What's New
2024
July 2024: Bio Bank redesign amendment was submitted!
April 2024: GOOD Study 2.0 - Long-Term Gastrointestinal (GOOD-GI) & Long-Term Neurodevelopmental (GOOD-ND) are IRB approved!
February 2024: We are up to 13 sites enrolled in the Data Bank!
January 2024: We are up to 38 sites enrolled in the RCT!
January 2024: HAPPY NEW YEAR GOOD STUDY SITES!
2023
November/December 2023: Happy Holidays Everyone!
October 2023: Congratulations to Dr. A Jelin at the Johns Hopkins University for recieving the "In GOOD Hands" award!
September 2023: We are up to 7 sites enrolled in the data bank!
July 2023: We hit 70 patients enrolled in the trial, officially the largest Gastroschisis cohort.
July 2023: First batch of sites were added to the data bank!
June 2023: Congratulations to Rachel Tullar at Indiana University for receiving the "In GOOD Hands" Award.
June 2023: We would like to welcome Marcedes Campbell to the GOOD Study. Marcedes will be filling the role of Research Coordinator.
February 23, 2023: It is a bittersweet day for our GOOD study team as today is our program manager, Chris Fueger's last day. He has been an incredible manager and team member. We will miss him but are also extremely excited for him to take this next step in his career. So thank you Chris for all your time and hard work and good luck in your new position!
February 16, 2023: Congratulations to our program manager, Chris Fueger for recieving the "In GOOD Hands" award!
February 8, 2023: We are excited to announce packets for the Data Bank have been sent out to the first batch of sites. And we are looking forward to getting more sites up and running!
January 2023: HAPPY NEW YEAR GOOD STUDY SITES!
2022
November/December 2022: Happy Holidays Everyone!
October 2022: MCW's IRB has approved the amendment to add our seventh batch of sites! We look forward to training, onboarding and the enrollment of the following sites: Norton Healthcare and Indiana University/Riley Children's.
October 2022: Congratulations to Dr. J Newton at the Vanderbilt University Medical Center for recieving the "In GOOD Hands" award!
October 20, 2022: Thank you to everyone who came out to our meeting at NAFTNet! It was our first in-person meeting since COVID and was wonderful to see you all. We appreicated all the feedback and suggestions and hope you all enjoyed the pizza! Hope to see you all next year!
September 2022: Congratulations to Maha Al Jumaily at the University of South Florida for recieving the "In GOOD Hands" Award!
July 2022: Enrollment Recognition - Congratulations to the University of Utah for being the 4th site to enroll a new patient! A small gift will be there soon!
June 13, 2022: We would like to welcome Rachel Bailey to the GOOD Study! Rachel will be filling the role of Research Assistant previously vacated by Karina Montoto.
June 2022: Enrollment Recognition - Congratulations to University of South Florida, Loma Linda University, and UT Health for being the next three sites to enroll - a small gift is headed your way.
June 2022: Congratulations to Kim Ralston at Children's Hospital Colorado and Sara Caveglia at Rochester University for receiving the "In GOOD Hands" Award.
May 27, 2022: MCW's IRB has approved another amendment to add our sixth batch of sites! We are excited to start the onboarding process for the following sites: Rhode Island Hospital & Hasbro Children's Hospital, Cleveland Clinic, and Emory University
May 2022: Congratulations to Arica Stockett at the University of Maryland for receiving the "In GOOD Hands" Award!
April 19, 2022: Our Year 2 awards have officially been released!!
April 2022: Announcement! Next 4 sites to enroll a patient will recieve a small gift!
April 2022: Congratulations to Heather Cameron at the University of Michigan for receiving the "In GOOD Hands" Award!
March 2022: Rochester University Medical Center is the first site to fully execute the Data Bank and Bio Bank agreement!
February 22, 2022: Children's Hospital Colorado has enrolled our FIRST Spanish speaking participant!
February 11, 2022: We would like to thank Karina Montoto for all that she has done and as she departs from the GOOD Study we wish her all the best on her next chapter!
January 19, 2022: MCW's IRB has approved the addition of Dignity Health to the Phoenix Site!
January 18, 2022: All reliance agreements for the Data Bank and the Bio Bank have been sent out.
January 12, 2022: The 2021 Continuing Review has been approved! The new Expiration Date for the study is 01/11/2023
2021
December 9, 2021: MCW's IRB has approved another amendment to include spanish speaking participants and approved all translated documents
October 8, 2021: We would like to welcome Martin Bantchev as our new Database Manager for the GOOD Study! Martin will be taking over for Manzur Farazi who kindly stepped in as interim Database Manager for the GOOD Study. Thank you for all you have done Manzur!
September 8, 2021: Conducted our first all site GOOD Study conference call. Thank you to all of our sites who participated and we look forward to future calls!
September 7, 2021: We would like to welcome Karina Montoto to the GOOD Study. Karina will be filling the role of Research Assistant for the GOOD Study vacated by Jenna Dwyer. We wish Jenna the best of luck in her future endeavors!
August 16, 2021: We would like to welcome Madison Rundell to the GOOD Study. Maddie will be filling the role of Research Coordinator as Chris Fueger has now been promoted to Program Manager!
August 10, 2021: The Medical College of Wisconsin's IRB has approved another Amendement to add our fifth batch of participating sites. We are excited to begin the onboarding process with the University of Utah Health Sciences (PI: Dr. Fenton) !
June 30, 2021: The GOOD Study paid our first invoice to the University of Texas Health Science Center at Houston (PI: Dr. Austin). Thank you to all the participating staff for your hard work and collaboration!
April 20, 2021: MCW's IRB has approved another Amendment to add our fourth batch of participating sites. We are excited to begin the onboarding process for the following sites: Brigham and Women's Hospital & Boston Children's Hospital, Vanderbilt University Medical Center, Weill Cornell Medicine, OSF Healthcare Children's Hospital of Illinois, and Washington University in St. Louis.
*April 13, 2021: Today we are ecstatic to announce we have received notice that the Gastroschisis Outcomes of Delivery Study R01 $4.2m grant has been awarded by the NIH - NICHD! We cannot thank each and every team member and PI enough for your patience and support. You all have contributed greatly to this effort and we are so grateful to be able to move forward with this partnership and collaboration!*
February 2, 2021: The NIH - NICHD Advisory Counsel has completed a review of the GOOD Study R01 submission. We are eagerly awaiting the announcement of awards.
2020
November 5, 2020: The Medical College of Wisconsin's IRB has approved another GOOD Study extension project, the GOOD Study Bio Bank. We anticipate participating sites to enroll participants who are involved in the GOOD Study or Data Registry to this project. Our goal is to obtain blood samples from babies with gastroschisis to build a bank of biospecimens for future study. We are hopeful this project will help future investigators to provide additional insight into the contributing factors to this birth defect.
November 2, 2020: The NIH - NICHD Sceitntific Review Committee has completed a review of the GOOD Study R01 submission. The proposal received an impact score of 25, which falls within the 8th percentile. We are pleased with this score and anticipate additional review in the near future.
Summer 2020: COVID-19 has temporarily paused enrollment at some GOOD Study sites, including the lead site The Medical College of Wisconsin. DCC staff continues to work on onboarding participating sites and has begun data collection for the Data Registry. We hope everyone is staying safe and healthy, and we look forward to re-opening enrollment when we are able.
July 2, 2020: The Medical College of Wisconsin's IRB has approved an Amendment to add our third batch of participating sites. We look forward to training, onboarding and the enrollment of the following sites: Columbia University Irving Medical Center and University of Rochester & University of Rochester Medical Center. Thank you to all the staff and PIs at these participating sites - we look forward to this collaboration!
May 29, 2020: The GOOD Study team is thrilled to announce we have submitted a new R01 application to the NIH - NICHD for the GOOD Study and its extension proejcts. We are grateful for the opportunity and look forward to hearing feedback. Thank you to all the sites for your hard work in the preparation process!
January 23, 2020: Congratulations to our first participating site, University of North Carolina - Chapel Hill (PI: Dr. Goodnight), who officially began enrolling participants today!
2019
December 24, 2019: Today the Medical College of Wisconsin's IRB approved an Amendment to add our second batch of participating sites! We look forward to training, onboarding, and eventually announcing active enrollment at the following sites: Johns Hopkins University School of Medicine - Baltimore, University of Texas Health Science Center at Houston & Children's Memorial Hermann Hospital, Children's Mercy Hospital - Kansas City, Loma Linda University Health & Loma Linda Children's Hospital, Children's Minnesota & Allina Health - Minneapolis, and Phoenix Children's Hospital.
December 19, 2019: Despite very encouraging reviewer feedback, the March of Dimes has decided not to fund our application. We were very honored to receive an invitation to apply and appreciated all reviewer feedback. We know this process will only strenthen our application for future funding opportunities. We want to thank all the sites for generating application materials and for your commitment to the GOOD Study!
October 1, 2019: Today the Medical College of Wisconsin's IRB approved an Amendment to add our first batch of participating sites! We look forward to training, onboarding, and eventually announcing active enrollment at the following sites: University of Maryland - Baltimore, University of North Carolina - Chapel Hill, Medical City Dallas, University of Colorado - Denver, Leland Stanford Junior University, University of South Florida and University of Michigan - Ann Arbor.
August 30, 2019: The full grant application has been submitted to the March of Dimes! All 26 participating sites are included in the submission. We look forward to receiving notice of award in the coming months.
April 19, 2019: The GOOD Study is seeking an additional funding source from March of Dimes. We submitted a Letter of Intent and are awaiting an invite to apply for funding in July.
March 1, 2019: We would like to welcome our new Clinical Research Assistant, Jenna Dwyer! Jenna received her Bachelor of Arts in Psychology this past December from UW-Milwaukee. She has excellent clinical research experience, both working as an intern with the Wisconsin Ovarian Cancer Alliance and research assistant for the UW-Madison Center for Tobacco Research & Intervention. Jenna will be a valuable addition to our team as we move forward with the GOOD Study.
February 1, 2019: Unfortunately, the National Institutes of Health has decided not to found our R01 which was submitted back in October, 2018. We received extensive feedback which will help us improve our grant for future funding submissions. We want to thank the NIH and our participating sites who helped make this application possible, and we look forward to submitting again!
2018
October 12, 2018: Through a generous gift from the Melitta S. Pick and Joan M. Pick Charitable Trust to Children’s Hospital of Wisconsin, the GOOD Study has received funds to support its continuing work. This two year donation will provide resources needed to continue to move the GOOD Study forward. We are extremely grateful for this munificent support.
October 3, 2018: The grant titled "Gastroschisis Outcomes of Delivery (GOOD) Study" was submitted as an R01 application to the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at the NIH. We would like to thank everyone involved who helped make this application possible!
August 24, 2018: Through the efforts of 100's of individuals at 23 participating sites, 25 total subcontracts were submitted to our Data Coordinating Center in preparation for our NIH grant application. We thank everyone involved for their efforts and dedication to the GOOD Study!
May 23, 2018: The GOOD Provider Survey was published in Fetal Diagnosis and Therapy.
February 19, 2018: We would like to welcome Chris Fueger, MS to the GOOD Study. Chris will be filling the role of Research Coordinator for the GOOD Study vacated by Mary Emanuelson. We wish Mary success in her future endeavors!
2017
November 29, 2017: The GOOD Study Principal Investigators traveled to Bethesda, MD to meet with the NIH Program Officer assigned to the study. The meeting was extremely positive and the study team was encouraged to submit an R01 application for a clinical trial.
August 11, 2017: The GOOD Study has also received approval from the Medical College of Wisconsin's IRB to open a Data Registry. We look forward to enrolling patients who are not eligible for the RCT into this data registry as a way of collecting more information to better understand this birth defect and provide future researchers data for their studies.
August 9, 2017: The GOOD Study received approval from the Medical College of Wisconsin's IRB. Patient recruitment and enrollment into the GOOD Study has officially begun!
2016
December 10, 2016: We would like to express our profound gratitude to the Ladwig/Hamers Family for their donation made on behalf of Maddie.
August 16, 2016: We are pleased to announce that the Medical College of Wisconsin Department of Surgery has awarded the GOOD Study the We Care Fund for Medical Innovation and Research award. Receipt of this funding will enable us to give reimbursement stipends to participating sites during collection of pilot data.
May 12, 2016: The GOOD Study has been approved for a study record on ClinicalTrials.gov. This record is available to the public and will be periodically updated with information regarding study progress. Visit the study record on ClinicalTrials.gov.
March 7, 2016: We would like to thank The West Foundation for their generous donation to the GOOD Study! With their help, the team at our Data Coordinating Center will be better positioned with the resources it needs to generate pilot data for this important study. We plan to use this pilot data to prove feasibility of the GOOD Study, and apply for a larger grant from the National Institutes of Health. The West Foundation’s investment in babies with gastroschisis and the moms who carry them is amazing. We are extraordinarily grateful for their gift!