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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Enrolling

Conditions

Intensive Care, Neonatal
Infant, Extremely Premature
Obstetric Labor, Premature
Intensive Care Units, Neonatal
Premature Birth

Study type

Observational

Funder types

Other

Identifiers

NCT05685745
HSC-MS-22-0578

Details and patient eligibility

About

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.

Full 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.

Enrollment

5,000 estimated patients

Sex

All

Ages

Under 1 year old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

37

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Central trial contact

Matthew A Rysavy, MD, PhD

Data sourced from clinicaltrials.gov

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