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Clinical Trials/NCT05685745
NCT05685745
Recruiting
Not Applicable

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

The University of Texas Health Science Center, Houston51 sites in 6 countries5,000 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infant, Extremely Premature
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
5000
Locations
51
Primary Endpoint
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
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
January 1, 2028
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matthew Rysavy

Associate Professor

The University of Texas Health Science Center, Houston

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Study Sites (51)

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