Premature Birth Clinical Trial
Official title:
Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset
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.
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. |
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 |
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 |
United States, Japan, Sweden,
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
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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