Clinical trial NCT05685745: Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset
Official title: Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infant, Extremely Premature
Obstetric Labor, Premature
Premature Birth
Intensive Care, Neonatal
Intensive Care Units, Neonatal
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
name: University of Iowa
name: University of Alabama at Birmingham
name: Jichi Medical University
name: Saitama Medical University
First posted: 2023-01-17
Enrollment: 5000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participating hospitals

Brief 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.

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.

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.

Primary outcomes:
measure: 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
timeFrame: Longitudinal database through 1/2028
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Phoenix
country: United States
facility: Vallywise Health Medical Center
state: Arizona
city: Long Beach
country: United States
facility: Miller Children's & Women's Hospital
state: California
city: Orange
country: United States
facility: Children's Hospital, Orange County
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Jacksonville
country: United States
facility: University of Florida, Jacksonville
state: Florida
city: Orlando
country: United States
facility: Orlando Health Winnie Palmer Hospital for Women & Babies
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: The Women's Hospital of Texas
state: Texas
city: San Antonio
country: United States
facility: CHRISTUS Children's Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Children's Hospital
state: Texas
city: San Antonio
country: United States
facility: St. Luke's Baptist Hospital
state: Texas
city: San Antonio
country: United States
facility: North Central Baptist Hospital
state: Texas
city: Richmond
country: United States
facility: Children's Hospital of Richmond
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Surrey
country: Canada
facility: Fraser Health Surrey Memorial Hospital
state: British Columbia
city: Cologne
country: Germany
facility: University of Cologne
city: Shinkawa
country: Japan
facility: Kyorin University Hospital
state: Mitaka
city: Azumino
country: Japan
facility: Nagano Children's Hospital
state: Nagano
city: Izumi
country: Japan
facility: Osaka Women's & Children's Hospital
state: Osaka
city: Kawagoe
country: Japan
facility: Saitama Medical Center, Saitama Medical University
state: Saitama
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Tokyo
country: Japan
facility: National Center for Child Health and Development
city: La Paz
country: Spain
facility: La Paz Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Matthew A Rysavy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.