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出境医 / 临床实验 / Evaluation of Enteral Nutrition in Critically Ill Children
Evaluation of Enteral Nutrition in Critically Ill Children
Study Description
Brief Summary:
The aim of this study was to evaluate the effect of calorie and enteral feeding timing on survival in critically ill children receiving inotropic, vasopressor and inodilatory supplements.
| Condition or disease |
|---|
| Critical Illness Enteral Feeding Intolerance |
Detailed Description:
The aim of this study was to evaluate the effect of calorie and enteral feeding timing on survival in critically ill children receiving inotropic, vasopressor and inodilatory supplements. Early enteral nutrition will be initiated within the first 24 hours of hospitalization in critically ill children who have inotropic vasopressor and inodilator support without any problems and contraindications in gastrointestinal system functions. The energy requirement of the intubated patients will be measured by indirect calorie meter method. Schofield method will be used to calculate the daily energy needs of extubated patients. 30% of the targeted energy in the first 48 hours of hospitalization and 80% of the targeted energy in the first week will be achieved by enteral nutrition.Nutritional solutions with a concentrated formula of 1 / 1.5 will be given to patients with cardiac pulmonary or renal disease requiring fluid restriction.Patients will be followed up for vomiting, diarrhea, abdominal distention, feeding intolerance, gastric residues and gastrointestinal bleeding. If these findings develop, the patient's nutrition will be interrupted according to the clinician's assessment and enteral nutrition will be re-fed as soon as possible.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 20 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Evaluation of Enteral Nutrition in Critically Ill Children Receiving Inotropic Support in Pediatric Intensive Care Unit |
| Actual Study Start Date : | June 1, 2019 |
| Estimated Primary Completion Date : | January 1, 2020 |
| Estimated Study Completion Date : | June 1, 2020 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 28-d mortality [ Time Frame: 28 days ]To evaluate the effect of enteral feeding timing on survival
Secondary Outcome Measures :
- Lactate [ Time Frame: During inotropic treatment ]To observe safe lactate levels suitable for enteral nutrition. Lactate levels will be measure 4 times in a day.
- Vasoactive inotrope score [ Time Frame: During inotropic treatment ]To observe maximum vasoactive inotrope score suitable for enteral nutrition. Maximum VIS will be recorded.
Eligibility Criteria
| Ages Eligible for Study: | 1 Month to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Critically ill children who have inotropic, vasopressor or inodilatory supplements without any problems and contraindications in gastrointestinal system functions
Criteria
Inclusion Criteria:
- Children with normal gastrointestinal system function
- Children receiving inotropic, vasopressor or inodilatory support
Exclusion Criteria:
- Children with gastrointestinal system dysfunction
- Children with enteral nutrition contraindicated
- Children with metabolic disease with special nutrition
Contacts and Locations
Contacts
| Contact: Ahmet Yöntem | +905075097709 | drayontem@gmail.com |
Locations
| Turkey | |
| Cukurova University, Division of Pediatric Intensive Care Unit | Recruiting |
| Adana, Turkey, 01380 | |
| Contact: Dinçer Yildizdaş, Professor +903223386060 ext 3377 dyildizdas@gmail.com | |
Sponsors and Collaborators
Cukurova University
Investigators
| Study Chair: | Dincer Yildizdaş, Professor | Cukurova University Medicine Faculty |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | July 8, 2019 | ||||
| First Posted Date | July 10, 2019 | ||||
| Last Update Posted Date | July 12, 2019 | ||||
| Actual Study Start Date | June 1, 2019 | ||||
| Estimated Primary Completion Date | January 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
28-d mortality [ Time Frame: 28 days ] To evaluate the effect of enteral feeding timing on survival
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| Original Primary Outcome Measures |
To evaluate the effect of enteral feeding timing on survival [ Time Frame: 3 months ] To evaluate the effect of enteral feeding timing on survival
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| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Evaluation of Enteral Nutrition in Critically Ill Children | ||||
| Official Title | Evaluation of Enteral Nutrition in Critically Ill Children Receiving Inotropic Support in Pediatric Intensive Care Unit | ||||
| Brief Summary | The aim of this study was to evaluate the effect of calorie and enteral feeding timing on survival in critically ill children receiving inotropic, vasopressor and inodilatory supplements. | ||||
| Detailed Description | The aim of this study was to evaluate the effect of calorie and enteral feeding timing on survival in critically ill children receiving inotropic, vasopressor and inodilatory supplements. Early enteral nutrition will be initiated within the first 24 hours of hospitalization in critically ill children who have inotropic vasopressor and inodilator support without any problems and contraindications in gastrointestinal system functions. The energy requirement of the intubated patients will be measured by indirect calorie meter method. Schofield method will be used to calculate the daily energy needs of extubated patients. 30% of the targeted energy in the first 48 hours of hospitalization and 80% of the targeted energy in the first week will be achieved by enteral nutrition.Nutritional solutions with a concentrated formula of 1 / 1.5 will be given to patients with cardiac pulmonary or renal disease requiring fluid restriction.Patients will be followed up for vomiting, diarrhea, abdominal distention, feeding intolerance, gastric residues and gastrointestinal bleeding. If these findings develop, the patient's nutrition will be interrupted according to the clinician's assessment and enteral nutrition will be re-fed as soon as possible. | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Critically ill children who have inotropic, vasopressor or inodilatory supplements without any problems and contraindications in gastrointestinal system functions | ||||
| Condition |
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
20 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | June 1, 2020 | ||||
| Estimated Primary Completion Date | January 1, 2020 (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 | 1 Month to 18 Years (Child, Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | Turkey | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04013893 | ||||
| Other Study ID Numbers | CUTF-GOKAEK-86 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Ahmet Yontem, Cukurova University | ||||
| Study Sponsor | Cukurova University | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Cukurova University | ||||
| Verification Date | July 2019 | ||||
