| Grant number: | 15/03256-1 |
| Support Opportunities: | Regular Research Grants |
| Start date: | June 01, 2015 |
| End date: | November 30, 2017 |
| Field of knowledge: | Health Sciences - Collective Health - Public Health |
| Principal Investigator: | Cristina Maria Garcia de Lima Parada |
| Grantee: | Cristina Maria Garcia de Lima Parada |
| Host Institution: | Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil |
| Associated researchers: | Maria Antonieta de Barros Leite Carvalhaes ; Vera Lucia Pamplona Tonete |
Abstract
This prospective cohort study aims to know data, events and situations related to the health of children living in Botucatu/SP in the first year of life. Will be developed within the research group "Women's, Children's and Adolescents' health" with participation of teachers and post graduate students of Botucatu Medical School. It consists of three sub-projects: 1 - Effects of elective caesarean section in the perinatal period and the first year of children´s life living in Botucatu/SP: cohort study; 2 -Breastfeeding and complementary feeding in children under one year in Botucatu/SP: cohort study and 3 -Health care of late preterm infants during the first year of life: cohort study. The cohort will be composed by Botucatu/SP residents, a medium-sized city of São Paulo, with a population of approximately 130.000 inhabitants. The catchment of mothers/children born in the two institutions (public and private one) of Botucatu will be performed in the first month after birth and the infant follow-up will be completed at the end of the first year of child's life. Five times are scheduled to face interview with the mother: in the first month of life, when the insertion in the cohort occurs and in the third, sixth, ninth and 12th month of life. For the subproject 2 are planned also two telephone interviews (in the second and in the fourth month of life). A sample of 540 children will be required to compose the cohort and, considering 1500 newly born per year in Botucatu, we intend to complete the entry until 10 months after baseline. The inclusion in the cohort, in most cases, will be performed in the Baby´s Clinic, a service that provides for all newborns of the city, care in the first days of life and has high coverage (over 90%). Children who missing of this service will be identified by Birth´s Live Declaration, archived on this service. Weekly, the two institutions will be visited and from maternal's records medical the contact numbers of the mothers will be obtained, so that these children can also be invited to participate of the cohort. All the procedures recommended to avoid losses to follow-up will be adopted. Data will be collected by paid and properly trained interviewers, supervised by a coordinator of field work. Instruments for data collection wereespecially constructed for this study, from the expertise of the authors.It contains information related to sociodemographic characteristics; about pregnancy, childbirth and neonatal period and relative to breastfeeding, nutrition, morbidity and growth in the first year of life, among others. These will be first tested and if necessary, the adjustments will be made, until get the final version to be used in research. The coding and data entry will be held concurrently to the collection, with support from field supervisor. Statistical analysis will be performed using SPSS v.15.0 software and willinclude descriptive presentation cohort data, univariate analysis of the variables of interest and being estimated the odds ratios values with 95% confidence interval from the Fisher's Exact Test or Chi-Square. When appropriate, will be used Cox regression models, logistic regression models univariate and multivariate, regression models with normal response, Gamma or other parametric model that adequately allows to model the numerical outcomes, considering the effects of potential confounders. In all analyzes, relations will be considered significant if p <0.05. Subprojects 1 and 2 were assessed by the Ethics Committee in Local Search, getting approval, respectively, under numbers 092149/2014 and 893508/2014. The subproject 3 will be assessed in March and data collection is initiated only after this approval. (AU)
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