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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02814071




Registration number
NCT02814071
Ethics application status
Date submitted
23/05/2016
Date registered
27/06/2016
Date last updated
19/03/2020

Titles & IDs
Public title
Early Feeding in Acute Pancreatitis in Children
Scientific title
Early Feeding in Acute Pancreatitis in Children - A Randomised Controlled Trial
Secondary ID [1] 0 0
Early Feeding Pancreatitis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Pancreatitis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Early enteral feeding

No intervention: Fasting with intravenous fluids - The child will be kept fasted. Intravenous fluids will be at a rate and type as directed by the treating clinician. A low fat oral diet will be commenced once abdominal pain resolves and serum amylase/lipase levels decrease from the peak levels as per treating clinician. In the event that the patient is unable to tolerate oral feeding, tube feeding or parenteral nutrition may be commenced based on the clinical decision of the treating clinician(s). This will be recorded as an adverse event. Patients will be re-trialed on oral feeds once initial limiting symptoms or factors have improved or settled as per treating clinician's discretion

Experimental: Early enteral feeding - Patients will commence on an unrestricted oral diet within 24 hours of presentation, meeting 50% of EER with a regular diet and no fat restriction for the first 24 hours of enteral feeding. A 75-100% EER is targeted = 24 hours of enteral feeding.If the targeted EER is not met orally, a nasogastric tube will be inserted to provide bolus feeds of a standard formula with standard fat content. If the patient fails to tolerate both oral and bolus nasogastric tube feeding, continuous nasogastric tube feeding will be provided. If all fails, enteral nutrition by nasojejunal tube feeding or parenteral nutrition may be commenced based on the clinical decision. Patients will be re-trialed on oral feeds once initial limiting symptoms or factors have improved or settled.


Other interventions: Early enteral feeding
Early enteral feeding as per description
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to ready for discharge
Timepoint [1] 0 0
Time to ready for discharge- measured from onset of admission to time when medically assessed ready for discharge. Assessed between 5-10 days up to 14 days.
Secondary outcome [1] 0 0
Length of hospital stay
Timepoint [1] 0 0
Length of hospital stay- measured from onset of admission until time of actual discharge from hospital. Assessed between 5-10 days up to 14 days.
Secondary outcome [2] 0 0
Time to clinical resolution of acute pancreatitis
Timepoint [2] 0 0
Time to clinical resolution of acute pancreatitis- time from onset of hospital admission until painfree and absence of nausea with no need for analgesia or other symptomatic therapy. Assessed between 5-10 days up to 14 days.
Secondary outcome [3] 0 0
Time to biochemical resolution of acute pancreatitis
Timepoint [3] 0 0
Time to biochemical resolution of acute pancreatitis- time from onset of hospital admission to resolution of lipase and/or amylase below upper limit of normal. Assessed between 5-10 days up to 14 days.

Eligibility
Key inclusion criteria
1. Diagnosis of acute pancreatitis according to international consensus criteria (Morinville et al. JPGN 2012), which requires at least 2 of the 3 following criteria:

* Abdominal pain compatible with acute pancreatitis
* Serum amylase and/or lipase = 3 times upper limits of normal
* Imaging findings consistent with acute pancreatitis Each episode of acute recurrent pancreatitis will be accepted if each episode is distinct, at least 4 weeks apart from previous episode with intervening normalisation of serum amylase and lipase.
2. Age 3-18 years.
3. Hemodynamically stable.
4. Ability to consent and participate in the study and follow study procedures.
Minimum age
3 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe pancreatitis associated with organ dysfunction and requiring intensive care admission at presentation.
2. Biliary cause of pancreatitis including gallstone pancreatitis and choledochal cyst
3. Autoimmune pancreatitis.
4. High grade traumatic pancreatitis including partial or complete disruption of the pancreatic duct.
5. Presence of other conditions restricting enteral nutrition.
6. Different treatment approach taken by treating clinician due to medical reasons.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/04/2019
Sample size
Target
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Department of Pediatric Gastroenterology, Sydney Children's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Shaare Zedek Medical Center
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Acute pancreatitis (AP) in children has an increasing incidence and is at times associated with significant morbidity and mortality. Despite this, there is no high-quality evidence-based treatment for childhood AP and current practice is based entirely on historical approach and extrapolation from adult studies.

In this study, we evaluate the use of early enteral feeding in children with AP. The traditional approach to treating AP relies on fasting and intravenous fluids (or occasionally parenteral nutrition) assuming that this minimizes stimulation of an already inflamed pancreas. Contrary to this, evidence exists that early feeding of patients with AP may be beneficial. Randomized controlled trials of fasting vs. early oral diet in adult patients with mild AP, showed no differences in pain, serum amylase and CRP levels, but also shorter hospital stay in those fed earlier. Further data in adults with severe AP demonstrated that early enteral nutrition was associated with decreased mortality, infections and multiorgan failure. These benefits were lost if enteral nutrition was commenced 48 hour after admission. Suggested explanations for these findings include the possibility that enteral nutrition may maintain integrity and function of intestinal mucosa and reduce gut-origin sepsis.

Historically, nasojejunal (NJ) feeds were felt to be safer than oral or nasogastric feeds in the setting of AP by avoiding cephalic and gastric pancreatic stimulation. NJ feeds require moderately invasive tube insertion under radiographic or endoscopic guidance. Recent data suggest that oral feeding with a low fat diet was as safe as NJ feeding.

Several animal models of AP demonstrate that the exocrine pancreas is resistant to cholecystokinin (CCK) stimulation after the onset of AP, suggesting a mechanism for the lack of concern of exacerbating pancreatitis with enteral feeds.

Considering this data it is less certain that diet and fat restriction contribute to treatment of AP. To further challenge the prior conceptions of AP management it is necessary to explore the use of unrestricted diet (full fat) in mild-moderate pediatric AP, a population with recognized low complication risk.

Despite the mounting evidence to the contrary, it is still standard clinical practice to fast children with AP, and only slowly reintroduce feeds depending on the clinical improvement. This is largely due to the lack of clinical interventional studies in children with AP.
Trial website
https://clinicaltrials.gov/study/NCT02814071
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Oren Ledder, Dr.
Address 0 0
Department of Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02814071