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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Years to 1 Year |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 59 sites (Birmingham, Alabama and 58 other locations) |
| Status | Recruiting |
| Started | January 1, 2019 |
| Main results expected | January 1, 2030 |
| Study ends | January 1, 2030 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT05685745 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
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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
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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.
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UK 22-Week Baby Observation: Learning What Happens for Infants Born at 22 Weeks
This study simply collects and shares de-identified medical notes about babies born at 22 weeks to see how they are cared for and what outcomes occur.
-
A decision support tool for families facing preterm delivery decisions
This study is testing a new tool to help families make better decisions about care for their premature babies born between 22 and 26 weeks of pregnancy.
-
Single dose of corticosteroids for pregnant individuals at risk of preterm delivery
This study is testing if a single lower dose of a corticosteroid can help pregnant people at risk of preterm delivery have healthier babies compared to the usual double dose.
-
Digitally Enabled Districts 2.0: Aimed at Improving Maternal and Neonatal Care in Garut
A stepped-wedge trial tests whether an integrated digital health ecosystem helps 45 local clinics in Garut improve the completeness and timeliness of maternal and neonatal care.
-
Wireless MicroPremVitals Button Sensor for the NICU
This study tests a tiny wireless sensor system to monitor heart rate, oxygen, and temperature in extremely preterm babies in the NICU to see if it works safely without wires.
-
Caffeine in pregnancy: how the mother and baby handle it during delivery
This study tests how caffeine is processed in pregnant people and how much reaches the baby when given shortly before delivery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.