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Infant, Extremely PrematureNCT05685745

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

An observational study of Infant, Extremely Premature and Obstetric Labor, Premature, run by The University of Texas Health Science Center, Houston at 59 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 0 years to 1 year
How many people
5,000 participants
Where
59 sitesin 8 countries
Study dates
1 Jan 2019to 1 Jan 2030
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 years to 1 year
  • All sexes
  • Child

Study population: Participating hospitals

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

59 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Matthew A Rysavy, MD, PhD contact

713-500-5651

Matthew.A.Rysavy@uth.tmc.edu

59 sites in 8 countries

United States43 sites, 43 recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Ravi Patel, MD, rmpatel@emory.edu

    Ravi Patel, MD

    Recruiting

  • Emory University Grady Memorial

    Atlanta, Georgia, 30322

    Ravi Patel, MD, rmpatel@emory.edu

    Ravi Patel, MD

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

    Colm Travers, MD, 205-934-4680, cptravers@uabmc.edu

    Colm Travers, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Rodica Turcu, MD, rmturcu@mgh.harvard.edu

    Rodica Turcu, MD

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02120

    Laura Bernardini, MD, lbernardini@bwh.harvard.edu

    Laura Bernardini, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Helen Healy, MD, hhealy@bidmc.harvard.edu

    Helen Healy, MD

    Recruiting

  • Golisano Children's Hospital of Buffalo

    Buffalo, New York, 14203

    Kavya Rao, MD, kavyarao@buffalo.edu

    James Shelton, MD, jshelton@buffalo.edu

    Recruiting

  • University of Vermont

    Burlington, Vermont, 05401

    Samuel Loren, MD, 802-847-2370, Samuel.Loren@uvmhealth.org

    Morgan Nealy, Morgan.Nealy@uvmhealth.com

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Faris Al Garaibeh, MD, faris.algharaibeh@cchmc.org

    Faris Al Garaibeh, MD

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Carl H Backes Jr., MD, 614-722-3824, carl.backes@nationwidechildrens.org

    Carl H Backes Jr., MD

    Recruiting

  • Duke University

    Durham, North Carolina, 27708

    Noelle Younge, MD, noelle.younge@duke.edu

    Noelle Younge, MD

    Recruiting

  • Texas Health Resources Harris Hospital

    Fort Worth, Texas, 76104

    Russell Lawrence, MD, russell.lawrence@pediatrix.com

    Russell Lawrence, MD

    Recruiting

  • East Carolina University

    Greenville, North Carolina, 27858

    Weili Chang, MD, changw@ecu.edu

    Weili Chang, MD

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Rakesh Chhabra, MD, rakesh.chhabra@hmhn.org

    Naomi Hanoch, naomi.hanoch@hmhn.org

    Recruiting

  • Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

    Doron Kahn, MD, DKahn@mhs.net

    Doron Kahn, MD

    Recruiting

  • Texas Children's Hospital

    Houston, Texas, 77030

    Shweta Parmekar, MD, ssparmek@texaschildrens.org

    Shweta Parmekar, MD

    Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Catherine C Beaullieu, MD, 713-500-5733, Catherine.C.Beaullieu@uth.tmc.edu

    Catherine C Beaullieu, MD

    Recruiting

  • The Women's Hospital of Texas

    Houston, Texas, 77054

    Kaashif Ahmad, MD, kahmad@uh.edu

    Kaashif Ahmad, MD

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Tarah Colaizy, MD, 319-356-3508, tarah-colaizy@uiowa.edu

    Tarah Colaizy, MD

    Recruiting

  • Wolfson Children's Hospital

    Jacksonville, Florida, 32207

    Vasantha Kumar, MD, vasantha.kumar@jax.ufl.edu

    Vasantha Kumar, MD

    Recruiting

  • University of Florida, Jacksonville

    Jacksonville, Florida, 32209

    Vasantha Kumar, MD, vasantha.kumar@jax.ufl.edu

    Vasantha Kumar, MD

    Recruiting

  • Golisano Children's at the University of Kentucky

    Lexington, Kentucky, 40536

    Prasad Bhandary, MD, prasad.bhandary@uky.edu

    Prasad Bhandary, MD

    Recruiting

  • Loma Linda University Children's Hospital

    Loma Linda, California, 92354

    Anamika Banerji, MD, 877-558-6248, ABanerji@llu.edu

    Andrew Hopper, MD, ahopper@llu.edu

    Recruiting

  • Miller Children's & Women's Hospital

    Long Beach, California, 90806

    Anupama Shetty, MD, ashetty@memorialcare.org

    Anupama Shetty, MD

    Recruiting

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53792

    Claudette Onyelobi, MD, cadegboro@pediatrics.wisc.edu

    Claudette Onyelobi, MD

    Recruiting

  • University of South Alabama

    Mobile, Alabama, 36688

    Kalsang Dolma, MD, kdolma@health.southalabama.edu

    Kalsang Dolma, MD

    Recruiting

  • Children's Hospital of the King's Daughters

    Norfolk, Virginia, 23507

    Kaitlin Ryan-Smith, MD, 1-757-668-7456, kaitlin.ryan-smith@chkd.org

    Laura Warner

    Recruiting

  • Nebraska Medicine

    Omaha, Nebraska, 68114

    Ann Anderson-Berry, MD, PhD, alanders@unmc.edu

    Ann Anderson-Berry, MD, PhD

    Recruiting

  • Children's Hospital, Orange County

    Orange, California, 92868

    Michel Mikhael, MD, MMikhael@choc.org

    Michel Mikhael, MD

    Recruiting

  • Orlando Health Winnie Palmer Hospital for Women & Babies

    Orlando, Florida, 32806

    Thais O Queliz Pena, MD, Thais.QuelizPena@orlandohealth.com

    Thais Queliz Pena, MD

    Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Dustin Flannery, DO, MSCE, Flanneryd@chop.edu

    Dustin Flannery, DO, MSCE

    Recruiting

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

    Dustin Flannery, DO, MSCE, flanneryd@chop.edu

    Dustin Flannery, DO, MSCE

    Recruiting

  • Vallywise Health Medical Center

    Phoenix, Arizona, 85008

    Jason Couch, MD, jason_couch@dmgaz.org

    Jason Couch, MD

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Brian Scottoline, MD, scottoli@ohsu.edu

    Brian Scottoline, MD

    Recruiting

  • Children's Hospital of Richmond

    Richmond, Virginia, 23219

    Miheret Yitayew, M, miheret.yitayew@vcuhealth.org

    Miheret Yitayew, MD

    Recruiting

  • CHRISTUS Children's Hospital

    San Antonio, Texas, 78207

    Pratik Parikh, MD, pratik.parikh@pediatrix.com

    Pratik Parikh, MD

    Recruiting

  • Methodist Children's Hospital

    San Antonio, Texas, 78229

    Katherine Johnson, MD, katherine.m.johnson@pediatrix.com

    Katherine Johnson, MD

    Recruiting

  • St. Luke's Baptist Hospital

    San Antonio, Texas, 78229

    Christine Aune, MD, christine.aune@pediatrix.com

    Christine Aune, MD

    Recruiting

  • North Central Baptist Hospital

    San Antonio, Texas, 78258

    Mary Wearden, MD, mary.wearden@pediatrix.com

    Mary Wearden, MD

    Recruiting

  • University of California, San Diego

    San Diego, California, 92093

    Katherine Weiss, MD, kaweiss@health.ucsd.edu

    Katherine Weiss, MD

    Recruiting

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

    Bradley Buckler, MD, 912-350-5915, bradley.buckler@pediatrix.com

    Suzanne Kirkeby, suzanne.kirkeby@hcahealthcare.com

    Recruiting

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701

    Mara DiBartolomeo, MD, mdibart2@jhmi.edu

    Mara DiBartolomeo, MD

    Recruiting

  • The Children's Hospital at Montefiore

    The Bronx, New York, 10467

    Shantanu Rastogi, MD, shrastogi@montefiore.org

    Shantanu Rastogi, MD

    Recruiting

Other trials in United States

Japan6 sites, 6 recruiting

  • Nagano Children's Hospital

    Azumino, Nagano

    Toshimitsu Yanagisawa, MD, toshimitsu-yanagisawa@nkodomo-hsp.jp

    Toshimitsu Yanagisawa, MD

    Recruiting

  • Osaka Women's & Children's Hospital

    Izumi, Osaka

    Shinya Hirano, MD, shirano@wch.opho.jp

    Kazuko Wada, MD

    Recruiting

  • Saitama Medical Center, Saitama Medical University

    Kawagoe, Saitama

    Fumihiko Namba, MD, PhD, +81-49-228-3727, nambaf@saitama-med.ac.jp

    Fumihiko Namba, MD, PhD

    Recruiting

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi

    Yumi Kono, MD, ykono@jichi.ac.jp

    Yumi Kono, MD

    Recruiting

  • Kyorin University Hospital

    Shinkawa, Mitaka

    Kenichiro Hosoi, MD, hosoi-k@ks.kyorin-u.ac.jp

    Kenichiro Hosoi, MD

    Recruiting

  • National Center for Child Health and Development

    Tokyo

    Tetsuya Isayama, MD, isayama77@gmail.com

    Tetsuya Isayama, MD

    Recruiting

Other trials in Japan

Australia4 sites, 4 recruiting

  • Mercy Hospital for Women

    Heidelberg, Victoria, 3084

    Tammy Brinsmead, MD, BrinsT@mercy.com.au

    Tammy Brinsmead, MD

    Recruiting

  • The Royal Women's Hospital

    Parkville, Victoria, 3052

    Jennifer Walsh, MD, 03 8345 2000, jennifer.walsh@thewomens.org.au

    Kate Hodgson, MD, 03 8345 2000, kate.hodgson@thewomens.org.au

    Recruiting

  • King Edward Memorial Hospital

    Perth, Western Australia, 6008

    Emma Harris, MD, Emma.Harris@health.wa.gov.au

    Emma Harris, MD

    Recruiting

  • Mater Mother's Hospital

    South Brisbane, Queensland, 4101

    Luke Jardine, MD, Luke.Jardine@mater.org.au

    Luke Jardine, MD

    Recruiting

Other trials in Australia

Canada2 sites, 2 recruiting

  • Fraser Health Surrey Memorial Hospital

    Surrey, British Columbia, V3V 1Z2

    Rebecca Sherlock, MD, rebecca.sherlock@fraserhealth.ca

    Rebecca Sherlock, MD

    Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Maya Dahan, MD, maya.dahan@sunnybrook.ca

    Maya Dahan, MD

    Recruiting

Other trials in Canada

Czechia1 site, 1 recruiting

  • General Faculty Hospital, Prague

    Prague

    Richard Plavka, MUDr, 420 224 961 111, richard.plavka@vfn.cz

    Tereza Lamberska, MUDr, 420 224 961 111, tereza.lamberska@vfn.cz

    Recruiting

Other trials in Czechia

Germany1 site, 1 recruiting

  • University of Cologne

    Cologne

    Katrin Mehler, MD, Katrin.mehler@uk-koeln.de

    Katrin Mehler, MD

    Recruiting

Other trials in Germany

Spain1 site, 1 recruiting

  • La Paz Hospital

    La Paz

    Gonzalo Solis-Garcia, MD, gonzalo.solis@salud.madrid.org

    Gonzalo Solis-Garcia, MD

    Recruiting

Other trials in Spain

Sweden1 site, 1 recruiting

  • Uppsala University Hospital

    Uppsala

    Johan Agren, MD, PhD, johan.agren@kbh.uu.se

    Johan Agren, MD, PhD

    Recruiting

Other trials in Sweden

About this study

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.

Read the 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.

Medical subject headings
Obstetric Labor, Premature, Premature Birth

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Longitudinal database through 1/2028

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2023
  2. Study start1 Jan 2019
  3. Primary completion1 Jan 2030 (estimated)
  4. Study completion1 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT05685745
Sponsor's protocol ID
HSC-MS-22-0578
Status last verified
Apr 2026
First submitted
6 Jan 2023
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35082430

  • 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.

    PubMed 33691163

Questions about this trial

What is this clinical trial studying?

An observational study of Infant, Extremely Premature and Obstetric Labor, Premature, run by The University of Texas Health Science Center, Houston at 59 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Japan, Australia, Canada, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Matthew A Rysavy, MD, PhD (713-500-5651, Matthew.A.Rysavy@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05685745, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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