Condition category
Ear, Nose and Throat
Date applied
19/12/2013
Date assigned
18/02/2014
Last edited
03/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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)

Trial website

http://www.ucl.ac.uk/mitogent

Contact information

Type

Scientific

Primary contact

Prof Maria Bitner-Glindzicz

ORCID ID

http://orcid.org/0000-0003-4639-8336

Contact details

30 Guilford Street
London
WC1N 1EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ISRCTNRNIDG47

Study information

Scientific title

Gentamicin, genetic variation and deafness in preterm children: a case-control 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

NRES Ethics Committee London -– Central, 02/02/2012, ref: 12/LO/0005

Study design

Case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

http://www.ucl.ac.uk/mitogent/documents

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

Phase

Drug names

Primary outcome measures

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 trial start date

27/01/2013

Overall trial end date

27/01/2016

Reason abandoned

Eligibility

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 type

Patient

Age group

Neonate

Gender

Both

Target number of participants

30 -– 60 deaf children and 5 controls per deaf baby/child. Total 150-300 children

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

United Kingdom

Trial participating centre

University College London - Institute of Child Health
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

University College London - Institute of Child Health (UK)

Sponsor details

30 Guilford Street
London
WC1N 1EH
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Action on Hearing Loss (UK) (ref: RNID G47)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

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.

Intention to publish date

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes