Danish National Birth Cohort (DNBC)

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Frederikke Gregersen
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1 Danish National Birth Cohort (DNBC) Application form for access to data and biological samples ref Project title: Applicant: Betydning af feber under graviditeten for barnets motoriske udvikling Name: Charlotte Amby Holst Address: Statens Serum Institut, Afdeling for Epidemiologisk Forskning, Ørestads Boulevard 5, 2300 København S Other partners taking part in the project Names and work addresses: Name: Sanne Ellegaard Jørgensen Address: Statens Serum Institut, Afdeling for Epidemiologisk Forskning, Ørestads Boulevard 5, 2300 København S Mads Melbye Statens Serum Institut, Afdeling for Epidemiologisk Forskning, Ørestads Boulevard 5, 2300 København S Anne-Marie Nybo Andersen Institut for Folkesundhedsvidenskab, Øster Farimagsgade 5, postboks 2099, 1014 København K Project description (max 200 words) The description should contain 1) purpose, 2) method, material, data, 3) time schedule, 4) publishing and 5) up to 5 key words Formålet med kandidatspecialet er at undersøge sammenhænge mellem maternel feber under graviditeten og barnets motoriske udvikling. Ydermere er formålet at kvantificere eventuelle sammenhænge. Information vedr. eksponeringen (maternel feber) hentes fra 1. og 2. graviditetsinterview, mens information om udfaldene (barnets motoriske udvikling) hentes fra 3. og 4. interview, samt 7års-undersøgelsen. Vi vil desuden benytte information fra de fire interviews samt 7års-undersøgelsen i forbindelse med identificerede kovariater, herunder eksempelvis maternel alder, rygestatus og prænatalt alkoholindtag. Vi vil indledningsvist udarbejde deskriptiv statistik over det relevante datamateriale, for dernæst at lave mere avancerede analyser, herunder overlevelsesanalyser. For tidsplan, se bilag. Projektet udmøntes i et kandidatspeciale ved Institut for Folkesundhedsvidenskab, Københavns Universitet. Derefter vil vi, på baggrund af det færdige speciale, skrive en videnskabelig artikel, som vil blive forsøgt publiceret. Journals er pt. ikke udvalgt. Key words: feber, motorik, graviditet, centralnervesystem, Developmental coordination disorder 1

2 Time schedule: Projec start: Data analyses terminated : Final project report: Month august Year 2011 Month april Year 2012 Month april Year 2012 Please indicate articles planned and their approx title(s): Based on the data applied for, I plan to publish Article 1, titel: Fever in pregnancy and risk of delayed motor development in infancy and childhood: a population-based study Article 2, titel: Article 3, title: Project protocol enclosed: yes Interview Data Are you applying for interview data? yes Int 1 Int 2 Int 3 Int 4 7-year follow-up Selection criteria: Specification of data required: (list of variables to be agreed with the DNBC data manager) I specialet vil studiepopulationen omfatte kvinder, der i perioden blev rekrutteret til kohorten Bedre sundhed for mor og barn og som har besvaret enten ja eller nej til spørgsmålet Har du haft feber, mens du har været gravid? i 1. (variabel A100) eller andet 2. interview (variabel B110). Yderligere inklusionskriterier er, at kvinderne har besvaret samtlige spørgsmål om barnets motoriske udvikling fra minimum et interview eller spørgeskema efter fødslen samt at der er tale om enkeltfødsler(singletons). Kvinder som har deltaget mere end én gang i kohorten ekskluderes desuden. Ydereligere ekskluderes respondenten, hvis de har svaret ved ikke til et eller flere af de motoriske spørgsmål. Se bilag No. of individuals concerned: Dette vides ikke endnu. 2

3 Biological Specimens Are you applying for biological specimens? yes: Only a minimum quantity of blood necessary for the analyses in question will be handed out. Please te that DNA is t yet available from all participants. DNA must be extracted at Statens Serum Institut. from 1st sample quantity from 2nd sample quantity from 3rd sample quantity Please describe how your study design is adapted to make the best possible use of the biological specimens. Account for the feasibility of the analyses (requirements for transportation, treatment and storages must be taken into consideration). Number of persons, selection criteria, time period: For what kind of analyses? (state purpose and method): Where are the laboratory analyses carried out?: References from the laboratory may be enclosed. Supplementary Data Collection Sample analyses results Will you be collecting supplementary data/biological samples from cohort members, or will new analyses data be generated? In you application to the Danish Data Protection Agency (DDPA) remember to state that you will return supplementary data to the DNBC No Yes Supplementary data and results from biological analyses, including geme-wide scans must after approval from the DDPA - be returned to the DNBC database and be made available for other scientists. If you are contacting DNBC participants by mail, this contact must be initiated by the DNBC secretariat. Which kind of data/biological samples? interview/questionnaire (to be enclosed) linkage with other registries (please specify) biological specimens (please specify) How many individuals will be concerned? During which time period will collection take place? 3

4 Other Approvals Is your project/data collection approved by: Danish Biomedical Research Ethics Committee yes (copy of approval to be enclosed) The Danish Data Protection Agency yes (copy of approval to be enclosed) Finances The invoice for the data file should be sent to: Name: Address: Is the project fully financed? No Yes, amount: Name of the funding person/organisations: 4

5 Date and signature Date and signature: Save the application form to your harddisk and mail to together with your protocol and other relevant documentation. 5

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