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

Recruiting
Conditions
Obstetric Labor, Premature
Premature Birth
Infant, Extremely Premature
Intensive Care, Neonatal
Intensive Care Units, Neonatal
Registration Number
NCT05685745
Lead Sponsor
The University of Texas Health Science Center, Houston
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.

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
5000
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.
Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 mannerLongitudinal database through 1/2028
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (37)

University of South Alabama

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Mobile, Alabama, United States

Vallywise Health Medical Center

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Phoenix, Arizona, United States

Miller Children's & Women's Hospital

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Long Beach, California, United States

Children's Hospital, Orange County

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Orange, California, United States

University of California, San Diego

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San Diego, California, United States

University of Florida, Jacksonville

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Jacksonville, Florida, United States

Brigham and Women's Hospital

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Boston, Massachusetts, United States

East Carolina University

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Greenville, North Carolina, United States

Orlando Health Winnie Palmer Hospital for Women & Babies

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Orlando, Florida, United States

Beth Israel Deaconess Medical Center

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Boston, Massachusetts, United States

Emory University

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Atlanta, Georgia, United States

Cincinnati Children's Hospital Medical Center

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Cincinnati, Ohio, United States

Methodist Children's Hospital

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San Antonio, Texas, United States

St. Luke's Baptist Hospital

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San Antonio, Texas, United States

North Central Baptist Hospital

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San Antonio, Texas, United States

Children's Hospital of Richmond

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Richmond, Virginia, United States

University of Wisconsin-Madison

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Madison, Wisconsin, United States

Fraser Health Surrey Memorial Hospital

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Surrey, British Columbia, Canada

University of Cologne

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Cologne, Germany

Oregon Health and Science University

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Portland, Oregon, United States

Texas Children's Hospital

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Houston, Texas, United States

CHRISTUS Children's Hospital

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San Antonio, Texas, United States

National Center for Child Health and Development

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Tokyo, Japan

La Paz Hospital

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La Paz, Spain

University of Alabama at Birmingham

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Birmingham, Alabama, United States

University of Iowa

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Iowa City, Iowa, United States

Duke University

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Durham, North Carolina, United States

Nationwide Children's Hospital

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Columbus, Ohio, United States

University of Pennsylvania

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Philadelphia, Pennsylvania, United States

The University of Texas Health Science Center at Houston

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Houston, Texas, United States

The Women's Hospital of Texas

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Houston, Texas, United States

Kyorin University Hospital

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Shinkawa, Mitaka, Japan

Nagano Children's Hospital

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Azumino, Nagano, Japan

Osaka Women's & Children's Hospital

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Izumi, Osaka, Japan

Saitama Medical Center, Saitama Medical University

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Kawagoe, Saitama, Japan

Jichi Medical University Hospital

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Shimotsuke, Tochigi, Japan

Uppsala University Hospital

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Uppsala, Sweden

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