Tolerability and safety of early enteral nutrition in children after percutaneous endoscopic gastrostomy placement: A multicentre randomised controlled trial.

BACKGROUND & AIMS: We assessed the tolerability and safety of implementing early enteral nutrition in children at 3 h after percutaneous endoscopic gastrostomy (PEG) placement to establish an optimum feeding mode in paediatric patients that reduced the fasting period, the inadequate nutritional support interval, and the hospitalisation time.

METHODS: Children with clinical indications for PEG placement were recruited from six medical centres in Poland to participate in the study. The patients were centrally randomised to receive the first bolus feed, which comprised a polymeric diet (1 kcal/mL), via a feeding tube at 3 h (group 1) or 8 h (group 2) after PEG placement. The pre-procedural preparation, the post-operative care, and the resumption of feeding were performed on all of the patients in accordance with the study's protocol. The primary endpoint was the number of patients who consumed a full feed, which contained their total fluid and caloric requirements, within 48 h of the first bolus feed. The secondary endpoints were the number of complications and the duration of hospitalisation after PEG placement.

RESULTS: Of the 97 randomised patients, 49 were assigned to group 1 and 48 were assigned to group 2. There were no differences between the groups regarding feeding tolerability (81.6% vs. 91.6%), the number of complications (25.5% vs. 37.5%), or the duration of hospitalisation after PEG placement (p > 0.05). Full feed post PEG placement was achieved within 24-48 h in most cases (74% vs. 82%). Most of the complications were mild. Two patients in group 2 due to dislocation of the PEG were qualified for laparotomy (at 6 days post-PEG placement in one case and at 14 days post-PEG placement in the other case). One patient in group 2 died at 7 days post-PEG placement; the death was unrelated to the investigation.

CONCLUSIONS: Introducing feeding at 3 h post-PEG placement in children appears to be well tolerated. The early initiation of post-PEG feeding was not associated with an increase in the number of complications and it had no impact on the duration of hospitalisation. CLINICAL TRIAL REGISTRY: www.clinicaltrials.gov (NCT02777541; registration date: 18/05/2016).