Noticias News Nouvelles

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1 Noticias News Nouvelles The Centre for Mother, Infant, and Child Research 7 th Floor, 790 Bay Street Toronto ON CANADA M5G 1N8 Tel: Fax: tbs@sw.ca website: V O L U M E 8, I S S U E 5 M A Y 3 1, Overall Total: 1911 Total this month: 41 INSIDE THIS ISSUE Emergency Help Line Reminder Second Interim Analysis 1 1 South American 2 Meeting Updates Query Tutorial 4 Emergency Help Line Reminder This is a reminder that the Emergency Help Line telephone number has changed to: (1) Alternatively, you may also contact a staff member at any time by sending an to: CMICRHELPLINE@sunnybrook.ca The Entry forms have been updated with the new instructions and will be sent to your centre with your regular top up. Staff Changes 5 1st Recruits 5 100th Recruits 5 Recruitment Excellence Recruitment Table 2yr Table Second Interim Analysis All babies for the first 1800 patients were born by the first week of May. Please send in all data forms, supporting documents and resolved queries to the Data Coordinating Centre as soon as possible. In the next few newsletters, we will publish the timeline for the database closure and also publish a report of centres with complete and clean data for the second interim analysis. Certificates will be given to centres that have reached 100% complete and clean data for the first 1800 patients.

2 PAGE 2 South American Regional Meeting Thank you to our collaborators from South America who were able to join us in Buenos Aires, Argentina in May for yet another successful meeting. We were very happy to see friends and make new ones. A special thanks to Dr Mario Palermo and Dr Dolores Montes Varela who were instrumental in helping us plan a great meeting. Below is a list of attendees who participated in the South American Collaborators Meeting: ARGENTINA Centro Rosarino de Estudios Perinatales Edgardo Abalos Hospital Alvarez Eugenia Arroche Maria Alejandra Bayugar Analia Messina Hospital Angela Iglesia de Llano Mabel Rivero Elena Gomez Hospital Avellaneda Viviana Rosario Dip Maria Mohedano de Duhalde Alicia Beatriz Roque Hospital de Clinicas de la Plata Osvaldo A. Yoma Recalde M Silvina Andrade Florencia Hospital DR. Ramón Madariaga Jorge Fernando Pianesi Hospital JM Cullen Carlos Arias Hospital JR Vidal Jesus Daniel Aguirre Hospital Juan A Fernandez Silvia Cristina Perez Macri Maria Jose Mattioli Jorge Orti Maria Jose Prieto Hector Sexer Rosa Waisman Hospital LC Lagomaggiore Raquel de Lourdes Martin Hospital Penna Marta Susana Bertin Jose Luis Castaldi Hospital Posadas Patricia Benitez Florencio Franze Maria Valeria Garcia Mario Palermo Lucio Ribola Dolores Montes Varela Monica Elizabeth Trasmonte Hospital Ramon Carrillo Miguel Curioni Hospital Sarda Cristina Laterra Ingrid Di Marco

3 PAGE 3 Participant List Continued: BRAZIL Botucatu Medical School Iracema de Mattos Calderon Claudia Garcia Magalhaes Jose Carlos Peracoli Hospital Materno Infantil Luiza Schmaltz Goianice Ribeiro de Souza Hospital Sao Lucas Caio Coelho Marques Pedro Luis Zanella Marie Jose Zenella Hospital Universitario Antonio Pedro Hospital Universitario de Jundiai Renato Augusto Moreira de Sa Nelson Lourenco Maia Filho Danielly Scaranello Nunes Santana Instituto de Medicina Integral Prof (IMIP) Alex Rolland Souza Adriana Scavuzzi Elias Melo Instituto de Saude Elpidio de Almeida (ISEA) Adriana Suely de Oliveira Melo Melania Amorim Carlos Noronha Neto ISCMPA-Maternidade Mario Totta Simone Moreira Mila Pontremoli Salcedo Hospital das Clinicas da UFPE Antonio Lima Ana Maria Porto Laranjeiras Clinica Perinatal Laudelino Lopes Maternidade Escola de UFRJ Nancy Ribeiro Da Silva Nelson Sass University of Campinas Jose Guillherme Cecatti Mary Angela Parpinelli Fernanda G Surita University of Pernambuco Olimpio Barbosa de Moraes Filho Simone Angelica Leite Silva CHILE Hospital Base Osorno Jorge Ricardo Carrillo Orellana Pedro Ferrand Hospital Dr Gustavo Fricke Luis Leighton Erika Madariaga Leiva Rodrigo Schiaffino Orrego Hospital Dr Sotero del Rio Ricardo Gomez Manuel Schepeler Karla Silva Neculman Universidad Catolica Cristian A. Gonzalez Enrique Oyarzun COLOMBIA Universidad Libre Rodrigo Cifuentes Dahiana Marcela Gallo Jose Maria Aramendiz ECUADOR Hospital Maternidad Enrique Sotomayor Gabriel Leon URUGUAY University of Uruguay Justo Alonso

4 PAGE 4 Query Tutorial A common query is to check that all parts of a question have been answered. Neonatal form question 2, asks if the baby had breathing difficulties after initial resuscitation. If the answer is YES, then the remaining questions (a-g) should have been answered. In the first example, all the questions were not answered. It is possible, the only causes were Respiratory Distress Syndrome and Pneumonia but you must indicate this by answering NO for the causes that do not apply (see example 2). Please answer ALL questions (a-g). Neonatal Form, Question 2 Please answer YES or NO for ALL questions. Please see example below.

5 TBS Staff Changes Congratulations on your first recruits Congratulations to the following teams on your first recruits: Dr Alain Gagnon and the team at Children's & Women's Health Centre of BC, Vancouver, Canada; Dr Dalia Schwake and the team at the Holy Family Hospital, Nazareth, Israel; and Dr M.M. Porath and the team at Maxima Medical Centre, Veldhoven, The Netherlands. Thank you for your hard work and congratulations on your first recruits! PAGE 5 We wish to update you on some staffing changes at CMICR: Trinh Hoac is leaving TBS and will be joining the CHIPS team (Control in Hypertension in Pregnancy Study) as the Research Coordinator. And, after her brief absence, Christine Tassopoulos has resumed her role in TBS as the Research Coordinator. You can reach Christine or Dalah at tbs@sw.ca. We thank Trinh for all the work she has done on TBS over the past months and we welcome Christine again to TBS! Congratulations on your 100th recruit! Congratulations to Dr Mario Palermo and the team at Hospital Posadas, Buenos Aires, Argentina. Thank you for your hard work and congratulations on your 100th recruit! Recruitment Excellence Congratulations to Dr Mario Palermo and the team at Hospital Posadas, Buenos Aires, Argentina; Dr Raul Abalos Gorostiaga and the team at Hospital Ramon Carrillo, Santiago del Estero, Argentina; Dr Renato Augusto Moreira de Sa and the team at Maternidade Escola da UFRJ, Rio de Janeiro, Brazil; Dr Danielly Scaranello Nunes Santana and the team at Hospital Universitario de Jundiai, Jundiai, Brazil; Dr Ricardo Gomez and the team at Hospital Dr Sotero del Rio, Puente Alto, Chile; Dr Marwan Hakim and the team at Nazareth Hospital (EMMS), Nazareth, Israel. Keep up the excellent work! We will be sending a gold seal to place on your Certificate of Achievement.

6 PAGE 6 Twin Birth Study Recruitment (Projected sample size of 2800) as of May 31, 2009 Jan - Jan - Jan - Jan - Jan - Jul - Jan - Annual Dec Dec Dec Dec Dec Jun Dec Feb Mar Apr May Grand Goal Total COUNTRY ARGENTINA BRAZIL CANADA POLAND ISRAEL CHILE EGYPT AUSTRALIA UK THE NETHERLANDS ESTONIA SERBIA USA JAMAICA SPAIN JORDAN HUNGARY ROMANIA GERMANY BELGIUM CROATIA GREECE Total CENTRES BY COUNTRY (Shaded area is prior to start-up) ARGENTINA Hospital LC Lagomaggiore, Mendoza Hospital Posadas, Buenos Aires Hospital Ramon Carrillo, Santiago del Estero Hospital Avellaneda, Tucuman Hospital JR Vidal, Corrientes Hospital Penna, Bahia Blanca Hospital Sarda, Buenos Aires Hospital Angela Iglesia de Llano, Corrientes Hospital Juan A Fernandez, Buenos Aires Hospital Alvarez, Buenos Aires Centres that are no longer recruiting 0 10 BRAZIL University of Campinas, Campinas Maternidade Escola da UFRJ, Rio de Janeiro University of Pernambuco, Recife Hospital Universitario Antonio Pedro, Niteroi Laranjeiras Clinica Perinatal, Rio de Janeiro ISCMPA-Maternidade Mario Totta, Porto Alegre Hospital Universitario de Jundiai, Jundiai Hospital Sao Lucas, Porto Alegre UFPE, Recife Botucatu Medical School, Botucatu Hospital Materno Infantil, Goiania CANADA Sunnybrook Health Sciences Centre, Toronto McMaster University Medical Centre, Hamilton IWK Health Centre, Halifax Regina General Hospital, Regina Trillium Health Centre, Mississauga Lions Gate Hospital, Vancouver Mount Sinai Hospital, Toronto Foothills Medical Centre, Calgary SMBD Jewish General Hospital, Montreal Royal Columbian Hospital, New Westminster Royal University Hospital, Saskatoon Eastern Health, St John's North Bay General Hospital, North Bay St Joseph's Health Care, London Toronto East General, Toronto Children's & Women's Health Centre of BC, Vancouver Centres that are no longer recruiting 0 1 POLAND University School of Medical Sciences, Poznan Polish Mothers Memorial Hospital, Lodz Medical University of Gdansk, Gdansk

7 PAGE 7 Jan - Jan - Jan - Jan - Jan - Jul - Jan - Annual Dec Dec Dec Dec Dec Jun Dec Feb Mar Apr May Grand Goal Total ISRAEL Edith Wolfson Medical Center, Holon Ma'ayney HaYeshua Medical Center, Bnei Brak Nazareth Hospital (EMMS), Nazareth HaEmek Medical Center, Afula Poriya Government Hospital, Tiberias Bnai Zion Medical Center, Haifa Hillel Yaffe Medical Center, Hadera Holy Family Hospital, Nazareth CHILE Hospital Dr Gustavo Fricke, Vina del Mar Hospital Dr Sotero del Rio, Puente Alto EGYPT Assiut University Hospital, Assiut AUSTRALIA Ipswich Hospital, Ipswich Mater Mothers' Hospital, Brisbane St George Hospital, Sydney Toowoomba Base Hospital, Toowoomba Monash Medical Centre, Clayton Logan Hospital, Meadowbrook Townsville Hospital, Townsville Women's and Children's Hospital, Adelaide UK Bradford Royal Infirmary, Bradford Nottingham City Hospital, Nottingham Basildon & Thurrock University, Basildon Queen Elizabeth Hospital, King's Lynn University Hospital of North Staffordshire, Stoke-on-Trent Derriford Hospital, Plymouth Queens Medical Centre, Nottingham Lewisham Hospital, London THE NETHERLANDS Atrium Medical Center, Heerlen Academisch Ziekenhuis Maastricht, Maastricht Sint Lucas Andreas Ziekenhuis, Amsterdam Maxima Medical Centre, Veldhoven Centres that are no longer recruiting 0 7 ESTONIA Tartu University Hospital - Women's Clinic, Tartu SERBIA University of Belgrade, Belgrade JAMAICA University Hospital of the West Indies, Kingston USA East Bay Perinatal Medical Associates, Oakland Maricopa Medical Center, Phoenix University of South Carolina, Columbia University of Iowa Hospitals and Clinics, Iowa City University of Miami, Miami Centres that are no longer recruiting 0 4 SPAIN Hospital Clinic-University of Barcelona, Barcelona JORDAN Islamic Hospital, Amman HUNGARY University of Debrecen, Debrecen ROMANIA University of Pharmacy and Medicine, Cluj-Napoca GERMANY Ludwig Maximilians University of Munich, Munich CUB - Virchow Klinikum, Berlin CUB - Benjamin Franklin, Berlin BELGIUM Vrije Universiteit Brussel, Brussels CROATIA Sveti Duh Hospital, Zagreb GREECE Alexandra Maternity, Athens Centres awaiting first patient: [COUNTRY: Hospital, City (annual goal)] [month/year start-up package sent] AUSTRALIA: Royal North Shore, St Leonards (3) [11/06]; CANADA: St Paul s Hospital, Vancouver (3) [01/09]; UK: Aberdeen Maternity, Aberdeen (6) [11/06], Liverpool Women's Hospital, Liverpool (12) [05/07]; USA: Washington University, St Louis (5) [01/07];

8 PAGE 8 2 Year Follow-up of TBS Babies The status of the TBS 2 Year Follow-up is displayed in the following table for centres that recruited patients. Centres are listed according to the total number of recruits by country and centre. See below for the number of follow-up assessments performed by your centre! Let's aim for 100% follow-up!! Status Totals As of May 2009 COUNTRY ARGENTINA BRAZIL CANADA POLAND ISRAEL CHILE EGYPT AUSTRALIA UK THE NETHERLANDS ESTONIA SERBIA JAMAICA USA JORDAN SPAIN HUNGARY ROMANIA GERMANY BELGIUM CROATIA GREECE Total % 89.0% 82.3% 75.3% 17.1% 41% CENTRES BY COUNTRY (Shaded area is prior to start-up) ARGENTINA Hospital LC Lagomaggiore, Mendoza Hospital Posadas, Buenos Aires Hospital Ramon Carrillo, Santiago del Estero Hospital Avellaneda, Tucuman Hospital JR Vidal, Corrientes Hospital Penna, Bahia Blanca Hospital Sarda, Buenos Aires Hospital Angela Iglesia de Llano, Corrientes Hospital Juan A Fernandez, Buenos Aires Hospital Ramos Mejia, Buenos Aires Hospital Alvarez, Buenos Aires BRAZIL University of Campinas, Campinas Maternidade Escola da UFRJ, Rio de Janeiro University of Pernambuco, Recife Hospital Universitario Antonio Pedro, Niteroi Laranjeiras Clinica Perinatal, Rio de Janeiro ISCMPA-Maternidade Mario Totta, Porto Alegre Hospital Universitario de Jundiai, Jundiai Hospital Sao Lucas, Porto Alegre UFPE, Recife Botucatu Medical School, Botucatu Hospital Materno Infantil, Goiania CANADA Sunnybrook Health Sciences Centre, Toronto McMaster University Medical Centre, Hamilton IWK Health Centre, Halifax Regina General Hospital, Regina Trillium Health Centre, Mississauga Lions Gate Hospital, Vancouver Mount Sinai Hospital, Toronto Foothills Medical Centre, Calgary SMBD Jewish General Hospital, Montreal Royal Columbian Hospital, New Westminster Royal University Hospital, Saskatoon North Bay General Hospital, North Bay 3 3 St Joseph's Health Care, London Eastern Health, St John's Toronto East General, Toronto York Central Hospital, Richmond Hill 1 1 Children's & Women's Health Centre of BC, Vancouver 1 1 POLAND Univ School of Medicine, Poznan Polish Mothers Memorial Hospital, Lodz Medical University of Gdansk, Gdansk

9 PAGE 9 Status Totals As of May 2009 ISRAEL Edith Wolfson Medical Center, Holon Ma'ayney HaYeshua Medical Center, Bnei Brak Nazareth Hospital (EMMS), Nazareth Poriya Government Hospital, Tiberias HaEmek Medical Center, Afula Bnai Zion Medical Center, Haifa Hillel Yaffe Medical Center, Hadera Holy Family Hospital, Nazareth 1 1 CHILE Hospital Dr Gustavo Fricke, Vina del Mar Hospital Dr Sotero del Rio, Puente Alto EGYPT Assiut University Hospital, Assiut AUSTRALIA Ipswich Hospital, Ipswich Mater Mothers' Hospital, Brisbane St George Hospital, Sydney Toowoomba Base Hospital, Toowoomba Monash Medical Centre, Clayton Logan Hospital, Meadowbrook Townsville Hospital, Townsville Women's and Children's Hospital, Adelaide 1 1 UK Bradford Royal Infirmary, Bradford Nottingham City Hospital, Nottingham Basildon & Thurrock University, Basildon Queen Elizabeth Hospital, King's Lynn University Hospital of North Staffordshire, Stoke-on-Trent Derriford Hospital, Plymouth Queens Medical Centre, Nottingham 3 3 Lewisham Hospital, London 3 3 THE NETHERLANDS Atrium Medical Center, Heerlen Maaslandziekenhuis Sittard, Sittard Academisch Ziekenhuis Maastricht, Maastricht Sint Lucas Andreas Ziekenhuis, Amsterdam Maxima Medical Centre, Veldhoven 1 1 ESTONIA Tartu University Hospital - Women's Clinic, Tartu SERBIA University of Belgrade, Belgrade JAMAICA University Hospital of the West Indies, Kingston USA East Bay Perinatal Medical Associates, Oakland Maricopa Medical Center, Phoenix University of South Carolina, Columbia University of Iowa Hospitals and Clinics, Iowa City Jamaica Hospital Medical Center, Jamaica Texas Tech UHSC, Lubbock 2 2 University of Miami, Miami 1 1 JORDAN Islamic Hospital, Amman SPAIN Hospital Clinic-University of Barcelona, Barcelona HUNGARY University of Debrecen, Debrecen ROMANIA University of Pharmacy and Medicine, Cluj-Napoca GERMANY Ludwig Maximilians University of Munich, Munich CUB - Virchow Klinikum, Berlin 3 3 CUB - Benjamin Franklin, Berlin BELGIUM Vrije Universiteit Brussel, Brussels CROATIA Sveti Duh Hospital, Zagreb GREECE Alexandra Maternity, Athens 1 3 4