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

June 26, 2023 updated by: Matthew Rysavy, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Mitaka
      • Shinkawa, Mitaka, Japan
        • Recruiting
        • Kyorin University Hospital
        • Contact:
        • Principal Investigator:
          • Kenichiro Hosoi, MD
    • Nagano
      • Azumino, Nagano, Japan
    • Osaka
      • Izumi, Osaka, Japan
        • Recruiting
        • Osaka Women's & Children's Hospital
        • Contact:
        • Principal Investigator:
          • Kazuko Wada, MD
    • Saitama
      • Kawagoe, Saitama, Japan
        • Recruiting
        • Saitama Medical Center, Saitama Medical University
        • Contact:
        • Principal Investigator:
          • Fumihiko Namba, MD, PhD
    • Tochigi
      • Shimotsuke, Tochigi, Japan
        • Recruiting
        • Jichi Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Yumi Kono, MD
  • Sweden
    • Uppland
      • Uppsala, Uppland, Sweden
        • Recruiting
        • Uppsala University Hospital
        • Contact:
        • Principal Investigator:
          • Johan Agren, MD, PhD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Colm Travers, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Principal Investigator:
          • Edward F Bell, MD
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Recruiting
        • Duke University
        • Contact:
        • Principal Investigator:
          • Noelle Younge, MD
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Recruiting
        • Nationwide Children's Hospital
        • Contact:
        • Principal Investigator:
          • Carl H Backes Jr., MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Contact:
        • Principal Investigator:
          • Dustin Flannery, DO, MSCE
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
        • Principal Investigator:
          • Catherine C Beaullieu, MD
      • Houston, Texas, United States, 77054
        • Recruiting
        • The Women's Hospital of Texas
        • Contact:
        • Principal Investigator:
          • Kaashif Ahmad, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 year (Child)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Participating hospitals

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Longitudinal database through 1/2028

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

University of Alabama at Birmingham
University of Iowa
Nationwide Children's Hospital
Jichi Medical University
Saitama Medical University

Investigators

  • Principal Investigator: Matthew A Rysavy, MD, PhD, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

January 6, 2023

First Posted (Actual)

January 17, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-22-0578

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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