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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05685745

Enrollment

5000

Registered

2023-01-17

Start date

2019-01-01

Completion date

2030-01-01

Last updated

2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to 1 Years

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.

Design outcomes

Primary

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	Longitudinal database through 1/2028

Countries

Australia, Canada, Czechia, Germany, Japan, Spain, Sweden, United States

Contacts

CONTACTMatthew A Rysavy, MD, PhD

Matthew.A.Rysavy@uth.tmc.edu713-500-5651

PRINCIPAL_INVESTIGATORMatthew A Rysavy, MD, PhD

The University of Texas Health Science Center, Houston

Outcome results