Medicines for neonates Not Applicable
Conditions
Interventions
Parents will be asked to consent to allow their baby to participate in the study in advance of them being prescribed one of the medicines that contain the excipient of interest.
Where parents have co
Sponsors
Liverpool Women's NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Treatment, or likely treatment, of neonates with a drug prescribed containing any of the following excipients: 1. Propylene glycol 2. Ethanol and metabolites [Fatty acid ethyl esters (FAEEs) are nonoxidative ethanol metabolites] 3. Propylhydroxybenzoate and other parabens 4. Sodium benzoate/benzoic acid/ benzyl alcohol 5. Polysorbate 80 6. Sorbitol Each neonatal unit will develop a list of medicines containing the excipient which will trigger eligibility to the study. An example list of the drugs prescribed in the lead UK neonatal unit which contain the excipients can be provided on request to the study coordinator.
Exclusion criteria
Exclusion criteria: 1. Babies whose mothers refuse to give consent 2. Babies whose mothers are deemed too poorly or not competent to give valid consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To develop pilot excipient kinetic models to indicate how much of each selected excipient is in the bloodstream of babies who have been given medicines containing those excipients | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Estonia, France, United Kingdom
Outcome results
None listed