Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to explore the quantity of excipient exposure in neonatal and young pediatric patients in a Danish Hospital. The focus will be on the preservatives ethanol, propyl glycol, benzyl alcohol, methyl-p-hydroxybenzoate and propanyl-p-hydroxybenzoate and the artificial sweeteners acesulfam potassium, aspartame, glycerol and sorbitol.


Clinical Trial Description

Studies have previously examined whether or not neonatal nor pediatric patients are exposed to excipients and what excipients they are possibly exposed to. They have shown that practically all neonatal patients receive one or more drug containing an excipient, known to be harmful. This observational study will look at both registered drugs and extemporaneous pharmaceuticals as possible sources of excipients. Based on information provided by the manufacturer (ex. the index-list), the investigator will calculate the amounts of excipients administered to the patient a week after hospitalisation. The investigator will calculate the blood alcohol content when the neonatal patient are exposed to ethanol and/or propylene glycol.

By grouping the patients according to age and subgrouping according to diagnosis/affected organ system and compare the amount of excipient exposure in each group, the study aims at identifying the most vulnerable neonatal and/or pediatric patients in terms of the amount and identity of excipients accumulated in the patient.

The study will use a descriptive, parametric statistic analysis to identify

- an average exposure rate (concentration i mg/l or amount in mg) of each of the listed excipients

- how much the average patient in each age-group is exposed to each excipient

- how much the average patient in each "affected organ system"-subgroup is exposed to each excipient ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02545712
Study type Observational
Source Bispebjerg Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date January 2016

See also
  Status Clinical Trial Phase
Completed NCT04176822 - Designing Animated Movie for Preoperative Period N/A
Completed NCT01981954 - A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO) Phase 3
Completed NCT02199626 - SECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD). Phase 4
Recruiting NCT04679792 - Postual Control in Pediatric Chiari I Malformation
Recruiting NCT06061159 - The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction Phase 4
Active, not recruiting NCT05453968 - Berotralstat Treatment in Children With Hereditary Angioedema Phase 3
Not yet recruiting NCT02182648 - Bispectral Index Guiding Etomidate Used in Children Aged 3 to 10 for Clinical Anesthesia Induction Phase 4
Active, not recruiting NCT04176640 - Quantifying Brain Injury on Computed Tomography in Hospitalized Children
Active, not recruiting NCT06146452 - Micronutrient Status in Pediatric Palliative Care
Completed NCT04041180 - Impact on the Length of Stay in Incentive Spirometry and Pain in the Decompensation of Sickle Cell Disease: .
Not yet recruiting NCT06165003 - Examination of Nurses' Use of Broselow Tape in Non-resuscitation Pediatric Emergency Department Practices N/A
Recruiting NCT02286297 - Pediatric Endotracheal Intubation During Resuscitation N/A
Unknown status NCT00613184 - Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses N/A
Recruiting NCT00265772 - Comparison of a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis Phase 4
Completed NCT04106063 - A New Speech, Spatial, and Qualities of Hearing Scale Short-Form for Deaf Children
Not yet recruiting NCT06376643 - Augmented Reality to Support Cardiopulmonary Resuscitation N/A
Not yet recruiting NCT05511233 - ERAS Protocol in Newborns: CARES Study N/A
Not yet recruiting NCT04127968 - Efficacy and Safety of Vitamin A Treatment for Children With Sepsis N/A
Active, not recruiting NCT04472286 - Healthy Bones, Healthy Life: Habitual Physical Activity on Bone & Metabolic Health in Pediatric Cancer Survivors
Recruiting NCT05909878 - Virtual Reality Distraction for Anxiety (VR-IMAGINE at HSJ) N/A