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Effect of early feeding on the regulation of autophagy in critically ill children

Effect of early feeding on the regulation of autophagy in critically ill children

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000544279
Enrollment
3
Registered
2018-04-11
Start date
2018-03-05
Completion date
Unknown
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A recent large randomized trial has shown that a later start with supplementary parenteral nutrition when enteral nutrition is not working in full reduces ICU patient’s disease and length of ICU treatment. This has been shown in both adult and pediatric ICU patients. It has been hypothesized from these trails, that the early supplementary parenteral nutrition inhibits autophagy in cells. Autophagy is the cellular process that degrades larger proteins and organelles especially when they are damaged. The hypothesized inhibition of the autophagy process will then lead to the buildup of more damaged proteins and prolong/worsen the cellular and thereby organ function. At the pediatric ICU management, has decided to change the routine from early supplementary parenteral nutrition (day 2) to a later day (day 5) based on the clinical outcome trials. We will use this change to investigate the effect of initiating early feeding and later feeding on the potential of the patient’s serum to inhibit the autophagy flux in an in vitro model. There are no methods available to measure the autophagy flux in vivo in humans. In addition, we will relate the changes in autophagy flux to nutrients concentrations and clinical parameters.

Interventions

Supplementary parenteral nutrition when enteral nutrition is not up to target on day 5 Nutritional target is defined as: energy target according to Schofield equation. For enteral nutrition different formulas are used depending on age and are given continuously either via nasogastric or post-pyloric tube (decided by the treating clinician). Supplementary parenteral nutrition is given as different commercial formulas (Baxter): Numeta G16E (<10 kg body weight); Numeta G19E (10-15 kg body weigh

Supplementary parenteral nutrition when enteral nutrition is not up to target on day 5 Nutritional target is defined as: energy target according to Schofield equation. For enteral nutrition different formulas are used depending on age and are given continuously either via nasogastric or post-pyloric tube (decided by the treating clinician). Supplementary parenteral nutrition is given as different commercial formulas (Baxter): Numeta G16E (<10 kg body weight); Numeta G19E (10-15 kg body weight) and Olimel N5 (>15kg body weight). The amount given is: 67% of total nutritional target on day 5-6; 85% of total nutritional target on day 7-8 and 100% of total nutritional target from day 9 as long as in the ICU. The intervention is ordinated by treating clinician and administered by treating nurse.

Sponsors

Urban Fläring
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

Treated at pediatric ICU; ongoing mechanical ventilation; Two or more failing organs; expected ICU stay of more than 2 days

Exclusion criteria

No informed consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026