Polyethylene Glycol Safety in Children
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|ClinicalTrials.gov Identifier: NCT05424757|
Recruitment Status : Recruiting
First Posted : June 21, 2022
Last Update Posted : October 5, 2022
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.
|Condition or disease||Intervention/treatment|
|Polyethylene Glycols Children, Only||Drug: PEG 3350|
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 study.
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-III Social-Emotional Scale assessment (for children less than 1.5 years old)
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||150 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Quantitative Analysis of Selected PEG 3350 Components and Metabolites in Children's Plasma and Urine|
|Actual Study Start Date :||September 30, 2022|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||June 2024|
Children who are taking PEG 3350
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:
Drug: PEG 3350
Data and biospecimens will be collected from two groups of children:
No changes to medicines are recommended as part of this study.
Children who are not taking PEG 3350
Children in three subgroups will be included:
- PEG 3350 related molecules in plasma [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 5 minutes ]Medicine sample levels of selected PEG 3350 related molecules will be measured by mass spectrometry using validated assays.
- Neurobehavioral symptoms in children who are taking PEG 3350 [ Time Frame: 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.
- Baseline neurobehavioral symptoms in children who are not taking PEG 3350 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 90 minutes ]
Caregivers with children < 1.5 years old will complete a Bayley-III Social-Emotional Scale (BSID-III) assessment. The BSID-III 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.
Biospecimen Retention: Samples Without DNA
- Blood: 1.5 mL (up to 6 months of age), 2.5 mL (6 to 24 months old), 5 mL (older than 24 months). No more than 3 mL/kg will be collected from any child.
- Urine (10 mL)
- Stool (10-20 grams for possible future analyses)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05424757
|Contact: Amanda DeGunia, MAemail@example.com|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Amanda DeGunia, MA firstname.lastname@example.org|
|Principal Investigator: Robert O. Heuckeroth, MD, PhD|
|Principal Investigator:||Robert O Heuckeroth, MD, PhD||Children's Hospital of Philadelphia|