Early Feeding in Acute Pancreatitis in Children
Condition: Acute Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional

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.
    

Detailed description: 
      This is a prospective, randomized controlled trial in children with acute pancreatitis, which
      aims to demonstrate that, compared with the current standard approach of fasting with
      intravenous fluids, early enteral (oral or nasogastric) feeding with standard diet or formula
      will improve the following measures of outcome:

        1. Length of hospital admission.

        2. Serum amylase, lipase, electrolytes, calcium, magnesium, phosphate, urea, creatinine,
           liver function tests, C-reactive protein (biomarker of inflammation), and full blood
           count - routine blood tests performed daily until normalisation of serum lipase or until
           discharge and as directed by treating clinician thereafter.

        3. Weight at presentation and "ready for discharge", and at day 30 post-discharge clinic
           review.

        4. Systemic complications including hemodynamic instability, renal failure, intensive care
           admission.

        5. Analgesic requirement.

        6. Local complications including pancreatic necrosis, abscess, pseudocyst.

        7. Abdominal ultrasound findings during hospital admission (or other abdominal imaging as
           directed by treating clinicians).

      At day 30-60 post-discharge, a routine ultrasound (to assess for localized complication(s)
      e.g. pseudocyst) and clinical follow-up will be undertaken.
    

Intervention name(s): Early enteral feeding
Intervention type(s): Other
Intervention description(s): Early enteral feeding as per description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Early Feeding; Acute Pancreatitis; Pediatric