Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Infant, Extremely Premature, Obstetric Labor, Premature, Premature Birth, Intensive Care, Neonatal. Basic parameters: 0 years — 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, Czechia, Germany +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome 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 manner [Time frame: Longitudinal database through 1/2028]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 43 centers
- University of Alabama at Birmingham — Birmingham
- University of South Alabama — Mobile
- Vallywise Health Medical Center — Phoenix
- Loma Linda University Children's Hospital — Loma Linda
- Miller Children's & Women's Hospital — Long Beach
- Children's Hospital, Orange County — Orange
- University of California, San Diego — San Diego
- Joe DiMaggio Children's Hospital — Hollywood
- … and 35 more centers
Japan · 6 centers
- Kyorin University Hospital — Shinkawa
- Nagano Children's Hospital — Azumino
- Osaka Women's & Children's Hospital — Izumi
- Saitama Medical Center, Saitama Medical University — Kawagoe
- Jichi Medical University Hospital — Shimotsuke
- National Center for Child Health and Development — Tokyo
Australia · 4 centers
- Mater Mother's Hospital — South Brisbane
- Mercy Hospital for Women — Heidelberg
- The Royal Women's Hospital — Parkville
- King Edward Memorial Hospital — Perth
Canada · 2 centers
- Fraser Health Surrey Memorial Hospital — Surrey
- Sunnybrook Health Sciences Centre — Toronto
Czechia · 1 center
- General Faculty Hospital, Prague — Prague
Germany · 1 center
- University of Cologne — Cologne
Spain · 1 center
- La Paz Hospital — La Paz
Sweden · 1 center
- Uppsala University Hospital — Uppsala
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. PMID 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. PMID 33691163
Identifiers
NCT: NCT05685745 · HSC-MS-22-0578