Gentamicin, genetic variation and deafness in preterm children
| ISRCTN | ISRCTN39982239 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39982239 |
| Secondary identifying numbers | ISRCTNRNIDG47 |
- Submission date
- 19/12/2013
- Registration date
- 18/02/2014
- Last edited
- 28/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English Summary
Background and study aims
Acquired hearing loss is a hearing loss that appears after birth. It occurs ten times more often in infants born before 32 weeks of gestation (very preterm). There are several possible causes, including the side effects of some regularly used medications on neonatal units, such as aminoglycosides. These are known to have effects on the hearing system but, despite being at high risk of receiving aminoglycosides, there is little evidence for drug-induced damage to the inner ear in preterm children. The risk of hearing loss may be increased further in babies with the DNA mutation m.1555A>G. Patients with this mutation who receive aminoglycosides suffer from hearing loss even when drug levels are maintained within normal limits; this effect may be reduced in the newborn period, but this has not been formally studied. The aim of this study is to look at the relationship between the m.1555A>G mutation, aminoglycosides and deafness in children born very prematurely.
Who can participate?
Deaf children and children with normal hearing who were born at 31 weeks and 6 days of gestation or less
What does the study involve?
Saliva samples are taken from children in both groups for genetic analysis of m.1555A>G. Clinical data including information on aminoglycoside exposure is taken from medical notes.
What are the possible benefits and risks of participating?
The main benefit to participants with deafness is the opportunity to find the cause of their hearing loss. If the child has the mutation, it is likely that this is the cause. There is little benefit for participants who have normal hearing, but if they test positive for the mutation they are advised to avoid aminoglycoside antibiotics in the future to prevent the risk of hearing loss. There are no anticipated risks for participants, although children could be nervous about having a saliva sample taken.
Where is the study run from?
University College London (UK)
When is the study starting and how long is it expected to run for?
January 2013 to January 2016
Who is funding the study?
Action on Hearing Loss (UK)
Who is the main contact?
1. Prof. Maria Bitner-Glindzicz (maria.bitner@ucl.ac.uk)
2. Prof. Neil Marlow (n.marlow@ucl.ac.uk)
Contact information
Scientific
30 Guilford Street
London
WC1N 1EH
United Kingdom
 ORCID ID |
0000-0003-4639-8336 |
|---|
Study information
| Study design | Case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | http://www.ucl.ac.uk/mitogent/documents |
| Scientific title | Gentamicin, genetic variation and deafness in preterm children: a case-control study |
| Study acronym | MitoGent |
| Study hypothesis | The hypothesis is that mutation (m.1555A>G) makes a significant contribution to deafness in babies born at 31 weeks and 6 days of gestation or less who receive treatment with aminoglycosides, even when drug levels were within the normal range. |
| Ethics approval(s) | NRES Ethics Committee London - Central, 02/02/2012, ref: 12/LO/0005 |
| Condition | Hearing loss in preterm infants |
| Intervention | This is an observational study which will only involve saliva samples and access to medical notes. Children with hearing loss will be invited to participate by their audiological paediatrician; ex-preterm children with normal hearing will be invited by their neonatologist. Saliva samples will be taken from children in both groups for genetic analysis of m.1555A>G. Clinical data including information on aminoglycoside exposure will be abstracted from medical notes. |
| Intervention type | Other |
| Primary outcome measure | Prevalence of the m.1555A>G mutation, measured using saliva samples tested for the mutation by direct DNA sequencing |
| Secondary outcome measures | Gentamicin administration, measured using data from medical notes |
| Overall study start date | 27/01/2013 |
| Overall study end date | 27/01/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 30 - 60 deaf children and 5 controls per deaf baby/child. Total 150-300 children |
| Participant inclusion criteria | Cases: babies born at 31 weeks and 6 days gestational age or less with hearing loss, treated on a neonatal unit within Greater London between 01/01/2009 - 31/12/2013 Controls: babies born at 31 weeks and 6 days gestational age or less with normal hearing, treated on a neonatal unit within Greater London between 01/01/2009 - 31/12/2013 |
| Participant exclusion criteria | Cases: no exclusion criteria Controls: missing data in medication records |
| Recruitment start date | 27/01/2013 |
| Recruitment end date | 27/01/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
WC1N 1EH
United Kingdom
Sponsor information
University/education
30 Guilford Street
London
WC1N 1EH
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The trialists intend to publish in 2017. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
28/05/2019: Internal review.
