NCT05685745

Brief Summary

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
7 countries

51 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2019Jan 2030

Study Start

First participant enrolled

January 1, 2019

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

11 years

First QC Date

January 6, 2023

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Longitudinal database through 1/2028

Eligibility Criteria

Age0 Years - 1 Year
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Participating hospitals

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (51)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

RECRUITING

University of South Alabama

Mobile, Alabama, 36688, United States

RECRUITING

Vallywise Health Medical Center

Phoenix, Arizona, 85008, United States

RECRUITING

Miller Children's & Women's Hospital

Long Beach, California, 90806, United States

RECRUITING

Children's Hospital, Orange County

Orange, California, 92868, United States

RECRUITING

University of California, San Diego

San Diego, California, 92093, United States

RECRUITING

Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

RECRUITING

Wolfson Children's Hospital

Jacksonville, Florida, 32207, United States

RECRUITING

University of Florida, Jacksonville

Jacksonville, Florida, 32209, United States

RECRUITING

Orlando Health Winnie Palmer Hospital for Women & Babies

Orlando, Florida, 32806, United States

RECRUITING

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Emory University Grady Memorial

Atlanta, Georgia, 30322, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Nebraska Medicine

Omaha, Nebraska, 68114, United States

RECRUITING

The Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

RECRUITING

Duke University

Durham, North Carolina, 27708, United States

RECRUITING

East Carolina University

Greenville, North Carolina, 27858, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

NOT YET RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Texas Health Resources Harris Hospital

Fort Worth, Texas, 76104, United States

RECRUITING

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

The Women's Hospital of Texas

Houston, Texas, 77054, United States

RECRUITING

CHRISTUS Children's Hospital

San Antonio, Texas, 78207, United States

RECRUITING

Methodist Children's Hospital

San Antonio, Texas, 78229, United States

RECRUITING

St. Luke's Baptist Hospital

San Antonio, Texas, 78229, United States

RECRUITING

North Central Baptist Hospital

San Antonio, Texas, 78258, United States

RECRUITING

Children's Hospital of Richmond

Richmond, Virginia, 23219, United States

RECRUITING

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

RECRUITING

Mater Mother's Hospital

South Brisbane, Queensland, 4101, Australia

RECRUITING

Mercy Hospital for Women

Heidelberg, Victoria, 3084, Australia

NOT YET RECRUITING

King Edward Memorial Hospital

Perth, Western Australia, 6008, Australia

RECRUITING

Fraser Health Surrey Memorial Hospital

Surrey, British Columbia, V3V 1Z2, Canada

NOT YET RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

University of Cologne

Cologne, Germany

RECRUITING

Kyorin University Hospital

Shinkawa, Mitaka, Japan

RECRUITING

Nagano Children's Hospital

Azumino, Nagano, Japan

RECRUITING

Osaka Women's & Children's Hospital

Izumi, Osaka, Japan

RECRUITING

Saitama Medical Center, Saitama Medical University

Kawagoe, Saitama, Japan

RECRUITING

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

RECRUITING

National Center for Child Health and Development

Tokyo, Japan

NOT YET RECRUITING

La Paz Hospital

La Paz, Spain

RECRUITING

Uppsala University Hospital

Uppsala, Sweden

RECRUITING

Related Publications (2)

  • 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.

    PMID: 35082430BACKGROUND
  • 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.

    PMID: 33691163BACKGROUND

Related Links

MeSH Terms

Conditions

Obstetric Labor, PrematurePremature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Matthew A Rysavy, MD, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew A Rysavy, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 6, 2023

First Posted

January 17, 2023

Study Start

January 1, 2019

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations