Clinical trial Recruiting at 59 sites Observational Ages 0 to 1 Year

Registry of outcomes and practices for extremely premature infants

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

Run by The University of Texas Health Science Center, Houston · NCT05685745 · Data updated 2026-11-12

This study is trying to gather information about the health and care of extremely premature infants born at 22-23 weeks to help improve their treatment and outcomes.

More Premature Birth trials

Quick facts

Study typeObservational
Ages0 Years to 1 Year
SexAll
Enrollment5000 (estimated)
SponsorThe University of Texas Health Science Center, Houston
Academic / other
Locations59 sites (Birmingham, Alabama and 58 other locations)
StatusRecruiting
StartedJanuary 1, 2019
Main results expectedJanuary 1, 2030
Study endsJanuary 1, 2030
Registry record updatedJuly 6, 2026
Trial IDNCT05685745 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study include all infants born at 22-23 weeks' gestation and their mothers, regardless of the outcome.

Probably not a fit

Patients born before 22 weeks' gestation may not receive direct benefits from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset aims to create a comprehensive registry that details the outcomes and practices for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation across participating hospitals. This observational study collects baseline data on mothers and infants, including demographics, health status, medical interventions, and clinical outcomes. The collected data will be utilized for quality improvement reporting, evaluating associations between characteristics and outcomes, and tracking trends in neonatal care.

Why it matters

Potential benefit: If successful, this registry could enhance the understanding of care practices and outcomes for extremely premature infants, leading to improved treatment protocols.

How similar studies have gone: Other studies have successfully utilized similar registry approaches to improve neonatal care, indicating potential for this study's success.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • University of Alabama at Birmingham
    Birmingham, Alabama, United States
    Recruiting
  • University of South Alabama
    Mobile, Alabama, United States
    Recruiting
  • Vallywise Health Medical Center
    Phoenix, Arizona, United States
    Recruiting
  • Loma Linda University Children's Hospital
    Loma Linda, California, United States
    Recruiting
  • Miller Children's & Women's Hospital
    Long Beach, California, United States
    Recruiting
  • Children's Hospital, Orange County
    Orange, California, United States
    Recruiting
Show 44 more locations
  • University of California, San Diego
    San Diego, California, United States
    Recruiting
  • Joe DiMaggio Children's Hospital
    Hollywood, Florida, United States
    Recruiting
  • Wolfson Children's Hospital
    Jacksonville, Florida, United States
    Recruiting
  • University of Florida, Jacksonville
    Jacksonville, Florida, United States
    Recruiting
  • Orlando Health Winnie Palmer Hospital for Women & Babies
    Orlando, Florida, United States
    Recruiting
  • Johns Hopkins All Children's Hospital
    St. Petersburg, Florida, United States
    Recruiting
  • Emory University Hospital Midtown
    Atlanta, Georgia, United States
    Recruiting
  • Emory University Grady Memorial
    Atlanta, Georgia, United States
    Recruiting
  • Memorial Health University Medical Center
    Savannah, Georgia, United States
    Recruiting
  • University of Iowa
    Iowa City, Iowa, United States
    Recruiting
  • Golisano Children's at the University of Kentucky
    Lexington, Kentucky, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Brigham and Women's Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts, United States
    Recruiting
  • Nebraska Medicine
    Omaha, Nebraska, United States
    Recruiting
  • Hackensack University Medical Center
    Hackensack, New Jersey, United States
    Recruiting
  • Golisano Children's Hospital of Buffalo
    Buffalo, New York, United States
    Recruiting
  • The Children's Hospital at Montefiore
    The Bronx, New York, United States
    Recruiting
  • Duke University
    Durham, North Carolina, United States
    Recruiting
  • East Carolina University
    Greenville, North Carolina, United States
    Recruiting
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio, United States
    Recruiting
  • Nationwide Children's Hospital
    Columbus, Ohio, United States
    Recruiting
  • Oregon Health and Science University
    Portland, Oregon, United States
    Recruiting
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania, United States
    Recruiting
  • Pennsylvania Hospital
    Philadelphia, Pennsylvania, United States
    Recruiting
  • Texas Health Resources Harris Hospital
    Fort Worth, Texas, United States
    Recruiting
  • Texas Children's Hospital
    Houston, Texas, United States
    Recruiting
  • The University of Texas Health Science Center at Houston
    Houston, Texas, United States
    Recruiting
  • The Women's Hospital of Texas
    Houston, Texas, United States
    Recruiting
  • CHRISTUS Children's Hospital
    San Antonio, Texas, United States
    Recruiting
  • Methodist Children's Hospital
    San Antonio, Texas, United States
    Recruiting
  • St. Luke's Baptist Hospital
    San Antonio, Texas, United States
    Recruiting
  • North Central Baptist Hospital
    San Antonio, Texas, United States
    Recruiting
  • University of Vermont
    Burlington, Vermont, United States
    Recruiting
  • Children's Hospital of the King's Daughters
    Norfolk, Virginia, United States
    Recruiting
  • Children's Hospital of Richmond
    Richmond, Virginia, United States
    Recruiting
  • University of Wisconsin-Madison
    Madison, Wisconsin, United States
    Recruiting
  • Mater Mother's Hospital
    South Brisbane, Queensland, Australia
    Recruiting
  • Mercy Hospital for Women
    Heidelberg, Victoria, Australia
    Recruiting
  • The Royal Women's Hospital
    Parkville, Victoria, Australia
    Recruiting
  • King Edward Memorial Hospital
    Perth, Western Australia, Australia
    Recruiting
  • Fraser Health Surrey Memorial Hospital
    Surrey, British Columbia, Canada
    Recruiting
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario, Canada
    Recruiting
  • General Faculty Hospital, Prague
    Prague, Czechia
    Recruiting

+9 more sites. See ClinicalTrials.gov for the full list.

Study contacts

  • Principal investigator: Matthew A Rysavy, MD, PhD — The University of Texas Health Science Center, Houston
  • Study coordinator: Matthew A Rysavy, MD, PhD
  • Email: Matthew.A.Rysavy@uth.tmc.edu
  • Phone: 713-500-5651

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.