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.
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!
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!
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!
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!
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!