Hearing LossAUDIONCT04622059
AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis
A study testing acoustic stimulation in people with Hearing Loss, run by Elena Contro at 1 site in Italy.
Trial summary
The objective of this randomized controlled study was to demonstrate whether fetal hearing can be assessed in utero. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- acoustic stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understand the Italian language;
- Informative consensus;
- To be between 18 and 48 years old;
- To be sure of their gestational age, included between 37 0/0 and 41 5/7 weeks;
- Single fetus pregnancy in cephalic position;
- CTG with normal frequency and variability, without cardiac acceleration for 10 minutes, and with no uterine contractions.
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- Excluding criteria:
- BMI before pregnancy more than 30 kg/m2, and at the end of pregnancy more than 35 kg/m2;
- Uterine fibromatosis;
- Premature rupture of membranes or oligohydramnios;
- Fetal pathology (malformation or genetic syndromes);
- Infective illness contract in pregnancy (CMV, herpes virus, rubella, syphilis, toxoplasmosis);
- Anomalous CTG, or with contractions
- Gestational diabet with insulin therapy;
- 7) Cholestasis of pregnancy; 8) Use of corticosteroids within the last hours; 9) Use of prostaglandins for cervical ripening, within the last hours.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this randomized controlled study was to demonstrate whether fetal hearing can be assessed in utero.
Read the detailed description
Unselected women at term of pregnancy (37-41 weeks of gestation) undergoing cardiotocography (CTG) according to routine clinical care and with a complete postnatal follow-up were consecutively recruited.
The two groups of women were selected in a random way, and it was an unblended randomization controlled trial (RCT), according to a list created by the website ww.randomization.com.
If the CTG was non-reactive for 10 minutes women who were eligible for the study were randomized into two groups.
An auditive stimulus was generated in group A. This stimulus was produced by hitting a diapason on an acoustic surface, at a distance of 2-3 cm from the mother's skin (in order to avoid mechanical vibration to reach the fetus) in the area near the fetus' head.
The same procedure was repeated three times, waiting 30 seconds between one stimulus and the following one. The total duration of stimulation was about 2 minutes. Cardiac accelerations on the CTG and fetal movements perceived by the mother were recorded in the ten minutes after the stimulus was produced.
No stimulation was produced in group B, but the CTG was prosecuted until the clinical criteria were satisfied. The total length of the CTG was variable from a minimum of 20 minutes to a maximum of one hour.
All the clinical variables were recorded in the Case Report Form (CRF) in particular the lapse of time needed for the first fetal cardiac acceleration and for the first fetal movement to occur.
A complete postnatal follow-up was obtained through the examination of medical records and parental interview.
A power analysis was carried out using Power Analysis Sample Size (PASS) software (Kaysville,UT,USA) and was conducted before the enrollment started. It was estimated that, for a survival comparison test (Log Rank), given the sample allocation ratio=1:1, 100 cases per group would be needed to validate a hazard ratio between group A and group B of 1.5 with a power of 80% and a Type I error of 5%.
- Conditions
- Hearing Loss
- Being tested
- acoustic stimulation
- Keywords
- RCT, prenatal testing of hypoacusis
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acoustic stimulationBehavioural
An auditive stimulus was produced by hitting a diapason on an acoustic surface, at a distance of 2-3 cm from the mother's skin (in order to avoid mechanical vibration to reach the fetus) in the area near the fetus' head.
The same procedure was repeated three times, waiting 30 seconds between one stimulus and the following one. The total duration of stimulation was about 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| acoustic stimulation | Experimental | Fetuses in the group A (n=105) received an acoustic stimulation Receives: Behavioral: acoustic stimulation |
| no acoustic stimulation | No intervention | Fetuses in the group B (n=105) no intervention was performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
First alteration of the CTG's reactivity
lapse of time between the acoustic stimulation and the alteration of the CTG's reactivity , the units of measure is minutes
Measured: 40 minutes
First perception of fetal movements by the mother
lapse of time between the acoustic stimulation and the perception of fetal movements by the mother, the units of measure is minutes
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study startSep 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elena Contro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elena Contro, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622059
- Sponsor's protocol ID
- 104/2016/U/Sper
- Acronym
- AUDIO
- Status last verified
- Mar 2021
- First submitted
- 8 Apr 2020
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis
- ClinicalTrials.gov ID
- NCT04622059
- Acronym / sponsor ID
- AUDIO / 104/2016/U/Sper
- Conditions
- Hearing Loss
- Keywords
- RCT, prenatal testing of hypoacusis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Elena ControUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this randomized controlled study was to demonstrate whether fetal hearing can be assessed in utero.
Detailed description
Unselected women at term of pregnancy (37-41 weeks of gestation) undergoing cardiotocography (CTG) according to routine clinical care and with a complete postnatal follow-up were consecutively recruited.
The two groups of women were selected in a random way, and it was an unblended randomization controlled trial (RCT), according to a list created by the website ww.randomization.com.
If the CTG was non-reactive for 10 minutes women who were eligible for the study were randomized into two groups.
An auditive stimulus was generated in group A. This stimulus was produced by hitting a diapason on an acoustic surface, at a distance of 2-3 cm from the mother's skin (in order to avoid mechanical vibration to reach the fetus) in the area near the fetus' head.
The same procedure was repeated three times, waiting 30 seconds between one stimulus and the following one. The total duration of stimulation was about 2 minutes. Cardiac accelerations on the CTG and fetal movements perceived by the mother were recorded in the ten minutes after the stimulus was produced.
No stimulation was produced in group B, but the CTG was prosecuted until the clinical criteria were satisfied. The total length of the CTG was variable from a minimum of 20 minutes to a maximum of one hour.
All the clinical variables were recorded in the Case Report Form (CRF) in particular the lapse of time needed for the first fetal cardiac acceleration and for the first fetal movement to occur.
A complete postnatal follow-up was obtained through the examination of medical records and parental interview.
A power analysis was carried out using Power Analysis Sample Size (PASS) software (Kaysville,UT,USA) and was conducted before the enrollment started. It was estimated that, for a survival comparison test (Log Rank), given the sample allocation ratio=1:1, 100 cases per group would be needed to validate a hazard ratio between group A and group B of 1.5 with a power of 80% and a Type I error of 5%.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acoustic stimulation | Experimental | Behavioral: acoustic stimulationFetuses in the group A (n=105) received an acoustic stimulation |
| no acoustic stimulation | No intervention | –Fetuses in the group B (n=105) no intervention was performed |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Understand the Italian language;
- Informative consensus;
- To be between 18 and 48 years old;
- To be sure of their gestational age, included between 37 0/0 and 41 5/7 weeks;
- Single fetus pregnancy in cephalic position;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acoustic stimulationAn auditive stimulus was produced by hitting a diapason on an acoustic surface, at a distance of 2-3 cm from the mother's skin (in order to avoid mechanical vibration to reach the fetus) in the area near the fetus' head. The same procedure was repeated three times, waiting 30 seconds between one stimulus and the following one. The total duration of stimulation was about 2 minutes. | Behavioural | acoustic stimulation |
Primary outcome
First alteration of the CTG's reactivity
Time frame: 40 minutes
lapse of time between the acoustic stimulation and the alteration of the CTG's reactivity , the units of measure is minutes
First perception of fetal movements by the mother
Time frame: 40 minutes
lapse of time between the acoustic stimulation and the perception of fetal movements by the mother, the units of measure is minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acoustic stimulation in people with Hearing Loss, run by Elena Contro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First alteration of the CTG's reactivity (time frame: 40 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.