COHORT Study Unidade de Pesquisas Cl nicas Instituto de

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COHORT Study Unidade de Pesquisas Cl nicas Instituto de Powered By Docstoc

1. COMMUNITY CENSUS: A Census will be done of the community to investigate and survey the
     population where the research will be conducted.
        a. The census is taken by the Field Workers (FWs), under the supervision of the Study Nurse
           using the Census form. FWs follow a daily schedule and go house by house obtaining
           information on all members of each household until finishing the defined study area. The
           following information are hand-written on the Census form: household number, address,
           telephone #, date, the main source of drinking water for the members of the household, kind of
           toilet facility that the members of the household usually use, first and last name, relationship
           between the members of the house to the Household Head (RHH), date of birth, Sex,
           pregnancy status of women, date or the last menstrual period for the pregnant women, and
           weight and height for children 0-60 Months of age. The Brazil country code – BR, will be pre-
           printed on this form.
        b. Before the FWs measure the weight and height of the children aged 0 up to 60 months, they will
           obtain informed Census Consent from the parent or guardian of the children.
        c. The weight and height of these consented children are measured in the subject’s home.
        d. The census will be updated periodically throughout the study to identify future pregnant women.
2. ENROLLMENT: The pregnant women identified by the Census will be visited 4 times by the FWs
     in the following way:
       a) The first visit will occur around the 7th month of the pregnancy and the FWs will ask “what is the
          expected delivery date?”;
       b) The second visit will occur 30 days before the expected delivery date;
       c) The third visit will occur 10 days before the expected delivery date;
       d) The fourth visit will occur 5 days after the expected delivery date. If the mother has delivered her
          baby, the FWs will explain the study and obtain signed, informed Consent for enrolment, if not, the
          FWs will return five days later after the mother has delivered.
       e) The FWs will schedule with the mother the start date for the study (before the infant is17 days of
       f) On the first day of the study, the FW will follow the Study Surveillance Procedures.

3. ENROLMENT STRATEGY for Identifying Pregnant Women After Census:
       a) The FWs will ask the pregnant women (during visits starting at their 7th month of pregnancy and
          continuing throughout their participation in the study), if they know any other pregnant women in this
          community. The FWs will record this information and visit these women.
       b) The FWs will visit the ante-natal clinic and obtain information about any pregnant women that are
          living in the study community;
       c) The FWs will periodically update the Census as needed.

4. FREQUENCY of the recruitment:
     The expected average frequency of the recruitment will be an on-going process with
     recruitment of around 8-12 subjects per month. This process will continue until at least 235
     children have been enrolled.

5. SELECTION of the subject children:
     All children delivered in the study community meeting the inclusion and exclusion criteria will
     be eligible and asked to enroll in this study. Therefore, the first delivered child will be the first
     child to be recruited; the next subject to be recruited will be the second child that is delivered.
     This process will continue throughout the study with the expected enrollment of 8-12 per

                  Census data for urban communities in Fortaleza, Ceará, Brazil.

                                                       Parque     Papoco        Papoco
                  Parameters                        Universitário
                                                     (Nov/2006) (Feb/2009)     (Jul/2009)
                  Area (Km )                             2.5        2.3           7.5
                  Location from INCT-                    5 km      5 km           5 km
                  Biomedicine & UPC
                  Numbers household                      3,420     3,146         10,260

                  Population                            11,022     10,140        33,066
                  Number of birth per year                165       152           495

                  Anthropometry n (age < 3 yr)            340       60             228
                   HAZ % < -2                             7%       8,3%            9%
                   HAZ average                           -0.54     -0.54          -0.63
                    * Census date.
                      n = Sample size used for this calculation.

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