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RecruitingNCT05685745Updated Jul 6, 2026

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

An observational study in Infant, Extremely Premature, Obstetric Labor, Premature and Premature Birth, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 59 sites in 8 countries. Open to participants aged 0 Years to 1 Year. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by The University of Texas Health Science Center, Houston · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
0 Years to 1 Year
Sex
All
01

Study 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 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.

02

Conditions studied

  • Infant, Extremely Premature
  • Obstetric Labor, Premature
  • Premature Birth
  • Intensive Care, Neonatal
  • Intensive Care Units, Neonatal
03

Who can participate

Ages eligible
0 Years to 1 Year
Sexes eligible
All
Sampling method
Probability sample

Study population

Participating hospitals

Eligibility 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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
05

What researchers measure

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

    Time frame: Longitudinal database through 1/2028

06

Study locations

59 of 59 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35249, United States
    • Colm Travers, MD · Contact · cptravers@uabmc.edu · 205-934-4680
    • Colm Travers, MD · Principal investigator
    • Ashley Battarbee, MD · Principal investigator
    Recruiting
  • University of South Alabama
    Mobile, Alabama 36688, United States
    Recruiting
  • Vallywise Health Medical Center
    Phoenix, Arizona 85008, United States
    • Jason Couch, MD · Contact · jason_couch@dmgaz.org
    • Jason Couch, MD · Principal investigator
    • Dean Coonrod, MD · Principal investigator
    Recruiting
  • Loma Linda University Children's Hospital
    Loma Linda, California 92354, United States
    • Anamika Banerji, MD · Contact · ABanerji@llu.edu · 877-558-6248
    • Andrew Hopper, MD · Contact · ahopper@llu.edu
    • Anamika Banerji, MD · Principal investigator
    • Andrew Hopper, MD · Sub investigator
    Recruiting
  • Miller Children's & Women's Hospital
    Long Beach, California 90806, United States
    • Anupama Shetty, MD · Contact · ashetty@memorialcare.org
    • Anupama Shetty, MD · Principal investigator
    • Megan Oakes, MD · Principal investigator
    Recruiting
  • Children's Hospital, Orange County
    Orange, California 92868, United States
    • Michel Mikhael, MD · Contact · MMikhael@choc.org
    • Michel Mikhael, MD · Principal investigator
    Recruiting
  • University of California, San Diego
    San Diego, California 92093, United States
    • Katherine Weiss, MD · Contact · kaweiss@health.ucsd.edu
    • Katherine Weiss, MD · Principal investigator
    • Thomas Kelly, MD · Principal investigator
    Recruiting
  • Joe DiMaggio Children's Hospital
    Hollywood, Florida 33021, United States
    • Doron Kahn, MD · Contact · DKahn@mhs.net
    • Doron Kahn, MD · Principal investigator
    • Elvire Jacques, MD · Principal investigator
    Recruiting
  • Wolfson Children's Hospital
    Jacksonville, Florida 32207, United States
    • Vasantha Kumar, MD · Contact · vasantha.kumar@jax.ufl.edu
    • Vasantha Kumar, MD · Principal investigator
    • Erin Burnett, MD · Principal investigator
    Recruiting
  • University of Florida, Jacksonville
    Jacksonville, Florida 32209, United States
    • Vasantha Kumar, MD · Contact · vasantha.kumar@jax.ufl.edu
    • Vasantha Kumar, MD · Principal investigator
    • Erin Burnett, MD · Principal investigator
    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
    • Mara DiBartolomeo, MD · Contact · mdibart2@jhmi.edu
    • Mara DiBartolomeo, MD · Principal investigator
    • Brad Sipe, MD · Principal investigator
    Recruiting
  • Emory University Hospital Midtown
    Atlanta, Georgia 30308, United States
    • Ravi Patel, MD · Contact · rmpatel@emory.edu
    • Ravi Patel, MD · Principal investigator
    • Iris Krishna, MD · Principal investigator
    Recruiting
  • Emory University Grady Memorial
    Atlanta, Georgia 30322, United States
    • Ravi Patel, MD · Contact · rmpatel@emory.edu
    • Ravi Patel, MD · Principal investigator
    • Iris Krishna, MD · Principal investigator
    Recruiting
  • Memorial Health University Medical Center
    Savannah, Georgia 31404, United States
    Recruiting
  • University of Iowa
    Iowa City, Iowa 52242, United States
    • Tarah Colaizy, MD · Contact · tarah-colaizy@uiowa.edu · 319-356-3508
    • Tarah Colaizy, MD · Principal investigator
    • Mark Santillan, MD · Principal investigator
    Recruiting
  • Golisano Children's at the University of Kentucky
    Lexington, Kentucky 40536, United States
    • Prasad Bhandary, MD · Contact · prasad.bhandary@uky.edu
    • Prasad Bhandary, MD · Principal investigator
    • John O'Brien, MD · Principal investigator
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    Recruiting
  • Brigham and Women's Hospital
    Boston, Massachusetts 02120, United States
    • Laura Bernardini, MD · Contact · lbernardini@bwh.harvard.edu
    • Laura Bernardini, MD · Principal investigator
    • Thomas McElrath, MD · Principal investigator
    Recruiting
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
    • Helen Healy, MD · Contact · hhealy@bidmc.harvard.edu
    • Helen Healy, MD · Principal investigator
    • Cassandra Duffy, MD · Principal investigator
    Recruiting
  • Nebraska Medicine
    Omaha, Nebraska 68114, United States
    • Ann Anderson-Berry, MD, PhD · Contact · alanders@unmc.edu
    • Ann Anderson-Berry, MD, PhD · Principal investigator
    • Rebecca Rimsza, MD · Principal investigator
    Recruiting
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
    Recruiting
  • Golisano Children's Hospital of Buffalo
    Buffalo, New York 14203, United States
    Recruiting
  • The Children's Hospital at Montefiore
    The Bronx, New York 10467, United States
    • Shantanu Rastogi, MD · Contact · shrastogi@montefiore.org
    • Shantanu Rastogi, MD · Principal investigator
    • Rodney Wright, MD · Principal investigator
    Recruiting
  • Duke University
    Durham, North Carolina 27708, United States
    • Noelle Younge, MD · Contact · noelle.younge@duke.edu
    • Noelle Younge, MD · Principal investigator
    • Brenna Hughes, MD · Principal investigator
    Recruiting
  • East Carolina University
    Greenville, North Carolina 27858, United States
    • Weili Chang, MD · Contact · changw@ecu.edu
    • Weili Chang, MD · Principal investigator
    • James deVente, MD · Principal investigator
    Recruiting
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
    • Faris Al Garaibeh, MD · Contact · faris.algharaibeh@cchmc.org
    • Faris Al Garaibeh, MD · Principal investigator
    • Robert Rossi, MD · Principal investigator
    Recruiting
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
    Recruiting
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
    • Brian Scottoline, MD · Contact · scottoli@ohsu.edu
    • Brian Scottoline, MD · Principal investigator
    • Andrew Chon, MD · Principal investigator
    Recruiting
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
    • Dustin Flannery, DO, MSCE · Contact · Flanneryd@chop.edu
    • Dustin Flannery, DO, MSCE · Principal investigator
    • Harish Sehdev, MD · Principal investigator
    Recruiting
  • Pennsylvania Hospital
    Philadelphia, Pennsylvania 19107, United States
    • Dustin Flannery, DO, MSCE · Contact · flanneryd@chop.edu
    • Dustin Flannery, DO, MSCE · Principal investigator
    • Haresh Sehdev, MD · Principal investigator
    Recruiting
  • Texas Health Resources Harris Hospital
    Fort Worth, Texas 76104, United States
    Recruiting
  • Texas Children's Hospital
    Houston, Texas 77030, United States
    • Shweta Parmekar, MD · Contact · ssparmek@texaschildrens.org
    • Shweta Parmekar, MD · Principal investigator
    • Manisha Gandhi, MD · Principal investigator
    Recruiting
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
    • Catherine C Beaullieu, MD · Contact · Catherine.C.Beaullieu@uth.tmc.edu · 713-500-5733
    • Catherine C Beaullieu, MD · Principal investigator
    • Hector Mendez-Figueroa, MD · Principal investigator
    Recruiting
  • The Women's Hospital of Texas
    Houston, Texas 77054, United States
    • Kaashif Ahmad, MD · Contact · kahmad@uh.edu
    • Kaashif Ahmad, MD · Principal investigator
    • Anushka Chellia, MD · Principal investigator
    Recruiting
  • CHRISTUS Children's Hospital
    San Antonio, Texas 78207, United States
    • Pratik Parikh, MD · Contact · pratik.parikh@pediatrix.com
    • Pratik Parikh, MD · Principal investigator
    • James Hill, MD · Principal investigator
    Recruiting
  • Methodist Children's Hospital
    San Antonio, Texas 78229, United States
    • Katherine Johnson, MD · Contact · katherine.m.johnson@pediatrix.com
    • Katherine Johnson, MD · Principal investigator
    • Elizabeth De La Garza, MD · Principal investigator
    Recruiting
  • St. Luke's Baptist Hospital
    San Antonio, Texas 78229, United States
    • Christine Aune, MD · Contact · christine.aune@pediatrix.com
    • Christine Aune, MD · Principal investigator
    • Randall Davis, MD · Principal investigator
    Recruiting
  • North Central Baptist Hospital
    San Antonio, Texas 78258, United States
    • Mary Wearden, MD · Contact · mary.wearden@pediatrix.com
    • Mary Wearden, MD · Principal investigator
    • Erin Mankus, MD · Principal investigator
    Recruiting
  • University of Vermont
    Burlington, Vermont 05401, United States
    Recruiting
  • Children's Hospital of the King's Daughters
    Norfolk, Virginia 23507, United States
    • Kaitlin Ryan-Smith, MD · Contact · kaitlin.ryan-smith@chkd.org · 1-757-668-7456
    • Laura Warner · Contact
    • Kaitlin Ryan-Smith, MD · Principal investigator
    Recruiting
  • Children's Hospital of Richmond
    Richmond, Virginia 23219, United States
    • Miheret Yitayew, M · Contact · miheret.yitayew@vcuhealth.org
    • Miheret Yitayew, MD · Principal investigator
    • Edward Springel, MD · Principal investigator
    Recruiting
  • University of Wisconsin-Madison
    Madison, Wisconsin 53792, United States
    • Claudette Onyelobi, MD · Contact · cadegboro@pediatrics.wisc.edu
    • Claudette Onyelobi, MD · Principal investigator
    • J. Igor Iruretagoyena, MD · Principal investigator
    Recruiting
  • Mater Mother's Hospital
    South Brisbane, Queensland 4101, Australia
    • Luke Jardine, MD · Contact · Luke.Jardine@mater.org.au
    • Luke Jardine, MD · Principal investigator
    • Adam Bush, MD · Principal investigator
    Recruiting
  • Mercy Hospital for Women
    Heidelberg, Victoria 3084, Australia
    • Tammy Brinsmead, MD · Contact · BrinsT@mercy.com.au
    • Tammy Brinsmead, MD · Principal investigator
    • Alex Shub, MD · Principal investigator
    Recruiting
  • The Royal Women's Hospital
    Parkville, Victoria 3052, Australia
    Recruiting
  • King Edward Memorial Hospital
    Perth, Western Australia 6008, Australia
    • Emma Harris, MD · Contact · Emma.Harris@health.wa.gov.au
    • Emma Harris, MD · Principal investigator
    • Scott White, MD · Principal investigator
    Recruiting
  • Fraser Health Surrey Memorial Hospital
    Surrey, British Columbia V3V 1Z2, Canada
    Recruiting
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario M4N 3M5, Canada
    • Maya Dahan, MD · Contact · maya.dahan@sunnybrook.ca
    • Maya Dahan, MD · Principal investigator
    • Marie Buitendyk, MD · Principal investigator
    Recruiting
  • General Faculty Hospital, Prague
    Prague, Czechia
    • Richard Plavka, MUDr · Contact · richard.plavka@vfn.cz · 420 224 961 111
    • Tereza Lamberska, MUDr · Contact · tereza.lamberska@vfn.cz · 420 224 961 111
    • Richard Plavka, MD · Principal investigator
    • Tereza Lamberska, MD · Sub investigator
    Recruiting
  • University of Cologne
    Cologne, Germany
    • Katrin Mehler, MD · Contact · Katrin.mehler@uk-koeln.de
    • Katrin Mehler, MD · Principal investigator
    • Berthold Gruettner, MD · Principal investigator
    Recruiting
  • Kyorin University Hospital
    Shinkawa, Mitaka, Japan
    • Kenichiro Hosoi, MD · Contact · hosoi-k@ks.kyorin-u.ac.jp
    • Kenichiro Hosoi, MD · Principal investigator
    • Shinji Tanigaki, MD · Principal investigator
    Recruiting
  • Nagano Children's Hospital
    Azumino, Nagano, Japan
    Recruiting
  • Osaka Women's & Children's Hospital
    Izumi, Osaka, Japan
    • Shinya Hirano, MD · Contact · shirano@wch.opho.jp
    • Kazuko Wada, MD · Principal investigator
    • Keisuke Ishii, MD · Principal investigator
    Recruiting
  • Saitama Medical Center, Saitama Medical University
    Kawagoe, Saitama, Japan
    • Fumihiko Namba, MD, PhD · Contact · nambaf@saitama-med.ac.jp · +81-49-228-3727
    • Fumihiko Namba, MD, PhD · Principal investigator
    • Shinichiro Yabe, MD · Principal investigator
    Recruiting
  • Jichi Medical University Hospital
    Shimotsuke, Tochigi, Japan
    • Yumi Kono, MD · Contact · ykono@jichi.ac.jp
    • Yumi Kono, MD · Principal investigator
    • Hironori Takahashi, MD · Principal investigator
    Recruiting
  • National Center for Child Health and Development
    Tokyo, Japan
    • Tetsuya Isayama, MD · Contact · isayama77@gmail.com
    • Tetsuya Isayama, MD · Principal investigator
    • Seiji Wada, MD · Principal investigator
    Recruiting
  • La Paz Hospital
    La Paz, Spain
    • Gonzalo Solis-Garcia, MD · Contact · gonzalo.solis@salud.madrid.org
    • Gonzalo Solis-Garcia, MD · Principal investigator
    • Jose Luis Bartha, MD · Principal investigator
    Recruiting
  • Uppsala University Hospital
    Uppsala, Sweden
    • Johan Agren, MD, PhD · Contact · johan.agren@kbh.uu.se
    • Johan Agren, MD, PhD · Principal investigator
    • Maria Jonsson, MD · Principal investigator
    Recruiting
07

References and documents

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 ↗

Related links

08

Registry details

Key details

Study ID
NCT05685745
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborators
Nationwide Children's Hospital, University of Iowa, University of Alabama at Birmingham, Jichi Medical University, Saitama Medical University
Responsible party
Matthew Rysavy (Associate Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Jan 17, 2023
Start date
Jan 1, 2019
Primary completion
Jan 1, 2030 (estimated)
Completion
Jan 1, 2030 (estimated)
Last update
Jul 6, 2026

Study contacts

Matthew A Rysavy, MD, PhD
Contact
Matthew.A.Rysavy@uth.tmc.edu
713-500-5651
Matthew A Rysavy, MD, PhD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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