Polyethylene Glycol Safety in Children
- Registration Number
- NCT05424757
- Lead Sponsor
- Children's Hospital of Philadelphia
- Brief Summary
The primary objective is to measure levels of selected PEG 3350 components and metabolites in the blood and urine of children who are already taking PEG 3350 compared to children who are not taking PEG 3350.
Changes to medical therapy are not recommended as part of this study.
- Detailed Description
For subjects taking PEG 3350, blood and urine will be collected 1.5 to 4 hours after subjects take PEG 3350.
For subjects who are not taking PEG 3350, the same PEG 3350 components and metabolites will be measured in blood and urine.
PEG 3350 containing medicines from study subjects will be analyzed for the same PEG 3350 components and metabolites.
A stool specimen will be collected for future studies.
Additional data will be obtained from:
* Review of medical records.
* A brief questionnaire.
* Child Behavior Checklist (CBCL) from the Achenbach System of Empirically Based Assessment (for children more than 1.5 years old)
* Bayley-IV Social-Emotional Scale assessment (for children less than 1.5 years old)
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 158
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Children who are taking PEG 3350 PEG 3350 * Children less than 17 years old who have taken PEG 3350 daily for at least 30 days. * Dose of PEG 3350 greater than or equal to 0.4 grams/kg/day. * Preference will be given to children taking at least 17 grams/day. Notes: Only children who are already taking PEG 3350 as part of their current medical regimen will be included. Changes to medical therapy are not recommended as part of this study. Children in three subgroups will be enrolled: 1. Children with no known bowel or nervous system disease or neuropsychiatric symptoms. 2. Children with bowel problems that might increase intestinal permeability. 3. Children with neurologic disease or with neuropsychiatric disorders or symptoms.
- Primary Outcome Measures
Name Time Method PEG 3350 related molecules in plasma 15 minutes Plasma levels of selected PEG 3350 related molecules will be measured by mass spectrometry using validated assays.
PEG 3350 related molecules in urine 10 minutes Urine levels of selected PEG 3350 related molecules will be measured by mass spectrometry using validated assays.
PEG 3350 related molecules in medicine samples 5 minutes Medicine sample levels of selected PEG 3350 related molecules will be measured by mass spectrometry using validated assays.
Baseline neurobehavioral symptoms in children who are not taking PEG 3350 5 minutes Participants will complete a short symptom questionnaire specific to this study.
Assessment of current Child behavior (1.5 years to 18 years old) 30 minutes Families with children \>1.5 years to 18 years old will complete an age-appropriate Child Behavior Checklist (CBCL) from the Achenbach System of Empirically Based Assessment. Specific CBCL forms are available for ages 1.5 to 5 years and for 6 to 18 years.
Standard scores are scaled. 50 is average for age and gender. Standard deviation is 10 points. Higher scores indicate greater problems. Normal = below 93%. Borderline = 93-97%. Clinical range = above 97%.Assessment of current Child behavior (< 1.5 years old) 90 minutes Caregivers with children \< 1.5 years old will complete a Bayley-4 Social-Emotional Scale (BSID-IV) assessment. The BSID-IV Social-Emotional Scale is an adaptation of the Greenspan Social-Emotional Growth Chart: A Screening Questionnaire for Infants and Young Children. The Social-Emotional Scale assesses acquisition of social and emotional milestones.
Items assess mastery of functional emotional skills, such as self-regulation and interest in the world; communicating needs; engaging others and establishing relationships; using emotions in a purposeful manner; and using emotional signals to solve problems.
The standardized mean motor score is 100 (SD 15), with scores lower than 85 indicating mild impairment, and lower than 70 indicating moderate or severe impairment.Neurobehavioral symptoms in children who are taking PEG 3350 5 minutes Participants will complete a short symptom questionnaire specific to this study. The questionnaire asks if specific symptoms are present and if they changed after the child started PEG 3350 containing medicine.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States