Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset

April 28, 2026 updated by: Matthew Rysavy, The University of Texas Health Science Center, Houston
The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation at participating hospitals.

Study Overview

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

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Mater Mother's Hospital
        • Contact:
        • Principal Investigator:
          • Luke Jardine, MD
        • Principal Investigator:
          • Adam Bush, MD
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Not yet recruiting
        • Mercy Hospital for Women
        • Contact:
        • Principal Investigator:
          • Tammy Brinsmead, MD
        • Principal Investigator:
          • Alex Shub, MD
    • Western Australia
      • Perth, Western Australia, Australia, 6008
        • Recruiting
        • King Edward Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Emma Harris, MD
        • Principal Investigator:
          • Scott White, MD
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
        • Not yet recruiting
        • Fraser Health Surrey Memorial Hospital
        • Principal Investigator:
          • Jason Burrows, MD
        • Contact:
        • Principal Investigator:
          • Rebecca Sherlock, MD
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Maya Dahan, MD
        • Principal Investigator:
          • Marie Buitendyk, MD
      • Cologne, Germany
        • Recruiting
        • University of Cologne
        • Contact:
        • Principal Investigator:
          • Katrin Mehler, MD
        • Principal Investigator:
          • Berthold Gruettner, MD
      • Tokyo, Japan
        • Not yet recruiting
        • National Center for Child Health and Development
        • Contact:
        • Principal Investigator:
          • Tetsuya Isayama, MD
        • Principal Investigator:
          • Seiji Wada, MD
    • Mitaka
      • Shinkawa, Mitaka, Japan
        • Recruiting
        • Kyorin University Hospital
        • Contact:
        • Principal Investigator:
          • Kenichiro Hosoi, MD
        • Principal Investigator:
          • Shinji Tanigaki, MD
    • Nagano
      • Azumino, Nagano, Japan
        • Recruiting
        • Nagano Children's Hospital
        • Contact:
        • Principal Investigator:
          • Toshimitsu Yanagisawa, MD
        • Principal Investigator:
          • Shiro Yoshida, MD
    • Osaka
      • Izumi, Osaka, Japan
        • Recruiting
        • Osaka Women's & Children's Hospital
        • Contact:
        • Principal Investigator:
          • Kazuko Wada, MD
        • Principal Investigator:
          • Keisuke Ishii, MD
    • Saitama
      • Kawagoe, Saitama, Japan
        • Recruiting
        • Saitama Medical Center, Saitama Medical University
        • Contact:
        • Principal Investigator:
          • Fumihiko Namba, MD, PhD
        • Principal Investigator:
          • Shinichiro Yabe, MD
    • Tochigi
      • Shimotsuke, Tochigi, Japan
        • Recruiting
        • Jichi Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Yumi Kono, MD
        • Principal Investigator:
          • Hironori Takahashi, MD
      • La Paz, Spain
        • Recruiting
        • La Paz Hospital
        • Contact:
        • Principal Investigator:
          • Gonzalo Solis-Garcia, MD
        • Principal Investigator:
          • Jose Luis Bartha, MD
      • Uppsala, Sweden
        • Recruiting
        • Uppsala University Hospital
        • Contact:
        • Principal Investigator:
          • Johan Agren, MD, PhD
        • Principal Investigator:
          • Maria Jonsson, MD
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Colm Travers, MD
        • Principal Investigator:
          • Ashley Battarbee, MD
      • Mobile, Alabama, United States, 36688
        • Recruiting
        • University of South Alabama
        • Contact:
        • Principal Investigator:
          • Kalsang Dolma, MD
        • Principal Investigator:
          • Amy Hewes, MD
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Recruiting
        • Vallywise Health Medical Center
        • Contact:
        • Principal Investigator:
          • Jason Couch, MD
        • Principal Investigator:
          • Dean Coonrod, MD
    • California
      • Long Beach, California, United States, 90806
        • Recruiting
        • Miller Children's & Women's Hospital
        • Contact:
        • Principal Investigator:
          • Anupama Shetty, MD
        • Principal Investigator:
          • Megan Oakes, MD
      • Orange, California, United States, 92868
        • Recruiting
        • Children's Hospital, Orange County
        • Contact:
        • Principal Investigator:
          • Michel Mikhael, MD
      • San Diego, California, United States, 92093
        • Recruiting
        • University of California, San Diego
        • Contact:
        • Principal Investigator:
          • Katherine Weiss, MD
        • Principal Investigator:
          • Thomas Kelly, MD
    • Florida
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Joe DiMaggio Children's Hospital
        • Contact:
        • 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:
        • Principal Investigator:
          • Erin Burnett, MD
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida, Jacksonville
        • Principal Investigator:
          • Josef Cortez, MD
        • Contact:
        • 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:
        • Principal Investigator:
          • Thais Queliz Pena, MD
      • St. Petersburg, Florida, United States, 33701
        • Recruiting
        • Johns Hopkins All Children's Hospital
        • Contact:
        • Principal Investigator:
          • Mara DiBartolomeo, MD
        • Principal Investigator:
          • Brad Sipe, MD
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Principal Investigator:
          • Ravi Patel, MD
        • Contact:
        • Principal Investigator:
          • Iris Krishna, MD
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Grady Memorial
        • Principal Investigator:
          • Ravi Patel, MD
        • Contact:
        • Principal Investigator:
          • Iris Krishna, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
        • Principal Investigator:
          • Tarah Colaizy, MD
        • Principal Investigator:
          • Mark Santillan, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University Of Kentucky
        • Principal Investigator:
          • John O'Brien, MD
        • Contact:
        • Principal Investigator:
          • Prasad Bhandary, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • 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:
        • Principal Investigator:
          • Cassandra Duffy, MD
      • Boston, Massachusetts, United States, 02120
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
        • Principal Investigator:
          • Laura Bernardini, MD
        • Principal Investigator:
          • Thomas McElrath, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Medicine
        • Contact:
        • 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:
        • 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:
        • Principal Investigator:
          • Noelle Younge, MD
      • Greenville, North Carolina, United States, 27858
        • Recruiting
        • East Carolina University
        • Contact:
        • Principal Investigator:
          • Weili Chang, MD
        • Principal Investigator:
          • James deVente, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Not yet recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Faris Al Garaibeh, MD
        • Principal Investigator:
          • Robert Rossi, MD
      • Columbus, Ohio, United States, 43205
        • Recruiting
        • Nationwide Children's Hospital
        • Contact:
        • 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:
        • Principal Investigator:
          • Brian Scottoline, MD
        • Principal Investigator:
          • Andrew Chon, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Pennsylvania Hospital
        • Contact:
        • Principal Investigator:
          • Dustin Flannery, DO, MSCE
        • Principal Investigator:
          • Haresh Sehdev, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Contact:
        • 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:
        • 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:
        • Principal Investigator:
          • Catherine C Beaullieu, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Contact:
        • Principal Investigator:
          • Shweta Parmekar, MD
        • Principal Investigator:
          • Manisha Gandhi, MD
      • Houston, Texas, United States, 77054
        • Recruiting
        • The Women's Hospital of Texas
        • Contact:
        • Principal Investigator:
          • Kaashif Ahmad, MD
        • Principal Investigator:
          • Anushka Chellia, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • St. Luke's Baptist Hospital
        • Contact:
        • Principal Investigator:
          • Christine Aune, MD
        • Principal Investigator:
          • Randall Davis, MD
      • San Antonio, Texas, United States, 78258
        • Recruiting
        • North Central Baptist Hospital
        • Contact:
        • Principal Investigator:
          • Mary Wearden, MD
        • Principal Investigator:
          • Erin Mankus, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Methodist Children's Hospital
        • Contact:
        • 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:
        • Principal Investigator:
          • Pratik Parikh, MD
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Children's Hospital of Richmond
        • Contact:
        • Principal Investigator:
          • Miheret Yitayew, MD
        • Principal Investigator:
          • Edward Springel, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin-Madison
        • Contact:
        • Principal Investigator:
          • Claudette Adegboro, MD
        • Principal Investigator:
          • J. Igor Iruretagoyena, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 year (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participating hospitals

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Matthew A Rysavy, MD, PhD, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

January 6, 2023

First Posted (Actual)

January 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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