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Trial record 1 of 37 for:    polyethylene glycol safety in children
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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
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Description
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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.


Condition or disease Intervention/treatment
Polyethylene Glycols Children, Only Drug: PEG 3350

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 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Children who are taking 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.
 Drug: PEG 3350

Data and biospecimens will be collected from two groups of children:

  • Children who have taken PEG 3350 daily for at least 30 days.
  • Children who have NOT taken PEG 3350 for at least 30 days.

No changes to medicines are recommended as part of this study.
Children who are not taking PEG 3350
  • Children less than 17 years old who have NOT taken PEG 3350 for at least 30 days.

Children in three subgroups will be included:

  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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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%.


  7. 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)

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   0 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study population will be selected from children cared for at The Children's Hospital of Philadelphia.
Criteria

Group 1: Children currently taking PEG 3350.

Inclusion Criteria:

  • Children less than 17 years old who have been taking PEG 3350 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.

Group 2: Children who are not currently taking PEG 3350.

Inclusion criteria:

• Children less than 17 years old who have NOT taken PEG 3350 for at least 30 days.

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Amanda DeGunia, MA 215-590-2603 deguniaa@chop.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Amanda DeGunia, MA       deguniaa@chop.edu   
Principal Investigator: Robert O. Heuckeroth, MD, PhD         
Sponsors and Collaborators
Children's Hospital of Philadelphia
Food and Drug Administration (FDA)
Investigators
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Principal Investigator: Robert O Heuckeroth, MD, PhD Children's Hospital of Philadelphia
More Information
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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT05424757    
Other Study ID Numbers: 14-011454
1R01FD005312-01 ( U.S. FDA Grant/Contract )
First Posted: June 21, 2022    Key Record Dates
Last Update Posted: October 5, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents