Study on Preventing Constipation in Critically Ill Children Using Macrogol 3350, Sodium Hydrogen Carbonate, Potassium Chloride, and Sodium Chloride

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What is this study about?

This clinical trial is focused on studying the prevention of constipation in critically ill children. Constipation is a common issue where a person has difficulty in passing stools. The treatment being tested in this study is a medication called Movicol Pediátrico Sabor Neutro, which is an oral solution containing a combination of substances: sodium hydrogen carbonate, potassium chloride, sodium chloride, and macrogol 3350. These ingredients work together to help soften stools and make them easier to pass.

The purpose of the study is to test how effective this treatment is in preventing constipation in children who are critically ill. The study will involve children who are admitted to the Pediatric Intensive Care Unit (PICU) and are at high risk of developing constipation. Participants will receive either the treatment or a placebo, and their stool output will be monitored to assess the treatment’s effectiveness. The study will also look at the safety of the treatment by monitoring any adverse events and assessing stool consistency using a tool called the Bristol scale.

The study will take place over a period of time, with children being observed for changes in their bowel movements. The goal is to determine if the treatment can successfully prevent constipation in these vulnerable patients, improving their comfort and overall health during their stay in the PICU.

1 admission to the pediatric intensive care unit (PICU)

Upon admission to the PICU, eligibility for the trial is assessed. This includes being between 1 month and 16 years of age and having an expected stay of more than 3 days.

A risk scale for developing constipation is used. A score greater than 6.2 points indicates high risk and eligibility for the trial.

2 informed consent

Parents or legal guardians must sign an informed consent form. For minors aged 12 to 16, agreement to participate is also required.

3 initiation of treatment

The treatment involves the administration of Movicol Pediátrico Sabor Neutro, an oral solution containing sodium hydrogen carbonate, potassium chloride, sodium chloride, and macrogol 3350.

The medication is taken orally as a prophylactic treatment to prevent constipation.

4 monitoring and assessment

The primary endpoint is the assessment of stool output to evaluate the efficacy of the treatment.

Secondary assessments include monitoring for any adverse events and evaluating stool consistency using the Bristol scale.

5 completion of trial participation

The trial is estimated to end on December 31, 2025. Participation continues until the end of the trial or discharge from the PICU, whichever comes first.

Who Can Join the Study?

Children who are patients in the Pediatric Intensive Care Unit (PICU) and are expected to stay for more than 3 days.
Children between the ages of 1 month and 16 years.
Parents or legal guardians must sign a form giving their permission for the child to participate. If the child is between 12 and 16 years old, they must also agree to participate.
Children who have a high risk of developing constipation. This is determined by a special score that is more than 6.2 points, checked 48 hours after they are admitted to the PICU.

Who Cannot Join the Study?

Children who are not critically ill cannot participate.
Children who are not at risk of developing constipation cannot participate. Constipation means having difficulty in passing stools or not being able to have a bowel movement regularly.
Children who are not within the specified age range cannot participate. The age range for this study is from 2 years old.
Children who have any medical condition that the study doctors think might interfere with the study cannot participate.
Children who are already taking medications that might affect the study results cannot participate.
Children who have allergies to the study medication or its ingredients cannot participate.
Children who are participating in another clinical trial cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hospital General Universitario Gregorio Maranon	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.01.2025

Trial locations

Investigated drugs:

Polyethylene Glycol with Electrolytes: This medication is used to prevent constipation. It works by holding water in the stool, which helps to soften it and make it easier to pass. In this trial, it is being tested to see if it can effectively prevent constipation in critically ill children.

Constipation – Constipation is a common condition where an individual experiences difficulty in passing stools or has infrequent bowel movements. It often results in hard, dry stools that are difficult to pass. This condition can cause discomfort, bloating, and a feeling of incomplete evacuation. Constipation can be caused by a variety of factors, including diet, lifestyle, and certain medications. It may also be associated with changes in routine or stress. In some cases, constipation can lead to complications such as hemorrhoids or anal fissures if not managed properly.

Trial ID:

2023-509718-12-01

Protocol code:

PEM3350

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Preventing Constipation in Critically Ill Children Using Macrogol 3350, Sodium Hydrogen Carbonate, Potassium Chloride, and Sodium Chloride

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?