Prospective Registration of Taiwan Neonatal Network (TNN)

February 15, 2024 updated by: National Taiwan University Hospital
The Taiwan Neonatal Network (TNN) is an organizational structure that unites the neonatal care centers of multiple hospitals and aims to improve the quality of medical care. Countries around the world have successively established their neonatal medical care network systems to improve the quality of their neonatal care. Since the establishment of the TNN system in 2016, after five years of retrospective statistical analysis of medical records, the establishment of the TNN network system and the short-term and mid-term goals have been completed. In order to continue and improve the long-term goals and objectives of the TNN system, to improve the indicators of newborn care in Taiwan and to establish a more complete preterm infant database, it is planned to change to prospective collection, and the future preterm infant data will be registered in the TNN system. And further establish a database of various preterm infant care outcome indicators and risk factors. After statistical correction, the various preterm infant care outcome indicators among different hospitals can be regarded as the benchmark learning objects of other hospitals, and based on empirical medicine. Medical quality improvement methods have improved the quality of medical care for premature infants in Taiwan.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Neonatal intensive care medicine has developed very rapidly recently, especially with the help of more advanced technology and novel treatment methods, it has achieved very good results in neonatal medicine. Despite the rapid development of neonatal intensive care medicine, death cannot be avoided with continuously updated medical equipment and treatment methods. This phenomenon is even more pronounced in the medical field of premature infants. In addition, some data can be found in different NICU settings, that is, there will be different significant results. In addition, the cost of neonatal care and medical care is extremely high, and it costs at least 10,000 yuan per day in the NICU. Since the outcome of neonatal care will be affected by the quality of medical care, and the cost of neonatal care is also high, the most important key point in neonatal care is the establishment of novel treatment methods and equipment selection. is effective and highly effective.The Taiwan Neonatal Network System (Taiwan Neonatal Network) is an organizational structure that unites the neonatal care centers of several hospitals and aims to improve the quality of their medical care. Countries around the world have successively established their neonatal medical care network systems to improve the quality of their neonatal care. Taiwan has an average of nearly 200,000 newborns every year, of which 8% to 10% are premature babies, so there are nearly 20,000 premature babies every year. In recent years, its survival rate has been significantly improved. However, premature infants are a high-risk group for complications. Among them, premature infants with a birth weight of less than 1500 grams have a higher mortality and morbidity rate. Therefore, this project is based on Improve the care of premature infants and reduce mortality and sequelae of premature infants.To achieve this goal, the mission is improving the quality and safety of medical care for newborn infants through a multidisciplinary approach of coordinated program of research, education, and quality improvement projects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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,

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Taiwan Society of Neonatology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Po-Nien Tsao, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2050

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202110099RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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