Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT05685745

Conditions

Infant, Extremely Premature

Obstetric Labor, Premature

Premature Birth

Intensive Care, Neonatal

Intensive Care Units, Neonatal

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Infant, Extremely Premature

Obstetric Labor, Premature

Premature Birth

Intensive Care, Neonatal

Intensive Care Units, Neonatal

Study ID

NCT05685745

Start date

Jan 1, 2019

Status verified date

Apr, 2026

Completion date

Jan 1, 2030

Anticipated

Primary completion date

Jan 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

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 ]

Central Contacts and Locations

Central contacts

Matthew A Rysavy, MD, PhD

713-500-5651Matthew.A.Rysavy@uth.tmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35249

Contacts

Colm Travers, MD

205-934-4680cptravers@uabmc.edu

Principal Investigator:

Colm Travers, MD

University of South Alabama

Recruiting

Mobile, Alabama, United States, 36688

Contacts

Kalsang Dolma, MD

kdolma@health.southalabama.edu

Principal Investigator:

Kalsang Dolma, MD

Vallywise Health Medical Center

Recruiting

Phoenix, Arizona, United States, 85008

Contacts

Jason Couch, MD

jason_couch@dmgaz.org

Principal Investigator:

Jason Couch, MD

Loma Linda University Children's Hospital

Recruiting

Loma Linda, California, United States, 92354

Contacts

Anamika Banerji, MD

877-558-6248ABanerji@llu.edu

Andrew Hopper, MD

ahopper@llu.edu

Principal Investigator:

Anamika Banerji, MD

Miller Children's & Women's Hospital

Recruiting

Long Beach, California, United States, 90806

Contacts

Anupama Shetty, MD

ashetty@memorialcare.org

Principal Investigator:

Anupama Shetty, MD

Children's Hospital, Orange County

Recruiting

Orange, California, United States, 92868

Contacts

Michel Mikhael, MD

MMikhael@choc.org

Principal Investigator:

Michel Mikhael, MD

University of California, San Diego

Recruiting

San Diego, California, United States, 92093

Contacts

Katherine Weiss, MD

kaweiss@health.ucsd.edu

Principal Investigator:

Katherine Weiss, MD

Joe DiMaggio Children's Hospital

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Doron Kahn, MD

DKahn@mhs.net

Principal Investigator:

Doron Kahn, MD

Wolfson Children's Hospital

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Vasantha Kumar, MD

vasantha.kumar@jax.ufl.edu

Principal Investigator:

Vasantha Kumar, MD

University of Florida, Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Vasantha Kumar, MD

vasantha.kumar@jax.ufl.edu

Principal Investigator:

Vasantha Kumar, MD

Orlando Health Winnie Palmer Hospital for Women & Babies

Recruiting

Orlando, Florida, United States, 32806

Contacts

Thais O Queliz Pena, MD

Thais.QuelizPena@orlandohealth.com

Principal Investigator:

Thais Queliz Pena, MD

Johns Hopkins All Children's Hospital

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Mara DiBartolomeo, MD

mdibart2@jhmi.edu

Principal Investigator:

Mara DiBartolomeo, MD

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Ravi Patel, MD

rmpatel@emory.edu

Principal Investigator:

Ravi Patel, MD

Emory University Grady Memorial

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Ravi Patel, MD

rmpatel@emory.edu

Principal Investigator:

Ravi Patel, MD

Memorial Health University Medical Center

Recruiting

Savannah, Georgia, United States, 31404

Contacts

Bradley Buckler, MD

912-350-5915bradley.buckler@pediatrix.com

Suzanne Kirkeby

suzanne.kirkeby@hcahealthcare.com

Principal Investigator:

Bradley Buckler, MD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Tarah Colaizy, MD

319-356-3508tarah-colaizy@uiowa.edu

Principal Investigator:

Tarah Colaizy, MD

Golisano Children's at the University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Prasad Bhandary, MD

prasad.bhandary@uky.edu

Principal Investigator:

Prasad Bhandary, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Rodica Turcu, MD

rmturcu@mgh.harvard.edu

Principal Investigator:

Rodica Turcu, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02120

Contacts

Laura Bernardini, MD

lbernardini@bwh.harvard.edu

Principal Investigator:

Laura Bernardini, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Helen Healy, MD

hhealy@bidmc.harvard.edu

Principal Investigator:

Helen Healy, MD

Nebraska Medicine

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Ann Anderson-Berry, MD, PhD

alanders@unmc.edu

Principal Investigator:

Ann Anderson-Berry, MD, PhD

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Rakesh Chhabra, MD

rakesh.chhabra@hmhn.org

Naomi Hanoch

naomi.hanoch@hmhn.org

Principal Investigator:

Rakesh Chhabra, MD

Golisano Children's Hospital of Buffalo

Recruiting

Buffalo, New York, United States, 14203

Contacts

Kavya Rao, MD

kavyarao@buffalo.edu

James Shelton, MD

jshelton@buffalo.edu

Principal Investigator:

Kavya Rao, MD

The Children's Hospital at Montefiore

Recruiting

The Bronx, New York, United States, 10467

Contacts

Shantanu Rastogi, MD

shrastogi@montefiore.org

Principal Investigator:

Shantanu Rastogi, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27708

Contacts

Noelle Younge, MD

noelle.younge@duke.edu

Principal Investigator:

Noelle Younge, MD

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27858

Contacts

Weili Chang, MD

changw@ecu.edu

Principal Investigator:

Weili Chang, MD

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Faris Al Garaibeh, MD

faris.algharaibeh@cchmc.org

Principal Investigator:

Faris Al Garaibeh, MD

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Carl H Backes Jr., MD

614-722-3824carl.backes@nationwidechildrens.org

Principal Investigator:

Carl H Backes Jr., MD

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Brian Scottoline, MD

scottoli@ohsu.edu

Principal Investigator:

Brian Scottoline, MD

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Dustin Flannery, DO, MSCE

Flanneryd@chop.edu

Principal Investigator:

Dustin Flannery, DO, MSCE

Pennsylvania Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Dustin Flannery, DO, MSCE

flanneryd@chop.edu

Principal Investigator:

Dustin Flannery, DO, MSCE

Texas Health Resources Harris Hospital

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Russell Lawrence, MD

russell.lawrence@pediatrix.com

Principal Investigator:

Russell Lawrence, MD

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Shweta Parmekar, MD

ssparmek@texaschildrens.org

Principal Investigator:

Shweta Parmekar, MD

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Catherine C Beaullieu, MD

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

Principal Investigator:

Catherine C Beaullieu, MD

The Women's Hospital of Texas

Recruiting

Houston, Texas, United States, 77054

Contacts

Kaashif Ahmad, MD

kahmad@uh.edu

Principal Investigator:

Kaashif Ahmad, MD

CHRISTUS Children's Hospital

Recruiting

San Antonio, Texas, United States, 78207

Contacts

Pratik Parikh, MD

pratik.parikh@pediatrix.com

Principal Investigator:

Pratik Parikh, MD

Methodist Children's Hospital

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Katherine Johnson, MD

katherine.m.johnson@pediatrix.com

Principal Investigator:

Katherine Johnson, MD

St. Luke's Baptist Hospital

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Christine Aune, MD

christine.aune@pediatrix.com

Principal Investigator:

Christine Aune, MD

North Central Baptist Hospital

Recruiting

San Antonio, Texas, United States, 78258

Contacts

Mary Wearden, MD

mary.wearden@pediatrix.com

Principal Investigator:

Mary Wearden, MD

University of Vermont

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Samuel Loren, MD

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

Morgan Nealy

Morgan.Nealy@uvmhealth.com

Children's Hospital of the King's Daughters

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Kaitlin Ryan-Smith, MD

1-757-668-7456kaitlin.ryan-smith@chkd.org

Principal Investigator:

Kaitlin Ryan-Smith, MD

Children's Hospital of Richmond

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Miheret Yitayew, M

miheret.yitayew@vcuhealth.org

Principal Investigator:

Miheret Yitayew, MD

University of Wisconsin-Madison

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Claudette Onyelobi, MD

cadegboro@pediatrics.wisc.edu

Principal Investigator:

Claudette Onyelobi, MD

Fraser Health Surrey Memorial Hospital

Recruiting

Surrey, British Columbia, Canada, V3V 1Z2

Contacts

Rebecca Sherlock, MD

rebecca.sherlock@fraserhealth.ca

Principal Investigator:

Rebecca Sherlock, MD

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Maya Dahan, MD

maya.dahan@sunnybrook.ca

Principal Investigator:

Maya Dahan, MD

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jul 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-07-06.