SODIUM HYDROGEN CARBONATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; MACROGOL 3350 (polyethylene glycol 3350) for Constipation

Inclusion criteria

• {"criterion_text":"- o Paediatric patients admitted to the PICU (1 month-16 years of age) for an estimated time of more than 3 days."}
• {"criterion_text":"- o Patients whose parents or legal guardians sign the informed consent form. In the case of mature minors (12-16 years of age), they will have to agree to be included."}
• {"criterion_text":"- o Patients with a constipation development risk scale (Appendix 1) with a score > 6.2 points (high risk) assessed 48 hours after admission to PICU (day 0)."}

Exclusion criteria

• {"criterion_text":"- Patients previously affected or who at the time of admission present abdominal pathology involving gastrointestinal rhythm alteration (short bowel syndrome, paralytic ileus, etc.) and/or gastrointestinal surgery.."}
• {"criterion_text":"- Patients who at 48 hours of admission to the PICU (Day 0) have not reached 80% of full enteral nutrition calculated for their weight and height (Appendix 4)."}
• {"criterion_text":"- Patients who have spontaneous transit before 48 hours of admission."}
• {"criterion_text":"- Patients with chronic constipation and already undergoing pharmacological treatment for constipation regardless of the drug used."}
• {"criterion_text":"- Women of childbearing age who are unwilling or unable to use an effective barrier method of contraception."}
• {"criterion_text":"- Hypersensitivity to any component of the study drug formulation."}

Primary endpoints

• {"endpoint_text":"- Efficacy assessment: the primary endpoint is stool output.","definition_or_measurement_approach":"the primary endpoint is stool output."}

Secondary endpoints

• {"endpoint_text":"- •\t Safety assessment: any adverse events","definition_or_measurement_approach":"Safety assessed as any adverse events."}
• {"endpoint_text":"- Assessment of stool consistency: the validated Bristol scale will be used.","definition_or_measurement_approach":"Stool consistency measured using the validated Bristol scale."}

Spain

Earliest CTIS Part Ii Submission Date

23-12-2024

Latest Decision Or Authorization Date

04-02-2025

Processing Time Days

43

Number Of Sites

1

Number Of Participants

233

Primary sponsor

Full Name

Hospital General Universitario Gregorio Maranon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain