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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05685745
Recruitment Status : Recruiting
First Posted : January 17, 2023
Last Update Posted : February 15, 2023
Sponsor:
Collaborators:
Nationwide Children's Hospital
University of Iowa
University of Alabama at Birmingham
Jichi Medical University
Saitama Medical University
Information provided by (Responsible Party):
Matthew Rysavy, The University of Texas Health Science Center, Houston

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Infant, Extremely Premature Obstetric Labor, Premature Premature Birth Intensive Care, Neonatal Intensive Care Units, Neonatal

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2028
Estimated Study Completion Date : January 1, 2028
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   0 Years to 1 Year   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Participating hospitals
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05685745


Contacts
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Contact: Matthew A Rysavy, MD, PhD 713-500-5651 Matthew.A.Rysavy@uth.tmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: Colm Travers, MD    205-934-4680    cptravers@uabmc.edu   
Principal Investigator: Colm Travers, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Edward F Bell, MD    319-356-4006    edward-bell@uiowa.edu   
Principal Investigator: Edward F Bell, MD         
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Carl H Backes Jr., MD    614-722-3824    carl.backes@nationwidechildrens.org   
Principal Investigator: Carl H Backes Jr., MD         
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Catherine C Beaullieu, MD    713-500-5733    Catherine.C.Beaullieu@uth.tmc.edu   
Principal Investigator: Catherine C Beaullieu, MD         
Japan
Saitama Medical Center, Saitama Medical University Recruiting
Kawagoe, Saitama, Japan
Contact: Fumihiko Namba, MD, PhD    +81-49-228-3727    nambaf@saitama-med.ac.jp   
Principal Investigator: Fumihiko Namba, MD, PhD         
Jichi Medical University Hospital Recruiting
Shimotsuke, Tochigi, Japan
Contact: Yumi Kono, MD       ykono@jichi.ac.jp   
Principal Investigator: Yumi Kono, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Nationwide Children's Hospital
University of Iowa
University of Alabama at Birmingham
Jichi Medical University
Saitama Medical University
Investigators
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Principal Investigator: Matthew A Rysavy, MD, PhD The University of Texas Health Science Center, Houston
More Information
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Additional Information:

Publications:

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Responsible Party: Matthew Rysavy, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT05685745    
Other Study ID Numbers: HSC-MS-22-0578
First Posted: January 17, 2023    Key Record Dates
Last Update Posted: February 15, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications