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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

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]

Early Feeding Pancreatitis

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute Pancreatitis

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]

Other interventions

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Time to ready for discharge

Timepoint [1]

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]

Length of hospital stay

Timepoint [1]

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]

Time to clinical resolution of acute pancreatitis

Timepoint [2]

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]

Time to biochemical resolution of acute pancreatitis

Timepoint [3]

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?

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

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

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Department of Pediatric Gastroenterology, Sydney Children's Hospital - Sydney

Recruitment postcode(s) [1]

- 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

Oren Ledder, Dr.

Address

Department of Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02814071

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