Topics

Safe Excipient Exposure in Neonates

2015-09-14 03:14:40 | BioPortfolio

Summary

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

Description

Studies have previously examined whether or not neonatal 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 when they receive ≥10 drugs. The investigator will calculate the blood alcohol content when the neonatal patient are exposed to ethanol and/or propylene glycol.

By grouping the neonatal patients 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 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 neonatal patient in each "affected organ system"-groups is exposed to each excipient

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Conditions

Excipient Exposure

Intervention

Exposure to ethanol, Exposure to propylene glycol, Exposure to benzyl alcohol, Exposure to acesulfam potassium, Exposure to aspartame, Exposure to glycerin

Status

Not yet recruiting

Source

Bispebjerg Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-09-14T03:14:40-0400

Clinical Trials [4205 Associated Clinical Trials listed on BioPortfolio]

Phase IIa Study of Fomepizole for Acetaldehyde Toxicity After Ethanol Exposure in Subjects With Altered Ethanol Metabolism

This trial will evaluate if fomepizole (4-methylpyrazole)can treat symptoms associated with alcohol intolerance due to aldehyde dehydrogenase 2 (ALDH2) Deficiency, an inherited metabolic d...

Does the Threat of an Aversive Reaction Affect Craving of Alcohol During Cue Exposure in Alcohol Dependent Patients?

To evaluate the effect of the threat of an aversive reaction on the response during alcohol cue exposure in alcohol dependent patients : (1) the subjective response (craving) and (2) the p...

Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients

This is a single arm, open label study designed to evaluate the safety and efficacy of propylene glycol-free melphalan hydrochloride in patients with AL amyloidosis. Treatment will be comp...

Methods for Managing Intrusive Thoughts

The current study sought to translate laboratory research on learning and memory to better understand the mechanisms and methods for implementing exposure therapy for unwanted obsessional ...

EMA for the Exposure to Alcohol Advertisements

The present proposed study has 3 primary objectives to address the knowledge gap regarding the exposure to alcohol advertisements in university students: (1) To estimate the frequency of e...

PubMed Articles [10543 Associated PubMed Articles listed on BioPortfolio]

Adolescent but not adult ethanol binge drinking modulates ethanol behavioral effects in mice later in life.

Alcohol use disorder is a serious illness marked by uncontrollable drinking and a negative withdrawal state when not using. Alcohol is one of the most commonly used drugs among adolescent populations....

Prenatal alcohol exposure and facial morphology in a UK cohort.

High levels of prenatal alcohol exposure are known to cause an array of adverse outcomes including fetal alcohol syndrome (FAS); however, the effects of low to moderate exposure are less-well characte...

Ethanol Exposure Transiently Elevates but Persistently Inhibits Tyrosine Kinase Activity and Impairs the Growth of the Nascent Apical Dendrite.

Dendritogenesis can be impaired by exposure to alcohol, and aspects of this impairment share phenotypic similarities to dendritic defects observed after blockade of the Reelin-Dab1 tyrosine kinase sig...

MicroRNA-34a mediates ethanol-induced impairment of neural differentiation of neural crest cells by targeting autophagy-related gene 9a.

Neural crest cells (NCCs) are multipotent progenitor cells that are sensitive to ethanol and are implicated in Fetal Alcohol Spectrum Disorders (FASD). The objective of this study is to test whether e...

Impaired bidirectional synaptic plasticity in juvenile offspring following prenatal ethanol exposure.

The hippocampus is particularly vulnerable to the teratogenic effects of prenatal ethanol exposure (PNEE), and hippocampal structural and functional deficits are thought to contribute to the learning ...

Medical and Biotech [MESH] Definitions

The prevention of infection or disease following exposure to a pathogen. This is most frequently addressed by administering a vaccine or anti-viral medication following exposure to a virus.

Exposure of the female parent, human or animal, to potentially harmful chemical, physical, or biological agents in the environment or to environmental factors that may include ionizing radiation, pathogenic organisms, or toxic chemicals that may affect offspring. It includes pre-conception maternal exposure.

The health and other ramifications of military and civilian exposure to WAR .

The exposure to potentially harmful chemical, physical, or biological agents by inhaling them.

The exposure to potentially harmful chemical, physical, or biological agents that occurs as a result of one's occupation.

More From BioPortfolio on "Safe Excipient Exposure in Neonates"

Quick Search

Relevant Topics

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

BioPortfolio - life science, medical devices and pharmaceutical conference
BioPortfolio is a leading news, information and knowledge resource covering the global life science industries impacted on by biotechnology. The site aims to provide the lay person, the researcher and the management executive with a single location to so...


Searches Linking to this Trial