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MINI Minimum Dataset for Extremely Premature Infants

This study, called the Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset, is collecting information about extremely premature infants. Researchers are gathering details on deliveries and infants admitted to intensive care who were born between 22 and 23 weeks of pregnancy. The goal is to create a registry of characteristics and outcomes for these babies. This information will help hospitals improve care and understand how different treatments affect these infants. You or your infant might be included if your baby was born at 22 weeks 0 days to 23 weeks 6 days gestation, either at a participating hospital or admitted to their Neonatal Intensive Care Unit (NICU). This is an observational study, meaning no new treatments are being tested; instead, existing care and outcomes are being recorded.

Study design
This is an observational study, not testing any specific intervention. It aims to enroll about 5000 participants, collecting data on mothers and infants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Data will be collected into a longitudinal database through January 2028.

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NCT05685745

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

Recruiting
Not specifiedAges 0–1Observational
The University of Texas Health Science Center, Houston
~5,000 participants
Updated 2026-07-06 on ClinicalTrials.gov

At a glance

Recruiting sites
59 of 59 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Longitudinal database through 1/2028

Conditions

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

Explore related trials

Preterm Birth

Where it's being run

59 sites across 34 states
Texas8
Florida5
California4
Georgia3
Massachusetts3
Alabama2
New York2
North Carolina2

Study leadership

  • Matthew A Rysavy, MD, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Matthew A Rysavy, MD, PhD
[email protected]
713-500-5651
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Eligibility criteria

Inclusion

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.

What this trial measures

  • 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 mannerLongitudinal database through 1/2028