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NCT Number: NCT05685745

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

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.

Recruiting

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Key information

Conditions

Infant, Extremely Premature Female Urogenital Diseases and Pregnancy Complications Intensive Care Units, Neonatal Intensive Care, Neonatal Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

0 year–1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mater Mother's Hospital, South Brisbane, Queensland, Australia

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew A Rysavy, MD, PhD

CONTACT

[email protected]

713-500-5651

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Jichi Medical University
  • Nationwide Children's Hospital
  • Saitama Medical University
  • University of Alabama at Birmingham
  • University of Iowa

Registry information

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Jan 17, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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