Home › Trials › NCT05685745

Registry of outcomes and practices for extremely premature infants

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

Observational The University of Texas Health Science Center, Houston · NCT05685745

This study is trying to gather information about the health and care of extremely premature infants born at 22-23 weeks to help improve their treatment and outcomes.

Quick facts

Study typeObservational
Enrollment5000 (estimated)
Ages0 Years to 1 Year
SexAll
SponsorThe University of Texas Health Science Center, Houston Academic / other
Locations51 sites (Birmingham, Alabama and 50 other locations)
Trial IDNCT05685745 on ClinicalTrials.gov

What this trial studies

The Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset aims to create a comprehensive registry that details the outcomes and practices for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation across participating hospitals. This observational study collects baseline data on mothers and infants, including demographics, health status, medical interventions, and clinical outcomes. The collected data will be utilized for quality improvement reporting, evaluating associations between characteristics and outcomes, and tracking trends in neonatal care.

Who should consider this trial

Good fit: Ideal candidates for this study include all infants born at 22-23 weeks' gestation and their mothers, regardless of the outcome.

Not a fit: Patients born before 22 weeks' gestation may not receive direct benefits from this study.

Why it matters

Potential benefit: If successful, this registry could enhance the understanding of care practices and outcomes for extremely premature infants, leading to improved treatment protocols.

How similar studies have performed: Other studies have successfully utilized similar registry approaches to improve neonatal care, indicating potential for this study's success.

Eligibility criteria

Show full inclusion / 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.

Where this trial is running

Birmingham, Alabama and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Infant, Extremely PrematureObstetric Labor, PrematurePremature BirthIntensive Care, NeonatalIntensive Care Units, Neonatal
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.