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NCT05685745 Clinical Trial

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

Premature Birth Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05685745
Other study ID # HSC-MS-22-0578
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date January 1, 2028

Study information
Verified date June 2023
Source The University of Texas Health Science Center, Houston
Contact Matthew A Rysavy, MD, PhD
Phone 713-500-5651
Email Matthew.A.Rysavy@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date January 1, 2028
Est. primary completion date January 1, 2028
Accepts healthy volunteers
Gender All
Age group 0 Years to 1 Year
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Nagano Children's Hospital Azumino Nagano
Japan Osaka Women's & Children's Hospital Izumi Osaka
Japan Saitama Medical Center, Saitama Medical University Kawagoe Saitama
Japan Jichi Medical University Hospital Shimotsuke Tochigi
Japan Kyorin University Hospital Shinkawa Mitaka
Sweden Uppsala University Hospital Uppsala Uppland
United States University of Alabama at Birmingham Birmingham Alabama
United States Nationwide Children's Hospital Columbus Ohio
United States Duke University Durham North Carolina
United States The University of Texas Health Science Center at Houston Houston Texas
United States The Women's Hospital of Texas Houston Texas
United States University of Iowa Iowa City Iowa
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (6)
Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston Jichi Medical University, Nationwide Children's Hospital, Saitama Medical University, University of Alabama at Birmingham, University of Iowa

Countries where clinical trial is conducted

United States,  Japan,  Sweden, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Longitudinal database through 1/2028
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