Enteral NutritionERTENIFABPICUNCT02598375
Evaluation of Status of Early Reached Target Enteral Nutrition and IFABP as Biomarker of Feeding Intolerance in Critically Ill Children
An observational study of Enteral Nutrition and Feeding Intolerance, run by Gazi University at 1 site in Germany.
Trial summary
Stage 1 - Evaluation of Status of Early Reached Target Enteral Nutrition in critically ill children in the PICU (ERTEN in PICU). In critically ill children, there is no data on the factors influenced the enteral nutrition and feeding intolerance.The investigators aim to reach these goals in our study To initiate the… Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Enteral Nutrition, Feeding Intolerance, Intestinal Fatty Acid Binding Protein
- What is being tested?
- Feeding intolerance
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Dec 2017
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: The critically ill children in PICU who stay at least for 4 days
Who may be able to join
- critically iil children who stayed in PICU at least for 4 days
- having informed consent from the parents of patients
Who cannot join
- children with primary gastrointestinal problems ( ulcerative colitis ,crohn ,acute gastrointestinal bleeding )
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Bonn University Faculty of Medicine
Bonn, 53127
Soyhan Bagci, 1, 0049 151 582 33 102, soyhan.bagci@ukb.uni-bonn.de
Elif Keleş, 2, 00905366741270, elifkeles.dr@gmail.com
About this study
Official title: Stage 1Evaluation of Status of Early Reached Target Enteral Nutrition in Critically Ill Children in the PICU (ERTEN in PICU) Stage 2 IFABP as Biomarker of Feeding Intolerance in Critically Ill Children in the PICU(IFABP in PICU)
Stage 1 - Evaluation of Status of Early Reached Target Enteral Nutrition in critically ill children in the PICU (ERTEN in PICU).
In critically ill children, there is no data on the factors influenced the enteral nutrition and feeding intolerance.The investigators aim to reach these goals in our study
Read more
- To initiate the enteral feeding in pediatric intensive care units or not
- To demonstrate the reasons whether early enteral feeding is initiated or not
- To determine the incidence of feeding intolerance
- To identify the situations such as analgesia ,sedation, catecholamines or individual preferences of the medical staff which lead to delay or interruption in enteral feeding in pediatric intensive care units
- To investigate the relation between the successful enteral feeding and mortality , morbidity du to the sepsis , septic shock and multiorgan failure
Stage 2 - IFABP as biomarker of feeding intolerance in critically ill children in the PICU (IFABP in PICU)
Critically ill children are at increased risk for intestinal injury, gastrointestinal dysfunction and feeding intolerance, which are associated with delayed recovery and increased morbidity and mortality during their course in the pediatric intensive care unit. In critically ill children, there is little data on the factors influenced the enteral nutrition. We hypothesise that IFABP might be used as a biomarker which shows that the early intestinal damage due to these medications.
Aim There is no information which shows that the role of the intestinal microcirculation problems and mucosal integrity on feeding intolerance in pediatric intensive care unit.We aim to reach these goals in our study
- To show the value of IFABP regarding the identifying feeding intolerance and early detection of enteral feeding intolerance
- To show the relation between the IFABP concentration and enteral feeding intolerance
- To show the relation between the mechanical ventilation settings , sedation , inotropic medications doses and IFABP concentration and feeding intolerance
- To show the relation between IFABP concentrations and mortality and morbidity due to the sepsis , septic shock and multi system organ failure
Stage 1 (ERTEN in PICU) was completed . In many patients, initiation of feeding seems to be delayed without an evidence-based reason. ERTEN was achieved in 43 (25.3%) of 95 patients within 48 h after PICU admission. Patients with Early Initiation of Feeding were statistically significant more likely to have ERTEN. ERTEN was independent significant prognostic factors for survival (p<0.001), with reached target enteral caloric intake on day 2 indicating improved survival.
Read the detailed description
Stage 1 - Evaluation of Status of Early Reached Target Enteral Nutrition in critically ill children in the PICU (ERTEN in PICU) In critically ill children, there is no data on the factors influenced the enteral nutrition and feeding intolerance.We aim to reach these goals in our study
- To initiate the enteral feeding in pediatric intensive care units or not
- To demonstrate the reasons whether early enteral feeding is initiated or not
- To determine the incidence of feeding intolerance
- To identify the situations such as analgesia ,sedation, catecholamines or individual preferences of the medical staff which lead to delay or interruption in enteral feeding in pediatric intensive care units
- To investigate the relation between the successful enteral feeding and mortality , morbidity du to the sepsis , septic shock and multiorgan failure
Stage 2 - IFABP as biomarker of feeding intolerance in critically ill children in the PICU (IFABP in PICU) Critically ill children are at increased risk for intestinal injury, gastrointestinal dysfunction and feeding intolerance, which are associated with delayed recovery and increased morbidity and mortality during their course in the pediatric intensive care unit. In critically ill children, there is little data on the factors influenced the enteral nutrition. Feeding intolerance in the critically ill children may be due to in part to alterations in gastrointestinal motility secondary to the underlying disease process or administrations of medication.It is also known the role of hyperglycemia, caloric density of enteral nutrition and gastrointestinal feedback mechanism, and routine intensive care management such as sedation, analgesia and catecholamines on the feeding intolerance in critically ill children. We hypothesise that IFABP might be used as a biomarker which shows that the early intestinal damage due to these medications.
Aim There is no information which shows that the role of the intestinal microcirculation problems and mucosal integrity on feeding intolerance in pediatric intensive care unit.We aim to reach these goals in our study
- To show the value of IFABP regarding the identifying feeding intolerance and early detection of enteral feeding intolerance
- To show the relation between the IFABP concentration and enteral feeding intolerance
- To show the relation between the mechanical ventilation settings , sedation , inotrope medications doses and IFABP concentration and feeding intolerance
- To show the relation between IFABP concentrations and mortality and morbidity due to the sepsis , septic shock and multi system organ failure We aim to reach theses goals in near future
- To find the common definitions regarding enteral feeding intolerance in order to identify and recognize the clinical problems in advance for the medical staff in Turkey
- To recognize the patients who have the possibility the enteral feeding problems with the help of the clinical and biochemical biomarkers (IFABP)
- To establish the early enteral feeding protocols in order to provide widespread using in pediatric intensive care units.
- With the help of these acquirement in the pediatrics intensive care unit to achieve the reduce the length of hospital stay , morbidity and mortality
The critically ill children who are hospitalized at least for 24 hours in PICU are eligible for the Stage 1ERTEN IN PICU
The critically ill children who are hospitalized at least for 4 days in PICU are eligible for the Stage2 IFABP IN PICU
- Being tested
- Feeding intolerance
- Keywords
- Early reached target enteral nutrition in PICU feeding intolerance IFABP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding intoleranceOther
In this study ; it is aimed to show the value of IFABP regarding the identifying the feeding intolerance and early detection of enteral feeding intolerance
| Study group | Role | What they receive |
|---|---|---|
| Children with feeding intolerance | Critically ill children having with respiratory or catecholamine support in PICU have the feeding intolerance at least for12 hours or more. Receives: Other: Feeding intolerance | |
| Children without feeding intolerance | Critically ill children having with respiratory or catecholamine support in PICU have not the feeding intolerance signs at least for 12 hours or less Receives: Other: Feeding intolerance |
What is being measured
The primary outcome is the main question the study is designed to answer.
IFABP
IFABP level in urine will be evaluated in critically iil children in order to understand feeding intolerance and /or bacterial translocation
Measured: 10 days
Secondary outcomes (3)
Zonulin
zonulin level in blood will be evaluated in critically ill children in order to show bacterial translocation and intestinal barrier problems
Measured: 10 days
8-hydroxydeoxyguanosine
8-hydroxydeoxyguanosine level in urine will be evaluated in critically ill children in order to show bacterial translocation and intestinal barrier problems
Measured: 10 days
Claudin-3
Claudin-3 level in urine will be evaluated in critically ill children in order to show bacterial translocation and intestinal barrier problems
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Cukurova University, Children's Medical Hospital, University of Bonn, Germany, Eskisehir Osmangazi University, Akdeniz University, TC Erciyes University, Hacettepe University, Dokuz Eylul University, Tepecik Training and Research Hospital, Marmara University, Ankara University, Zonguldak Bulent Ecevit University, Istanbul University, Istanbul Medipol University Hospital, Sisli Hamidiye Etfal Training and Research Hospital, Acibadem University
- Responsible party
- Principal investigator, Elif Keleş,MD, Gazi University
- Investigators
- Dincer Yildizdas, 3, Study chair, Çukurova University Faculty of MedicineSoyhan Bagcı, 2, Study director, Bonn University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598375
- Sponsor's protocol ID
- ERTEN-IFABP IN PICU
- Acronym
- ERTENIFABPICU
- Status last verified
- Dec 2016
- First submitted
- 4 Nov 2015
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: It is concluded the first phase of ERTEN-IFABP IN PICU.95 patients date were evaluated and the statistically significant results were obtained in the first observational phase of the study We conduct the second phase of our study.
Publications
Mehta NM, McAleer D, Hamilton S, Naples E, Leavitt K, Mitchell P, Duggan C. Challenges to optimal enteral nutrition in a multidisciplinary pediatric intensive care unit. JPEN J Parenter Enteral Nutr. 2010 Jan-Feb;34(1):38-45. doi: 10.1177/0148607109348065. Epub 2009 Nov 10.
PubMed 19903872Lopez-Herce J. Gastrointestinal complications in critically ill patients: what differs between adults and children? Curr Opin Clin Nutr Metab Care. 2009 Mar;12(2):180-5. doi: 10.1097/MCO.0b013e3283218285.
PubMed 19202390Pathan N, Burmester M, Adamovic T, Berk M, Ng KW, Betts H, Macrae D, Waddell S, Paul-Clark M, Nuamah R, Mein C, Levin M, Montana G, Mitchell JA. Intestinal injury and endotoxemia in children undergoing surgery for congenital heart disease. Am J Respir Crit Care Med. 2011 Dec 1;184(11):1261-9. doi: 10.1164/rccm.201104-0715OC. Epub 2011 Aug 25.
PubMed 21868501Mehta NM, Bechard LJ, Cahill N, Wang M, Day A, Duggan CP, Heyland DK. Nutritional practices and their relationship to clinical outcomes in critically ill children--an international multicenter cohort study*. Crit Care Med. 2012 Jul;40(7):2204-11. doi: 10.1097/CCM.0b013e31824e18a8.
PubMed 22564954Mehta NM, Compher C; A.S.P.E.N. Board of Directors. A.S.P.E.N. Clinical Guidelines: nutrition support of the critically ill child. JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):260-76. doi: 10.1177/0148607109333114. No abstract available.
PubMed 19398612Chellis MJ, Sanders SV, Webster H, Dean JM, Jackson D. Early enteral feeding in the pediatric intensive care unit. JPEN J Parenter Enteral Nutr. 1996 Jan-Feb;20(1):71-3. doi: 10.1177/014860719602000171.
PubMed 8788267Mikhailov TA, Kuhn EM, Manzi J, Christensen M, Collins M, Brown AM, Dechert R, Scanlon MC, Wakeham MK, Goday PS. Early enteral nutrition is associated with lower mortality in critically ill children. JPEN J Parenter Enteral Nutr. 2014 May;38(4):459-66. doi: 10.1177/0148607113517903. Epub 2014 Jan 8.
PubMed 24403379Aydemir C, Dilli D, Oguz SS, Ulu HO, Uras N, Erdeve O, Dilmen U. Serum intestinal fatty acid binding protein level for early diagnosis and prediction of severity of necrotizing enterocolitis. Early Hum Dev. 2011 Oct;87(10):659-61. doi: 10.1016/j.earlhumdev.2011.05.004. Epub 2011 Jun 8.
PubMed 21641735Reisinger KW, Van der Zee DC, Brouwers HA, Kramer BW, van Heurn LW, Buurman WA, Derikx JP. Noninvasive measurement of fecal calprotectin and serum amyloid A combined with intestinal fatty acid-binding protein in necrotizing enterocolitis. J Pediatr Surg. 2012 Sep;47(9):1640-5. doi: 10.1016/j.jpedsurg.2012.02.027.
PubMed 22974599Thuijls G, van Wijck K, Grootjans J, Derikx JP, van Bijnen AA, Heineman E, Dejong CH, Buurman WA, Poeze M. Early diagnosis of intestinal ischemia using urinary and plasma fatty acid binding proteins. Ann Surg. 2011 Feb;253(2):303-8. doi: 10.1097/SLA.0b013e318207a767.
PubMed 21245670van Haren FM, Pickkers P, Foudraine N, Heemskerk S, Sleigh J, van der Hoeven JG. The effects of methylene blue infusion on gastric tonometry and intestinal fatty acid binding protein levels in septic shock patients. J Crit Care. 2010 Jun;25(2):358.e1-7. doi: 10.1016/j.jcrc.2010.02.008. Epub 2010 Apr 8.
PubMed 20381302Piton G, Belon F, Cypriani B, Regnard J, Puyraveau M, Manzon C, Navellou JC, Capellier G. Enterocyte damage in critically ill patients is associated with shock condition and 28-day mortality. Crit Care Med. 2013 Sep;41(9):2169-76. doi: 10.1097/CCM.0b013e31828c26b5.
PubMed 23782971
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stage 1Evaluation of Status of Early Reached Target Enteral Nutrition in Critically Ill Children in the PICU (ERTEN in PICU) Stage 2 IFABP as Biomarker of Feeding Intolerance in Critically Ill Children in the PICU(IFABP in PICU)
- ClinicalTrials.gov ID
- NCT02598375
- Acronym / sponsor ID
- ERTENIFABPICU / ERTEN-IFABP IN PICU
- Keywords
- Early reached target enteral nutrition in PICU feeding intolerance IFABP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- Cukurova University, Children's Medical Hospital, University of Bonn, Germany, Eskisehir Osmangazi University, Akdeniz University, TC Erciyes University, Hacettepe University, Dokuz Eylul University, Tepecik Training and Research Hospital, Marmara University, Ankara University, Zonguldak Bulent Ecevit University, Istanbul University, Istanbul Medipol University Hospital, Sisli Hamidiye Etfal Training and Research Hospital, Acibadem University
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stage 1 - Evaluation of Status of Early Reached Target Enteral Nutrition in critically ill children in the PICU (ERTEN in PICU).
In critically ill children, there is no data on the factors influenced the enteral nutrition and feeding intolerance.The investigators aim to reach these goals in our study
- To initiate the enteral feeding in pediatric intensive care units or not
- To demonstrate the reasons whether early enteral feeding is initiated or not
- To determine the incidence of feeding intolerance
- To identify the situations such as analgesia ,sedation, catecholamines or individual preferences of the medical staff which lead to delay or interruption in enteral feeding in pediatric intensive care units
- To investigate the relation between the successful enteral feeding and mortality , morbidity du to the sepsis , septic shock and multiorgan failure
Stage 2 - IFABP as biomarker of feeding intolerance in critically ill children in the PICU (IFABP in PICU)
Critically ill children are at increased risk for intestinal injury, gastrointestinal dysfunction and feeding intolerance, which are associated with delayed recovery and increased morbidity and mortality during their course in the pediatric intensive care unit. In critically ill children, there is little data on the factors influenced the enteral nutrition. We hypothesise that IFABP might be used as a biomarker which shows that the early intestinal damage due to these medications.
Aim There is no information which shows that the role of the intestinal microcirculation problems and mucosal integrity on feeding intolerance in pediatric intensive care unit.We aim to reach these goals in our study
- To show the value of IFABP regarding the identifying feeding intolerance and early detection of enteral feeding intolerance
- To show the relation between the IFABP concentration and enteral feeding intolerance
- To show the relation between the mechanical ventilation settings , sedation , inotropic medications doses and IFABP concentration and feeding intolerance
- To show the relation between IFABP concentrations and mortality and morbidity due to the sepsis , septic shock and multi system organ failure
Stage 1 (ERTEN in PICU) was completed . In many patients, initiation of feeding seems to be delayed without an evidence-based reason. ERTEN was achieved in 43 (25.3%) of 95 patients within 48 h after PICU admission. Patients with Early Initiation of Feeding were statistically significant more likely to have ERTEN. ERTEN was independent significant prognostic factors for survival (p<0.001), with reached target enteral caloric intake on day 2 indicating improved survival.
Detailed description
Stage 1 - Evaluation of Status of Early Reached Target Enteral Nutrition in critically ill children in the PICU (ERTEN in PICU) In critically ill children, there is no data on the factors influenced the enteral nutrition and feeding intolerance.We aim to reach these goals in our study
- To initiate the enteral feeding in pediatric intensive care units or not
- To demonstrate the reasons whether early enteral feeding is initiated or not
- To determine the incidence of feeding intolerance
- To identify the situations such as analgesia ,sedation, catecholamines or individual preferences of the medical staff which lead to delay or interruption in enteral feeding in pediatric intensive care units
- To investigate the relation between the successful enteral feeding and mortality , morbidity du to the sepsis , septic shock and multiorgan failure
Stage 2 - IFABP as biomarker of feeding intolerance in critically ill children in the PICU (IFABP in PICU) Critically ill children are at increased risk for intestinal injury, gastrointestinal dysfunction and feeding intolerance, which are associated with delayed recovery and increased morbidity and mortality during their course in the pediatric intensive care unit. In critically ill children, there is little data on the factors influenced the enteral nutrition. Feeding intolerance in the critically ill children may be due to in part to alterations in gastrointestinal motility secondary to the underlying disease process or administrations of medication.It is also known the role of hyperglycemia, caloric density of enteral nutrition and gastrointestinal feedback mechanism, and routine intensive care management such as sedation, analgesia and catecholamines on the feeding intolerance in critically ill children. We hypothesise that IFABP might be used as a biomarker which shows that the early intestinal damage due to these medications.
Aim There is no information which shows that the role of the intestinal microcirculation problems and mucosal integrity on feeding intolerance in pediatric intensive care unit.We aim to reach these goals in our study
- To show the value of IFABP regarding the identifying feeding intolerance and early detection of enteral feeding intolerance
- To show the relation between the IFABP concentration and enteral feeding intolerance
- To show the relation between the mechanical ventilation settings , sedation , inotrope medications doses and IFABP concentration and feeding intolerance
- To show the relation between IFABP concentrations and mortality and morbidity due to the sepsis , septic shock and multi system organ failure We aim to reach theses goals in near future
- To find the common definitions regarding enteral feeding intolerance in order to identify and recognize the clinical problems in advance for the medical staff in Turkey
- To recognize the patients who have the possibility the enteral feeding problems with the help of the clinical and biochemical biomarkers (IFABP)
- To establish the early enteral feeding protocols in order to provide widespread using in pediatric intensive care units.
- With the help of these acquirement in the pediatrics intensive care unit to achieve the reduce the length of hospital stay , morbidity and mortality
The critically ill children who are hospitalized at least for 24 hours in PICU are eligible for the Stage 1ERTEN IN PICU
The critically ill children who are hospitalized at least for 4 days in PICU are eligible for the Stage2 IFABP IN PICU
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with feeding intolerance | – | Other: Feeding intoleranceCritically ill children having with respiratory or catecholamine support in PICU have the feeding intolerance at least for12 hours or more. |
| Children without feeding intolerance | – | Other: Feeding intoleranceCritically ill children having with respiratory or catecholamine support in PICU have not the feeding intolerance signs at least for 12 hours or less |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The critically ill children in PICU who stay at least for 4 days
Key inclusion criteria (2 listed)
- critically iil children who stayed in PICU at least for 4 days
- having informed consent from the parents of patients
Key exclusion criteria (1 listed)
- children with primary gastrointestinal problems ( ulcerative colitis ,crohn ,acute gastrointestinal bleeding )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feeding intoleranceIn this study ; it is aimed to show the value of IFABP regarding the identifying the feeding intolerance and early detection of enteral feeding intolerance | Other | Children with feeding intolerance, Children without feeding intolerance |
Primary outcome
IFABP
Time frame: 10 days
IFABP level in urine will be evaluated in critically iil children in order to understand feeding intolerance and /or bacterial translocation
3 secondary outcomes
Zonulin
Time frame: 10 days
8-hydroxydeoxyguanosine
Time frame: 10 days
Claudin-3
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
- Results publication: PubMed 19903872Mehta NM, McAleer D, Hamilton S, Naples E, Leavitt K, Mitchell P, Duggan C. Challenges to optimal enteral nutrition in a multidisciplinary pediatric intensive care unit. JPEN J Parenter Enteral Nutr. 2010 Jan-Feb;34(1):38-45. doi: 10.1177/0148607109348065. Epub 2009 Nov 10.
- Results publication: PubMed 19202390Lopez-Herce J. Gastrointestinal complications in critically ill patients: what differs between adults and children? Curr Opin Clin Nutr Metab Care. 2009 Mar;12(2):180-5. doi: 10.1097/MCO.0b013e3283218285.
- Results publication: PubMed 21868501Pathan N, Burmester M, Adamovic T, Berk M, Ng KW, Betts H, Macrae D, Waddell S, Paul-Clark M, Nuamah R, Mein C, Levin M, Montana G, Mitchell JA. Intestinal injury and endotoxemia in children undergoing surgery for congenital heart disease. Am J Respir Crit Care Med. 2011 Dec 1;184(11):1261-9. doi: 10.1164/rccm.201104-0715OC. Epub 2011 Aug 25.
- Results publication: PubMed 22564954Mehta NM, Bechard LJ, Cahill N, Wang M, Day A, Duggan CP, Heyland DK. Nutritional practices and their relationship to clinical outcomes in critically ill children--an international multicenter cohort study*. Crit Care Med. 2012 Jul;40(7):2204-11. doi: 10.1097/CCM.0b013e31824e18a8.
- Results publication: PubMed 19398612Mehta NM, Compher C; A.S.P.E.N. Board of Directors. A.S.P.E.N. Clinical Guidelines: nutrition support of the critically ill child. JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):260-76. doi: 10.1177/0148607109333114. No abstract available.
- Results publication: PubMed 8788267Chellis MJ, Sanders SV, Webster H, Dean JM, Jackson D. Early enteral feeding in the pediatric intensive care unit. JPEN J Parenter Enteral Nutr. 1996 Jan-Feb;20(1):71-3. doi: 10.1177/014860719602000171.
- Results publication: PubMed 24403379Mikhailov TA, Kuhn EM, Manzi J, Christensen M, Collins M, Brown AM, Dechert R, Scanlon MC, Wakeham MK, Goday PS. Early enteral nutrition is associated with lower mortality in critically ill children. JPEN J Parenter Enteral Nutr. 2014 May;38(4):459-66. doi: 10.1177/0148607113517903. Epub 2014 Jan 8.
- Results publication: PubMed 21641735Aydemir C, Dilli D, Oguz SS, Ulu HO, Uras N, Erdeve O, Dilmen U. Serum intestinal fatty acid binding protein level for early diagnosis and prediction of severity of necrotizing enterocolitis. Early Hum Dev. 2011 Oct;87(10):659-61. doi: 10.1016/j.earlhumdev.2011.05.004. Epub 2011 Jun 8.
- Results publication: PubMed 22974599Reisinger KW, Van der Zee DC, Brouwers HA, Kramer BW, van Heurn LW, Buurman WA, Derikx JP. Noninvasive measurement of fecal calprotectin and serum amyloid A combined with intestinal fatty acid-binding protein in necrotizing enterocolitis. J Pediatr Surg. 2012 Sep;47(9):1640-5. doi: 10.1016/j.jpedsurg.2012.02.027.
- Results publication: PubMed 21245670Thuijls G, van Wijck K, Grootjans J, Derikx JP, van Bijnen AA, Heineman E, Dejong CH, Buurman WA, Poeze M. Early diagnosis of intestinal ischemia using urinary and plasma fatty acid binding proteins. Ann Surg. 2011 Feb;253(2):303-8. doi: 10.1097/SLA.0b013e318207a767.
- Results publication: PubMed 20381302van Haren FM, Pickkers P, Foudraine N, Heemskerk S, Sleigh J, van der Hoeven JG. The effects of methylene blue infusion on gastric tonometry and intestinal fatty acid binding protein levels in septic shock patients. J Crit Care. 2010 Jun;25(2):358.e1-7. doi: 10.1016/j.jcrc.2010.02.008. Epub 2010 Apr 8.
- Results publication: PubMed 23782971Piton G, Belon F, Cypriani B, Regnard J, Puyraveau M, Manzon C, Navellou JC, Capellier G. Enterocyte damage in critically ill patients is associated with shock condition and 28-day mortality. Crit Care Med. 2013 Sep;41(9):2169-76. doi: 10.1097/CCM.0b013e31828c26b5.
- Individual participant dataSharing planned: Yes. It is concluded the first phase of ERTEN-IFABP IN PICU.95 patients date were evaluated and the statistically significant results were obtained in the first observational phase of the study We conduct the second phase of our study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dincer Yildizdas, 3 study chair
Çukurova University Faculty of Medicine
Soyhan Bagcı, 2 study director
Bonn University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enteral Nutrition and Feeding Intolerance, run by Gazi University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif Keles, 1 (00905366741270, elifkeles.dr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IFABP (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02598375, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2016.