Condition category
Not Applicable
Date applied
06/03/2012
Date assigned
28/05/2012
Last edited
14/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Medicines contain active pharmaceutical ingredients along with a range of other chemicals, collectively known as excipients. These excipients are required to overcome the chemical, physical and microbiological issues that occur when developing formulations that are of good quality to be used in clinical practice. Extensive work is done by pharmaceutical companies to ensure that excipients are safe, which requires knowledge about exposure and outcomes. Premature babies are a vulnerable group as they are not yet suited to life outside of the uterus and can become seriously ill as they adapt to birth, therefore they are often given multiple medications to help them. This may also be the case for full-term babies who are seriously unwell, for example with infections. Nobody has measured the levels of excipients used in medicines for babies and although we are happy with those currently used in clinical practice, it would help to know more about how the body handles the excipients currently used. It would also help pharmacists when developing new medicines for use in babies to ensure that only chemicals that are necessary are included in the formulations. The main aim of the study is to measure the concentration of selected excipient in blood samples taken from newborn babies.

Who can participate?
Treatment, or likely treatment, of neonates with a drug prescribed containing any of the following excipients; Propylene Glycol, Ethanol and metabolites (Fatty acid ethyl esters are no-oxidative ehtanol metabolities), Propylhydroxybenzoate and other parabens, sodium benzoate/benzoic acid/benzyl alcohol, Polysorbate 80, Sorbitol. Each neonatal unit will develop a list of medicines containing the excipient which will trigger eligibility to the study.

What does the study involve?
This is an observational study of routine clinical practice in which clinical data will be supplemented by information from blood samples taken opportunistically or during specific sampling periods.

What are the possible benefits and risks of participating?
There is no expected direct benefit to participants and no risks.

Where is the study run from?
Liverpool Women's NHS Foundation Trust

When is the study starting and how long is it expected to run for?
October 2011 to December 2012

Who is funding the study?
Medical Research Council (MRC), UK

Who is the main contact?
Ms Susan Graham
susan.graham@lwh.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Susan Graham

ORCID ID

Contact details

Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
-
susan.graham@lwh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11663

Study information

Scientific title

European Study of Neonatal Excipient Exposure (ESNEE): an observational study of excipient kinetics in neonates

Acronym

ESNEE

Study hypothesis

Medicines contain drugs (active pharmaceutical ingredients) along with a range of other chemicals, collectively known as excipients. These excipients are required to overcome the chemical, physical and microbiological issues that occur when developing formulations that are of good enough quality to be used in clinical practice.

Extensive work is done by pharmaceutical companies to ensure that excipients are safe in adults. Nobody has measured the levels of excipients used in medicines for babies so that it is not possible at present to make robust evaluations of excipient safety, particularly in newborn babies. Although clinicians are happy with those currently used in clinical practice, it would help to know more about how the body handles the excipients currently used. It would also help pharmacists when developing new medicines for use in babies to know how the body deals with excipients.

This study will look at a selection of excipients and measure how much of these excipients get into the blood stream and how long those excipients stay in the blood stream of newborn babies. The selected excipients will serve as case studies to describe what happens to important excipients and to define the best ways to measure excipients in newborn babies.

More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=11663

Ethics approval

NRES Committee North West - Greater Manchester, 14/10/2011, ref: 11/NW/0665

Study design

Observational case-controlled study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please contact susan.graham@lwh.nhs.uk to request a patient information sheet

Condition

Medicines for neonates

Intervention

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 consented to allow extra blood samples to be taken from their child, a maximum of 10 extra samples will be taken at specific time points.

Where parents consent to only allow for blood to be taken as part of routine clinical practice, any excess blood will be used instead of being discarded. The day of the last sample will be when 10 extra samples have been obtained or when the baby is transferred to a unit which is not collecting samples for the study.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

No secondary outcome measures

Overall trial start date

01/11/2011

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

Planned Sample Size: 1300; UK Sample Size: 500

Participant 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

Recruitment start date

01/11/2011

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Estonia, France, United Kingdom

Trial participating centre

Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom

Sponsor information

Organisation

Liverpool Women's NHS Foundation Trust (UK)

Sponsor details

Neonatal Unit
Liverpool Womens Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) ref: G1100158 - Lifelong Health and Wellbeing

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/12/2015: no publications found on PubMed.