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出境医 / 临床实验 / Livet Skal Leves (A Life to Live)

Livet Skal Leves (A Life to Live)

Study Description
Brief Summary:
The overall objective of this project is to optimize the use of diagnostic methods and follow-up programs in infants with congenital heart defects (CHDs) in order to reduce death and complications

Condition or disease Intervention/treatment
Heart Defects, Congenital Procedure: Heart surgery

Detailed Description:

The project is designed as retrospective cohort study based on nationwide registry data of children born 2004-16. The project group has extensive experience of similar research, and includes representatives from different fields and levels of health care.

The results will provide a solid fundament for improvement of today's clinical practice, including development of knowledge-based routines in neonatal medicine and planning of health care services. Implementation is given particular attention, and will be managed in an interdisciplinary setting. The project will be of major relevance for the patients and their families as well as medical professionals at all levels of health care.

Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: Heart Defects in Infants- Detection, Rescue and Care
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2018
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Mortality [ Time Frame: 0-2 years ]
    All deaths including prenatal termination of pregnancy


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 18, 2019
First Posted Date May 21, 2019
Last Update Posted Date May 22, 2019
Actual Study Start Date October 1, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2019) 		Mortality [ Time Frame: 0-2 years ]
All deaths including prenatal termination of pregnancy
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Livet Skal Leves (A Life to Live)
Official Title Heart Defects in Infants- Detection, Rescue and Care
Brief Summary The overall objective of this project is to optimize the use of diagnostic methods and follow-up programs in infants with congenital heart defects (CHDs) in order to reduce death and complications
Detailed Description

The project is designed as retrospective cohort study based on nationwide registry data of children born 2004-16. The project group has extensive experience of similar research, and includes representatives from different fields and levels of health care.

The results will provide a solid fundament for improvement of today's clinical practice, including development of knowledge-based routines in neonatal medicine and planning of health care services. Implementation is given particular attention, and will be managed in an interdisciplinary setting. The project will be of major relevance for the patients and their families as well as medical professionals at all levels of health care.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population National population
Condition Heart Defects, Congenital
Intervention Procedure: Heart surgery
All invasive procedures
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 20, 2019) 		3000
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2018
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Fetuses with severe CHDs who were identified by antenatal ultrasound screening, and where the pregnancy was terminated
  • Children with severe congenital heart defects born in Norway 2004-18

Exclusion Criteria:

  • Lack of parental consent
Sex/Gender
Sexes Eligible for Study: All
Ages up to 2 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03957512
Other Study ID Numbers REK2010/392
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Henrik Holmstrøm, Oslo University Hospital
Study Sponsor Oslo University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Henrik Holmstrøm, Dr Med Oslo University Hospital/University of Oslo
PRS Account Oslo University Hospital
Verification Date May 2019

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