ClinicalTrials.gg
RecruitingNCT05685745Updated Jul 6, 2026

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

An observational study in Infant, Extremely Premature, Obstetric Labor, Premature and Premature Birth, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 59 sites in 8 countries. Open to participants aged 0 Years to 1 Year. Per ClinicalTrials.gov, last updated 2026-07-06.

Primary conditionPremature BirthRegistry: Obstetric Labor, PrematureReclassifiedWhy we changed it
Registry
Obstetric Labor, Premature — the first condition term the registry derived for this study.
ClinicalTrials.gg
Premature Birth
Why
  1. The study's listed conditions name Premature Birth, a narrower term within Obstetric Labor, Premature.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by The University of Texas Health Science Center, Houston · Observational

From the registry’s dates

  • Started Jan 2019; still recruiting 7 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
0 Years to 1 Year
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Browse trials for

03

In context

Premature Birth Reclassified

2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 120 across 806 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.

Compared within Premature Birth, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Obstetric Labor, Premature. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
0 Years to 1 Year
Sexes eligible
All
Sampling method
Probability sample

Study population

Participating hospitals

Eligibility 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

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

07

Study locations

59 of 59 sites recruiting
08

References and documents

Publications

  • Rysavy M, Nakamura T, Mehler K, Agren J, McNamara P, Backes C; Tiny Baby Collaborative. Use of 2.0-mm endotracheal tubes for periviable infants. J Perinatol. 2022 Sep;42(9):1275-1276. doi: 10.1038/s41372-022-01323-7. Epub 2022 Jan 26. No abstract available. PubMed 35082430 ↗
  • Rysavy MA, Mehler K, Oberthur A, Agren J, Kusuda S, McNamara PJ, Giesinger RE, Kribs A, Normann E, Carlson SJ, Klein JM, Backes CH, Bell EF. An Immature Science: Intensive Care for Infants Born at </=23 Weeks of Gestation. J Pediatr. 2021 Jun;233:16-25.e1. doi: 10.1016/j.jpeds.2021.03.006. Epub 2021 Mar 7. No abstract available. PubMed 33691163 ↗

Related links

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2019 (actual). Primary completion is estimated for Jan 2030, 132 months after the start.

Of 372 non-industry observational studies under Premature Birth, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 63. This study's planned 132 months is above that.

Counting every sponsor, half of 387 studies reached it within 35 months; a quarter within 18 and three quarters within 61.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 6, 2023
First posted
Jan 17, 2023
StartActual
Jan 1, 2019
Primary completionEst.
Jan 1, 2030
CompletionEst.
Jan 1, 2030
Last update
Jul 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05685745
Collaborators
Nationwide Children's Hospital, University of Iowa, University of Alabama at Birmingham, Jichi Medical University, Saitama Medical University
Responsible party
Matthew Rysavy (Associate Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Jan 17, 2023
Start date
Jan 1, 2019
Primary completion
Jan 1, 2030 (estimated)
Completion
Jan 1, 2030 (estimated)
Last update
Jul 6, 2026

Study contacts

Matthew A Rysavy, MD, PhD
Contact
Matthew.A.Rysavy@uth.tmc.edu
713-500-5651
Matthew A Rysavy, MD, PhD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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