the need to collect biological samples and to be submitted to neurocognitive tests. Fifty-two percent of 145 women who withdrew after enrollment stated that the study was too demanding (52%), and 6% was concerned about the biological samples collection. CONCLUSIONS: The altruistic reason appears to be the main reported by women to decide to participate in a newborn cohort study. The fact that the study was too demanding and the need to collect biological samples are important reasons that lead women to refuse participation or to withdraw from the study. An adequate communication on these aspects should minimize difficulties in enrolment and losses to follow up.