Clinical trial NCT03820128: Early Nutrition in Acute Pancreatitis
Official title: Very Early and Early Nutrition in Acute Pancreatitis in Children: a Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pancreatitis
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 84
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to assess the effect of the early oral refeeding and fat content in the diet on the length of stay, clinical course (included pain severity) in pediatric patients with mild and moderate AP. Patients will be randomized to groups: refeeding within 24 hours or after 24 hours from the hospital admission. Biochemical tests and pain severity will be evaluated.

Detailed description: Prospective, randomized study. Research in the adult population shows that early enteral feeding in acute pancreatitis (AP) both oral and via the feeding tube is safe, shortens the length of hospital stay, prevents the multi organ failure (MoF) and reduces mortality. The pediatric population lacks prospective data concerning refeeding modes in AP. The aim of the study is to assess the effect of the early oral refeeding and fat content in the diet on the length of stay, clinical course (included pain severity) in pediatric patients with mild and moderate AP. Patients will be randomized to groups: refeeding within 24 hours or after 24 hours from the hospital admission. Biochemical tests including CRP, amylase, lipase and proinflammatory cytokines levels and zonulin level as well as severity of pain will be assessed again in the second, the third and the fifth hospital day.

Eligibility criteria: Inclusion Criteria:

* AP diagnosis according to the generally accepted criteria ie. fulfilling two out of three criteria:

  * Abdominal pain of pancreatic origin
  * Radiologic findings supportive of AP on imaging
  * Amylase or lipase levels elevation three times above the upper limit of normal
* Mild or moderate AP Mild AP: AP without organ failure, local or general complications Moderate AP: AP that may be accompanied by intermittent organ failure, local complications or concomitant disease worsening
* No contradictions to enteral treatment
* Informed consent from the parents or legal guardian and from the patient if older than 16 years

Exclusion Criteria:

* Severe general condition
* Severe AP
* Kidney insufficiency, cardiac insufficiency
* Diabetes type 1
* Cystic fibrosis
* Contraindications to enteral feeding
* Lack of required informed consent

Primary outcomes:
measure: Length of hospitalization
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Time between the onset of symptoms and the first feeding
timeFrame: assessed at the day of 2
measure: Adverse events
timeFrame: daily assessment in the first three days of hospitalization
measure: Average calories intake
timeFrame: through study completion, an average of 2 years
measure: Levels of proinflammatory cytokine levels.
timeFrame: through study completion, an average of 2 years
measure: Zonulin level
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Departement of Paediatric Gastroenterology and Nutrition.
Study officials:
References: