General information
  • Disease category Other (BASEC)
  • Recruitment status recruitment ongoing (BASEC/ICTRP)
  • Trial sites
    Zurich
    (BASEC)
  • Contact Luregn Schlapbach research.ipsneo@kispi.uzh.ch (BASEC)
  • Data Source(s) BASEC: Import from 12.05.2025 ICTRP: N/A
  • Last update 12.05.2025 15:55
HumRes66163 | SNCTP000006200 | BASEC2024-00669

GASTRIC-PICU: Study on the usefulness of measuring gastric residual volume in children in intensive care

  • Disease category Other (BASEC)
  • Recruitment status recruitment ongoing (BASEC/ICTRP)
  • Trial sites
    Zurich
    (BASEC)
  • Contact Luregn Schlapbach research.ipsneo@kispi.uzh.ch (BASEC)
  • Data Source(s) BASEC: Import from 12.05.2025 ICTRP: N/A
  • Last update 12.05.2025 15:55

Summary description of the study

In our research project, we want to find out whether routine measurements of gastric contents in children are necessary or not. Children in intensive care and on mechanical ventilation often struggle to take in even half of the required calories (through food). An adequate caloric intake for a sick child is important so that he/she has enough energy for breathing and recovery. Currently, the gastric residual volume is regularly measured in every child. As soon as this gastric residual shows an abnormal amount or color, the staff may, after consultation, reduce or stop feeding. This could be a reason why these children do not receive sufficient calories.

(BASEC)

Intervention under investigation

When participating in the study, the child will be randomly assigned to one of two groups:

• No measurement of gastric residual volume (GRV) (intervention group)

• Standard measurement of GRV (comparison group)

The rest of the child's treatment will not be influenced by the study. Care continues according to the therapeutic guidelines of the treating medical and nursing team.

(BASEC)

Disease under investigation

We want to know if measuring gastric residual volume affects ventilation and if caloric intake can be increased.

(BASEC)

Criteria for participation in trial
Children and adolescents who can be included in this study must meet the following criteria: o Patient in intensive care o Already mechanically ventilated or expected intubation o Age 0-16 years o Intention to start or already started feeding via gastric tube or PEG. (BASEC)

Exclusion criteria
Children and adolescents cannot participate in this study if the following applies to them: • Already a patient in intensive care for more than 24 hours • Postpyloric feeding tubes or jejunostomy • Palliative patients • Children/adolescents with long-term invasive mechanical ventilation • Current or recently occurred intestinal disease or surgery (e.g., necrotizing enterocolitis (NEC), active gastrointestinal bleeding, or intestinal surgery) • Participated in the GASTRIC-PICU study in the last six months. (BASEC)

Trial sites

Zurich

(BASEC)

not available

Sponsor

Universitäts-Kinderspital Zürich

(BASEC)

Contact

Contact Person Switzerland

Luregn Schlapbach

+41 44 249 6211

research.ipsneo@kispi.uzh.ch

Universitäts-Kinderspital Zürich, Intensivmedizin und Neonatologie

(BASEC)

Scientific Information

not available

Name of the authorising ethics committee (for multicentre studies, only the lead committee)

Ethics Committee Zurich

(BASEC)

Date of authorisation

10.12.2024

(BASEC)


ICTRP Trial ID
not available

Official title (approved by ethics committee)
The GASTRIC-PICU Study: A randomised controlled trial of no routine gastric residual monitoring to guide enteral feeding in paediatric intensive care units (BASEC)

Academic title
not available

Public title
not available

Disease under investigation
not available

Intervention under investigation
not available

Type of trial
not available

Trial design
not available

Inclusion/Exclusion criteria
not available

not available

Primary and secondary end points
not available

not available

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
not available

Additional contacts
not available

Secondary trial IDs
not available

Results-Individual Participant Data (IPD)
not available

Further information on the trial
not available

Results of the trial

Results summary

not available

Link to the results in the primary register

not available