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

Recruiting

• Conditions: Obstetric Labor, Premature; Premature Birth; Infant, Extremely Premature; Intensive Care, Neonatal; Intensive Care Units, Neonatal

• Registration Number: NCT05685745
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-06
• Study First Posted: 2023-01-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-14
• Primary Completion: 2028-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (37)

University of South Alabama; 🇺🇸 Mobile, Alabama, United States

Vallywise Health Medical Center; 🇺🇸 Phoenix, Arizona, United States

Miller Children's & Women's Hospital; 🇺🇸 Long Beach, California, United States

Children's Hospital, Orange County; 🇺🇸 Orange, California, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States

University of Florida, Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Orlando Health Winnie Palmer Hospital for Women & Babies; 🇺🇸 Orlando, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

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