ACTRN12621001414808Recruiting未知
Effect of Early enteral nutrition on the duration of hospital stay after Paediatric Ostomy Closure (EPOC): A Prospective Randomised Controlled Trial
Sydney Children's Hospital Network0 sites40 target enrollmentStarted: October 20, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 3 Months to 16 Years (—)
- Sex
- All
Inclusion Criteria
- •Paediatric patients between the ages of 3 months and 16 years who can be expected to feed orally after undergoing elective enterostomy closure for the following indications and operation type;
- •- Elective closure of colostomy after Anorectal malformation (ARM) repair
- •- Elective closure of colostomy/ileostomy after pull-through for Hirschsprung's disease (HSCR)
- •- Elective closure of ileostomy after previous neonatal laparotomy for Necrotising enterocolitis (NEC), perforation, atresia or other intestinal pathology
- •- Elective closure of colostomy/ileostomy where the stoma was formed at a previous laparotomy for other intra-abdominal pathology.
Exclusion Criteria
- •Patients with short gut requiring long term total parenteral nutrition (TPN)
- •Patients undergoing a total colectomy or gastrostomy closure
- •Intercurrent conditions expected to affect bowel function (e.g., neurological impairment)
- •Patients who have been assessed to have unsafe swallow or laryngeal penetration with reflux and vomiting. This includes inability to protect the airway due to neurological impairment or structural abnormality, due to aspiration risk
- •Inability to obtain consent from parent/guardian
- •Patients requiring specific individualised feeding regime (e.g., metabolic disease)
- •Patients who require prolonged nasogastric tube (NGT) feeding
- •Patients requiring more than a simple enterostomy closure; i.e., extensive adhesiolysis or more than one anastomosis (in NEC)
- •Patients with Cystic Fibrosis or Inflammatory Bowel Disease.
Investigators
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