- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05294276
Prospective Registration of Taiwan Neonatal Network (TNN)
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Po-Nien Tsao
- Phone Number: 71013 02-23123456
- Email: tsaopn@gmail.com
Study Locations
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Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Po-Nien Tsao, Prof
- Phone Number: 71604 02-23123456
- Email: yinlee1126@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Any newborn with a birth weight between 401 grams and 1500 grams or a number of weeks of birth between 22 weeks plus 0 days to 29 weeks plus 6 days of live birth, if one of the above two conditions is met, it meets the preliminary acceptance criteria. Another case meets any of the following conditions:
i. Newborn born in this hospital and admitted to the hospital or ii. Newborn born in this hospital but died in the delivery room (or anywhere in this hospital) before being transferred to the intensive care unit or iii. Newborn born in the outer hospital and transferred to this hospital within 28 days of birth (the newborn has not been discharged and returned home before being transferred from the previous hospital to this hospital).
Exclusion Criteria:
Nil
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of neonatal caring: Newborn Information Registration Form
Time Frame: through study completion, an average of 1 year
|
Newborn Information Registration Form to measure all the characteristic data, morbidities and treatments, mortality for the enrolled preterm infants
|
through study completion, an average of 1 year
|
|
Quality of neonatal caring: CLD assessment
Time Frame: through study completion, an average of 1 year
|
Chronic Lung Disease Assessment aim to reduce the incidence of CLD
|
through study completion, an average of 1 year
|
|
Quality of neonatal caring: EUGR assessment
Time Frame: through study completion, an average of 1 year
|
ExtraUterine Growth Restriction assessment aim to reduce the incidence of EUGR
|
through study completion, an average of 1 year
|
|
Quality of neonatal caring: Hypothermia Registration Form
Time Frame: through study completion, an average of 1 year
|
Hypothermia Registration Form aim to prevent hypothermia after birth
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Po-Nien Tsao, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 202110099RINA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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