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出境医 / 临床实验 / Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Congenital Heart Disease
Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Congenital Heart Disease
Study Description
Brief Summary:
The use of neutrophil lymphocyte ratio is useful for the detection of infection status in newborns after surgery
| Condition or disease | Intervention/treatment |
|---|---|
| Sepsis Newborn | Diagnostic Test: Neutrophil to lymphosit ratio |
Detailed Description:
The use of neutrophil lymphocyte ratio is useful for the detection of infection status in newborns after surgery and we compare this with other acute phase reactants
Study Design
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 60 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 1 Month |
| Official Title: | Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Congenital Heart Disease |
| Actual Study Start Date : | January 1, 2015 |
| Actual Primary Completion Date : | December 31, 2018 |
| Actual Study Completion Date : | December 31, 2018 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Neutrophil to Lymphocyte Ratio [ Time Frame: 1 day ]We measure this with complete blood count to calculate the percentage of neutrophil count to the number of lymphocytes
- Neutrophil to Lymphocyte Ratio [ Time Frame: 2 week ]We measure this with complete blood count to calculate the percentage of neutrophil count to the number of lymphocytes
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Study Population
This study was conducted in the NICU of Tepecik Training and Research Hospital, İzmir,
Criteria
Inclusion Criteria:
- newborn to be operated with the diagnosis of congenital heart disease
Exclusion Criteria:
- age older than 1 month not to be operated
Contacts and Locations
No Contacts or Locations Provided
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 17, 2019 | ||||
| First Posted Date | April 22, 2019 | ||||
| Last Update Posted Date | April 22, 2019 | ||||
| Actual Study Start Date | January 1, 2015 | ||||
| Actual Primary Completion Date | December 31, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| 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 | Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Congenital Heart Disease | ||||
| Official Title | Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Congenital Heart Disease | ||||
| Brief Summary | The use of neutrophil lymphocyte ratio is useful for the detection of infection status in newborns after surgery | ||||
| Detailed Description | The use of neutrophil lymphocyte ratio is useful for the detection of infection status in newborns after surgery and we compare this with other acute phase reactants | ||||
| Study Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
||||
| Target Follow-Up Duration | 1 Month | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | This study was conducted in the NICU of Tepecik Training and Research Hospital, İzmir, | ||||
| Condition | Sepsis Newborn | ||||
| Intervention | Diagnostic Test: Neutrophil to lymphosit ratio | ||||
| 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 |
60 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | December 31, 2018 | ||||
| Actual Primary Completion Date | December 31, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03923543 | ||||
| Other Study ID Numbers | (2018/12- 7 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Firat Ergin, Tepecik Training and Research Hospital | ||||
| Study Sponsor | Firat Ergin | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Tepecik Training and Research Hospital | ||||
| Verification Date | April 2019 | ||||
