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prophylactic treatment of constipation with polyethylene glycol with electrolytes in the critically ill child.
EU CTIS ID: 2023-509718-12-01
What this study is testing
To test the efficacy of prophylactic treatment with PEG3350+E to prevent the onset of constipation in the critically ill child.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- o Paediatric patients admitted to the PICU (1 month-16 years of age) for an estimated time of more than 3 days. 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. 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).
You likely can't join if
- 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.. 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). Patients who have spontaneous transit before 48 hours of admission. Patients with chronic constipation and already undergoing pharmacological treatment for constipation regardless of the drug used. Women of childbearing age who are unwilling or unable to use an effective barrier method of contraception. Hypersensitivity to any component of the study drug formulation.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.