- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05685745
Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset
Study Overview
Status
Detailed Description
The minimum dataset collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The data collected include information on:
- Demographics of mother and infant
- Mother's health, labor and delivery
- Infant's health, medical interventions, and clinical outcomes
These data are used to: provide participating hospitals with reporting for use in quality improvement; evaluate associations between baseline characteristics, treatments, and outcomes; and track trends in disease and therapy.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Matthew A Rysavy, MD, PhD
- Phone Number: 713-500-5651
- Email: Matthew.A.Rysavy@uth.tmc.edu
Study Locations
-
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Queensland
-
South Brisbane, Queensland, Australia, 4101
- Recruiting
- Mater Mother's Hospital
-
Contact:
- Luke Jardine, MD
- Email: Luke.Jardine@mater.org.au
-
Principal Investigator:
- Luke Jardine, MD
-
Principal Investigator:
- Adam Bush, MD
-
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Victoria
-
Heidelberg, Victoria, Australia, 3084
- Not yet recruiting
- Mercy Hospital for Women
-
Contact:
- Tammy Brinsmead, MD
- Email: BrinsT@mercy.com.au
-
Principal Investigator:
- Tammy Brinsmead, MD
-
Principal Investigator:
- Alex Shub, MD
-
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Western Australia
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Perth, Western Australia, Australia, 6008
- Recruiting
- King Edward Memorial Hospital
-
Contact:
- Emma Harris, MD
- Email: Emma.Harris@health.wa.gov.au
-
Principal Investigator:
- Emma Harris, MD
-
Principal Investigator:
- Scott White, MD
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British Columbia
-
Surrey, British Columbia, Canada, V3V 1Z2
- Not yet recruiting
- Fraser Health Surrey Memorial Hospital
-
Principal Investigator:
- Jason Burrows, MD
-
Contact:
- Rebecca Sherlock, MD
- Email: rebecca.sherlock@fraserhealth.ca
-
Principal Investigator:
- Rebecca Sherlock, MD
-
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Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Sunnybrook Health Sciences Centre
-
Contact:
- Maya Dahan, MD
- Email: maya.dahan@sunnybrook.ca
-
Principal Investigator:
- Maya Dahan, MD
-
Principal Investigator:
- Marie Buitendyk, MD
-
-
-
-
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Cologne, Germany
- Recruiting
- University of Cologne
-
Contact:
- Katrin Mehler, MD
- Email: Katrin.mehler@uk-koeln.de
-
Principal Investigator:
- Katrin Mehler, MD
-
Principal Investigator:
- Berthold Gruettner, MD
-
-
-
-
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Tokyo, Japan
- Not yet recruiting
- National Center for Child Health and Development
-
Contact:
- Tetsuya Isayama, MD
- Email: isayama77@gmail.com
-
Principal Investigator:
- Tetsuya Isayama, MD
-
Principal Investigator:
- Seiji Wada, MD
-
-
Mitaka
-
Shinkawa, Mitaka, Japan
- Recruiting
- Kyorin University Hospital
-
Contact:
- Kenichiro Hosoi, MD
- Email: hosoi-k@ks.kyorin-u.ac.jp
-
Principal Investigator:
- Kenichiro Hosoi, MD
-
Principal Investigator:
- Shinji Tanigaki, MD
-
-
Nagano
-
Azumino, Nagano, Japan
- Recruiting
- Nagano Children's Hospital
-
Contact:
- Toshimitsu Yanagisawa, MD
- Email: toshimitsu-yanagisawa@nkodomo-hsp.jp
-
Principal Investigator:
- Toshimitsu Yanagisawa, MD
-
Principal Investigator:
- Shiro Yoshida, MD
-
-
Osaka
-
Izumi, Osaka, Japan
- Recruiting
- Osaka Women's & Children's Hospital
-
Contact:
- Shinya Hirano, MD
- Email: shirano@wch.opho.jp
-
Principal Investigator:
- Kazuko Wada, MD
-
Principal Investigator:
- Keisuke Ishii, MD
-
-
Saitama
-
Kawagoe, Saitama, Japan
- Recruiting
- Saitama Medical Center, Saitama Medical University
-
Contact:
- Fumihiko Namba, MD, PhD
- Phone Number: +81-49-228-3727
- Email: nambaf@saitama-med.ac.jp
-
Principal Investigator:
- Fumihiko Namba, MD, PhD
-
Principal Investigator:
- Shinichiro Yabe, MD
-
-
Tochigi
-
Shimotsuke, Tochigi, Japan
- Recruiting
- Jichi Medical University Hospital
-
Contact:
- Yumi Kono, MD
- Email: ykono@jichi.ac.jp
-
Principal Investigator:
- Yumi Kono, MD
-
Principal Investigator:
- Hironori Takahashi, MD
-
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-
-
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La Paz, Spain
- Recruiting
- La Paz Hospital
-
Contact:
- Gonzalo Solis-Garcia, MD
- Email: gonzalo.solis@salud.madrid.org
-
Principal Investigator:
- Gonzalo Solis-Garcia, MD
-
Principal Investigator:
- Jose Luis Bartha, MD
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Uppsala, Sweden
- Recruiting
- Uppsala University Hospital
-
Contact:
- Johan Agren, MD, PhD
- Email: johan.agren@kbh.uu.se
-
Principal Investigator:
- Johan Agren, MD, PhD
-
Principal Investigator:
- Maria Jonsson, MD
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-
-
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Alabama
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Birmingham, Alabama, United States, 35249
- Recruiting
- University of Alabama at Birmingham
-
Contact:
- Colm Travers, MD
- Phone Number: 205-934-4680
- Email: cptravers@uabmc.edu
-
Principal Investigator:
- Colm Travers, MD
-
Principal Investigator:
- Ashley Battarbee, MD
-
Mobile, Alabama, United States, 36688
- Recruiting
- University of South Alabama
-
Contact:
- Kalsang Dolma, MD
- Email: kdolma@health.southalabama.edu
-
Principal Investigator:
- Kalsang Dolma, MD
-
Principal Investigator:
- Amy Hewes, MD
-
-
Arizona
-
Phoenix, Arizona, United States, 85008
- Recruiting
- Vallywise Health Medical Center
-
Contact:
- Jason Couch, MD
- Email: jason_couch@dmgaz.org
-
Principal Investigator:
- Jason Couch, MD
-
Principal Investigator:
- Dean Coonrod, MD
-
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California
-
Long Beach, California, United States, 90806
- Recruiting
- Miller Children's & Women's Hospital
-
Contact:
- Anupama Shetty, MD
- Email: ashetty@memorialcare.org
-
Principal Investigator:
- Anupama Shetty, MD
-
Principal Investigator:
- Megan Oakes, MD
-
Orange, California, United States, 92868
- Recruiting
- Children's Hospital, Orange County
-
Contact:
- Michel Mikhael, MD
- Email: MMikhael@choc.org
-
Principal Investigator:
- Michel Mikhael, MD
-
San Diego, California, United States, 92093
- Recruiting
- University of California, San Diego
-
Contact:
- Katherine Weiss, MD
- Email: kaweiss@health.ucsd.edu
-
Principal Investigator:
- Katherine Weiss, MD
-
Principal Investigator:
- Thomas Kelly, MD
-
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Florida
-
Hollywood, Florida, United States, 33021
- Recruiting
- Joe DiMaggio Children's Hospital
-
Contact:
- Doron Kahn, MD
- Email: DKahn@mhs.net
-
Principal Investigator:
- Doron Kahn, MD
-
Principal Investigator:
- Elvire Jacques, MD
-
Jacksonville, Florida, United States, 32207
- Recruiting
- Wolfson Children's Hospital
-
Principal Investigator:
- Josef Cortez, MD
-
Contact:
- Josef Cortez, MD
- Email: josef.cortez@jax.ufl.edu
-
Principal Investigator:
- Erin Burnett, MD
-
Jacksonville, Florida, United States, 32209
- Recruiting
- University of Florida, Jacksonville
-
Principal Investigator:
- Josef Cortez, MD
-
Contact:
- Josef Cortez, MD
- Email: josef.cortez@jax.ufl.edu
-
Principal Investigator:
- Erin Burnett, MD
-
Orlando, Florida, United States, 32806
- Recruiting
- Orlando Health Winnie Palmer Hospital for Women & Babies
-
Principal Investigator:
- Neeraj Desai, MD
-
Contact:
- Thais O Queliz Pena, MD
- Email: Thais.QuelizPena@orlandohealth.com
-
Principal Investigator:
- Thais Queliz Pena, MD
-
St. Petersburg, Florida, United States, 33701
- Recruiting
- Johns Hopkins All Children's Hospital
-
Contact:
- Mara DiBartolomeo, MD
- Email: mdibart2@jhmi.edu
-
Principal Investigator:
- Mara DiBartolomeo, MD
-
Principal Investigator:
- Brad Sipe, MD
-
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Georgia
-
Atlanta, Georgia, United States, 30308
- Recruiting
- Emory University Hospital Midtown
-
Principal Investigator:
- Ravi Patel, MD
-
Contact:
- Ravi Patel, MD
- Email: rmpatel@emory.edu
-
Principal Investigator:
- Iris Krishna, MD
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Emory University Grady Memorial
-
Principal Investigator:
- Ravi Patel, MD
-
Contact:
- Ravi Patel, MD
- Email: rmpatel@emory.edu
-
Principal Investigator:
- Iris Krishna, MD
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- Recruiting
- University of Iowa
-
Contact:
- Tarah Colaizy, MD
- Phone Number: 319-356-3508
- Email: tarah-colaizy@uiowa.edu
-
Principal Investigator:
- Tarah Colaizy, MD
-
Principal Investigator:
- Mark Santillan, MD
-
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Kentucky
-
Lexington, Kentucky, United States, 40536
- Recruiting
- University Of Kentucky
-
Principal Investigator:
- John O'Brien, MD
-
Contact:
- Prasad Bhandary, MD
- Email: prasad.bhandary@uky.edu
-
Principal Investigator:
- Prasad Bhandary, MD
-
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Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Laura Bernardini, MD
- Email: lbernardini@bwh.harvard.edu
-
Principal Investigator:
- Laura Bernardini, MD
-
Principal Investigator:
- Thomas McElrath, MD
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Beth Israel Deaconess Medical Center
-
Principal Investigator:
- Helen Healy, MD
-
Contact:
- Helen Healy, MD
- Email: hhealy@bidmc.harvard.edu
-
Principal Investigator:
- Cassandra Duffy, MD
-
Boston, Massachusetts, United States, 02120
- Recruiting
- Brigham and Women's Hospital
-
Contact:
- Laura Bernardini, MD
- Email: lbernardini@bwh.harvard.edu
-
Principal Investigator:
- Laura Bernardini, MD
-
Principal Investigator:
- Thomas McElrath, MD
-
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Nebraska
-
Omaha, Nebraska, United States, 68114
- Recruiting
- Nebraska Medicine
-
Contact:
- Ann Anderson-Berry, MD, PhD
- Email: alanders@unmc.edu
-
Principal Investigator:
- Ann Anderson-Berry, MD, PhD
-
Principal Investigator:
- Rebecca Rimsza, MD
-
-
New York
-
The Bronx, New York, United States, 10467
- Recruiting
- The Children's Hospital at Montefiore
-
Contact:
- Shantanu Rastogi, MD
- Email: shrastogi@montefiore.org
-
Principal Investigator:
- Shantanu Rastogi, MD
-
Principal Investigator:
- Rodney Wright, MD
-
-
North Carolina
-
Durham, North Carolina, United States, 27708
- Recruiting
- Duke University
-
Principal Investigator:
- Brenna Hughes, MD
-
Contact:
- Noelle Younge, MD
- Email: noelle.younge@duke.edu
-
Principal Investigator:
- Noelle Younge, MD
-
Greenville, North Carolina, United States, 27858
- Recruiting
- East Carolina University
-
Contact:
- Weili Chang, MD
- Email: changw@ecu.edu
-
Principal Investigator:
- Weili Chang, MD
-
Principal Investigator:
- James deVente, MD
-
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Ohio
-
Cincinnati, Ohio, United States, 45229
- Not yet recruiting
- Cincinnati Children's Hospital Medical Center
-
Contact:
- Faris Al Garaibeh, MD
- Email: faris.algharaibeh@cchmc.org
-
Principal Investigator:
- Faris Al Garaibeh, MD
-
Principal Investigator:
- Robert Rossi, MD
-
Columbus, Ohio, United States, 43205
- Recruiting
- Nationwide Children's Hospital
-
Contact:
- Carl H Backes Jr., MD
- Phone Number: 614-722-3824
- Email: carl.backes@nationwidechildrens.org
-
Principal Investigator:
- Carl H Backes Jr., MD
-
Principal Investigator:
- Kara Rood, MD
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health and Science University
-
Contact:
- Brian Scottoline, MD
- Email: scottoli@ohsu.edu
-
Principal Investigator:
- Brian Scottoline, MD
-
Principal Investigator:
- Andrew Chon, MD
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Pennsylvania Hospital
-
Contact:
- Dustin Flannery, DO, MSCE
- Email: flanneryd@chop.edu
-
Principal Investigator:
- Dustin Flannery, DO, MSCE
-
Principal Investigator:
- Haresh Sehdev, MD
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Hospital of the University of Pennsylvania
-
Contact:
- Dustin Flannery, DO, MSCE
- Email: flanneryd@chop.edu
-
Principal Investigator:
- Dustin Flannery, DO, MSCE
-
Principal Investigator:
- Harish Sehdev, MD
-
-
Texas
-
Fort Worth, Texas, United States, 76104
- Recruiting
- Texas Health Resources Harris Hospital
-
Contact:
- Russell Lawrence, MD
- Email: russell.lawrence@pediatrix.com
-
Principal Investigator:
- Russell Lawrence, MD
-
Houston, Texas, United States, 77030
- Recruiting
- The University of Texas Health Science Center at Houston
-
Principal Investigator:
- Hector Mendez-Figueroa, MD
-
Contact:
- Catherine C Beaullieu, MD
- Phone Number: 713-500-5733
- Email: Catherine.C.Beaullieu@uth.tmc.edu
-
Principal Investigator:
- Catherine C Beaullieu, MD
-
Houston, Texas, United States, 77030
- Recruiting
- Texas Children's Hospital
-
Contact:
- Shweta Parmekar, MD
- Email: ssparmek@texaschildrens.org
-
Principal Investigator:
- Shweta Parmekar, MD
-
Principal Investigator:
- Manisha Gandhi, MD
-
Houston, Texas, United States, 77054
- Recruiting
- The Women's Hospital of Texas
-
Contact:
- Kaashif Ahmad, MD
- Email: kahmad@uh.edu
-
Principal Investigator:
- Kaashif Ahmad, MD
-
Principal Investigator:
- Anushka Chellia, MD
-
San Antonio, Texas, United States, 78229
- Recruiting
- St. Luke's Baptist Hospital
-
Contact:
- Christine Aune, MD
- Email: christine.aune@pediatrix.com
-
Principal Investigator:
- Christine Aune, MD
-
Principal Investigator:
- Randall Davis, MD
-
San Antonio, Texas, United States, 78258
- Recruiting
- North Central Baptist Hospital
-
Contact:
- Mary Wearden, MD
- Email: mary.wearden@pediatrix.com
-
Principal Investigator:
- Mary Wearden, MD
-
Principal Investigator:
- Erin Mankus, MD
-
San Antonio, Texas, United States, 78229
- Recruiting
- Methodist Children's Hospital
-
Contact:
- Katherine Johnson, MD
- Email: katherine.m.johnson@pediatrix.com
-
Principal Investigator:
- Katherine Johnson, MD
-
Principal Investigator:
- Elizabeth De La Garza, MD
-
San Antonio, Texas, United States, 78207
- Recruiting
- CHRISTUS Children's Hospital
-
Principal Investigator:
- James Hill, MD
-
Contact:
- Pratik Parikh, MD
- Email: pratik.parikh@pediatrix.com
-
Principal Investigator:
- Pratik Parikh, MD
-
-
Virginia
-
Richmond, Virginia, United States, 23219
- Recruiting
- Children's Hospital of Richmond
-
Contact:
- Miheret Yitayew, M
- Email: miheret.yitayew@vcuhealth.org
-
Principal Investigator:
- Miheret Yitayew, MD
-
Principal Investigator:
- Edward Springel, MD
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- Recruiting
- University of Wisconsin-Madison
-
Contact:
- Claudette Adegboro, MD
- Email: cadegboro@pediatrics.wisc.edu
-
Principal Investigator:
- Claudette Adegboro, MD
-
Principal Investigator:
- J. Igor Iruretagoyena, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All local births with gestational ages of 22 weeks 0 days - 23 weeks 6 days, regardless of pregnancy outcome or neonatal intensive care (NICU) admission; AND
- All outborn NICU admissions with gestational age at birth of 22 weeks 0 days - 23 weeks 6 days
- Optional: Centers who desire to include data for NICU admissions of infants born <22 weeks' gestation may also submit these data.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Registry of characteristics and outcome data for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation at participating hospitals collected in a uniform manner
Time Frame: Longitudinal database through 1/2028
|
Longitudinal database through 1/2028
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Matthew A Rysavy, MD, PhD, The University of Texas Health Science Center, Houston
Publications and helpful links
General Publications
- Rysavy M, Nakamura T, Mehler K, Agren J, McNamara P, Backes C; Tiny Baby Collaborative. Use of 2.0-mm endotracheal tubes for periviable infants. J Perinatol. 2022 Sep;42(9):1275-1276. doi: 10.1038/s41372-022-01323-7. Epub 2022 Jan 26. No abstract available.
- Rysavy MA, Mehler K, Oberthur A, Agren J, Kusuda S, McNamara PJ, Giesinger RE, Kribs A, Normann E, Carlson SJ, Klein JM, Backes CH, Bell EF. An Immature Science: Intensive Care for Infants Born at </=23 Weeks of Gestation. J Pediatr. 2021 Jun;233:16-25.e1. doi: 10.1016/j.jpeds.2021.03.006. Epub 2021 Mar 7. No abstract available.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-22-0578
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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