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

NCT ID: NCT05685745

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2028-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infant, Extremely Premature Obstetric Labor, Premature Premature Birth Intensive Care, Neonatal Intensive Care Units, Neonatal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

0 Years

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role collaborator

University of Iowa

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Jichi Medical University

OTHER

Sponsor Role collaborator

Saitama Medical University

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Matthew Rysavy

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew A Rysavy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Site Status RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status RECRUITING

Emory University Grady Memorial

Atlanta, Georgia, United States

Site Status RECRUITING

University of Iowa

Iowa City, Iowa, United States

Site Status RECRUITING

University of Kentucky

Lexington, Kentucky, United States

Site Status RECRUITING

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

University of South Alabama

Mobile, Alabama, United States

Site Status RECRUITING

Vallywise Health Medical Center

Phoenix, Arizona, United States

Site Status RECRUITING

Miller Children's & Women's Hospital

Long Beach, California, United States

Site Status RECRUITING

Children's Hospital, Orange County

Orange, California, United States

Site Status RECRUITING

University of California, San Diego

San Diego, California, United States

Site Status RECRUITING

Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Site Status RECRUITING

Wolfson Children's Hospital

Jacksonville, Florida, United States

Site Status RECRUITING

University of Florida, Jacksonville

Jacksonville, Florida, United States

Site Status RECRUITING

Orlando Health Winnie Palmer Hospital for Women & Babies

Orlando, Florida, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Nebraska Medicine

Omaha, Nebraska, United States

Site Status RECRUITING

The Children's Hospital at Montefiore

The Bronx, New York, United States

Site Status RECRUITING

Duke University

Durham, North Carolina, United States

Site Status RECRUITING

East Carolina University

Greenville, North Carolina, United States

Site Status RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status NOT_YET_RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

Site Status RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Texas Health Resources Harris Hospital

Fort Worth, Texas, United States

Site Status RECRUITING

Texas Children's Hospital

Houston, Texas, United States

Site Status RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

The Women's Hospital of Texas

Houston, Texas, United States

Site Status RECRUITING

CHRISTUS Children's Hospital

San Antonio, Texas, United States

Site Status RECRUITING

Methodist Children's Hospital

San Antonio, Texas, United States

Site Status RECRUITING

St. Luke's Baptist Hospital

San Antonio, Texas, United States

Site Status RECRUITING

North Central Baptist Hospital

San Antonio, Texas, United States

Site Status RECRUITING

Children's Hospital of Richmond

Richmond, Virginia, United States

Site Status RECRUITING

University of Wisconsin-Madison

Madison, Wisconsin, United States

Site Status RECRUITING

Mater Mother's Hospital

South Brisbane, Queensland, Australia

Site Status RECRUITING

Mercy Hospital for Women

Heidelberg, Victoria, Australia

Site Status NOT_YET_RECRUITING

King Edward Memorial Hospital

Perth, Western Australia, Australia

Site Status RECRUITING

Fraser Health Surrey Memorial Hospital

Surrey, British Columbia, Canada

Site Status NOT_YET_RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status RECRUITING

University of Cologne

Cologne, , Germany

Site Status RECRUITING

Kyorin University Hospital

Shinkawa, Mitaka, Japan

Site Status RECRUITING

Nagano Children's Hospital

Azumino, Nagano, Japan

Site Status RECRUITING

Osaka Women's & Children's Hospital

Izumi, Osaka, Japan

Site Status RECRUITING

Saitama Medical Center, Saitama Medical University

Kawagoe, Saitama, Japan

Site Status RECRUITING

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Site Status RECRUITING

National Center for Child Health and Development

Tokyo, , Japan

Site Status NOT_YET_RECRUITING

La Paz Hospital

La Paz, , Spain

Site Status RECRUITING

Uppsala University Hospital

Uppsala, , Sweden

Site Status RECRUITING

Countries

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United States Australia Canada Germany Japan Spain Sweden

Central Contacts

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Matthew A Rysavy, MD, PhD

Role: CONTACT

713-500-5651

Facility Contacts

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Colm Travers, MD

Role: primary

205-934-4680

Kalsang Dolma, MD

Role: primary

Jason Couch, MD

Role: primary

Anupama Shetty, MD

Role: primary

Michel Mikhael, MD

Role: primary

Katherine Weiss, MD

Role: primary

Doron Kahn, MD

Role: primary

Josef Cortez, MD

Role: primary

Josef Cortez, MD

Role: primary

Thais O Queliz Pena, MD

Role: primary

Mara DiBartolomeo, MD

Role: primary

Ravi Patel, MD

Role: primary

Ravi Patel, MD

Role: primary

Tarah Colaizy, MD

Role: primary

319-356-3508

Prasad Bhandary, MD

Role: primary

Laura Bernardini, MD

Role: primary

Laura Bernardini, MD

Role: primary

Helen Healy, MD

Role: primary

Ann Anderson-Berry, MD, PhD

Role: primary

Shantanu Rastogi, MD

Role: primary

Noelle Younge, MD

Role: primary

Weili Chang, MD

Role: primary

Faris Al Garaibeh, MD

Role: primary

Carl H Backes Jr., MD

Role: primary

614-722-3824

Brian Scottoline, MD

Role: primary

Dustin Flannery, DO, MSCE

Role: primary

Dustin Flannery, DO, MSCE

Role: primary

Russell Lawrence, MD

Role: primary

Shweta Parmekar, MD

Role: primary

Catherine C Beaullieu, MD

Role: primary

713-500-5733

Kaashif Ahmad, MD

Role: primary

Pratik Parikh, MD

Role: primary

Katherine Johnson, MD

Role: primary

Christine Aune, MD

Role: primary

Mary Wearden, MD

Role: primary

Miheret Yitayew, M

Role: primary

Claudette Adegboro, MD

Role: primary

Luke Jardine, MD

Role: primary

Tammy Brinsmead, MD

Role: primary

Emma Harris, MD

Role: primary

Rebecca Sherlock, MD

Role: primary

Maya Dahan, MD

Role: primary

Katrin Mehler, MD

Role: primary

Kenichiro Hosoi, MD

Role: primary

Toshimitsu Yanagisawa, MD

Role: primary

Shinya Hirano, MD

Role: primary

Fumihiko Namba, MD, PhD

Role: primary

+81-49-228-3727

Yumi Kono, MD

Role: primary

Tetsuya Isayama, MD

Role: primary

Gonzalo Solis-Garcia, MD

Role: primary

Johan Agren, MD, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 35082430 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33691163 (View on PubMed)

Related Links

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Other Identifiers

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HSC-MS-22-0578

Identifier Type: -

Identifier Source: org_study_id

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