Preterm BirthNCT01913288
Effects of Mother's Voice and Heartbeat Sounds on Preterm Newborns
A study testing Biological Maternal Sounds in people with Preterm Birth, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this RCT is to learn more about how sounds that we experience in the womb can affect early development in premature infants. The investigators are specifically interested determining whether and what types of maternal sensory stimulation can influence physical growth, brain maturation, respiratory… Read more about this study
- Who is it for?
- Ages 24 to 34 weeks
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Biological Maternal Sounds
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Dec 2019
- 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 24 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born between 24-36 weeks GA.
Who cannot join
- Chromosomal or congenital anomalies; congenital infections; > grade II IVH;
- maternal use of tobacco, alcohol, or illicit drugs;
- significant abuse or malnutrition during pregnancy,
- failed ABR.
- No exclusions based on gender or ethnicity.
Trial locations and contacts
1 site in 1 country.
Amir Lahav, ScD contact
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Paul Hughes, phughes@partners.org
Amir Lahav, ScD
About this study
Official title: Exposure to Biological Maternal Sounds in Extremely Preterm Infants: Effects on Short- and Long-term Outcomes
The purpose of this RCT is to learn more about how sounds that we experience in the womb can affect early development in premature infants. The investigators are specifically interested determining whether and what types of maternal sensory stimulation can influence physical growth, brain maturation, respiratory stability and early vocalization during postnatal development. The investigators hypothesize that daily exposure to biological maternal sounds, such as mother's voice and heartbeat, will improve both short-term and long-term developmental in premature infants and will increase their potential to grow into healthy children.
Read the detailed description
The purpose of this RCT is to learn more about how sounds that we experience in the womb can affect early development in premature infants. The investigators are specifically interested determining whether and what types of maternal auditory stimulation can influence physical growth, brain maturation, respiratory stability (including heart rate, respiratory rate and oxygen saturation levels) as well as early vocalization prior to 40 weeks gestation. The investigators hypothesize that daily exposure to biological maternal sounds, such as mother's voice and heartbeat, will improve both short-term and long-term developmental outcomes in premature infants and will increase their potential to grow into healthy children.
- Conditions
- Preterm Birth
- Being tested
- Biological Maternal Sounds
- Keywords
- neonatal care, preterm, maternal sounds, auditory stimulation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological Maternal SoundsOther
| Study group | Role | What they receive |
|---|---|---|
| Biological Maternal Sounds | Experimental | Daily Exposure to recorded mother's voice and heartbeat sounds via audio systems installed at the bedside Receives: Other: Biological Maternal Sounds |
| Hospital Sounds | Sham comparator | Exposure to standard hospital sounds; routine care. Receives: Other: Biological Maternal Sounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain volume (DM^3)
Data will be obtained by an MRI brain scan and will be calculated separately for white matter, grey matter, CSF.
Measured: Between 36-40 weeks gestation
Language and cognitive skills
Data will be obtained using the MacArthur-Bates Communicative Development Inventories (CDI), the Receptive-Expressive Emergent Language Test Third Edition (REEL-3), and the Bayley Scales of Infant Development Third Edition (Bayley-III).
Measured: At 12 and 24 months corrected-age
Secondary outcomes (4)
Oxygen saturation levels (mg/l)
Data will be collected from the bedside cardiac monitor
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Heart rate (BPM)
Data will be collected from the bedside cardiac monitor
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Infant vocalization (word count)
Data will be obtained by real-time recording of the language environment
Measured: Between 32-36 weeks gesation
Weight gain (gr/kg/day)
Data will be obtained from medical records
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Charles H. Hood Foundation, Peter and Elizabeth C. Tower Foundation
- Responsible party
- Principal investigator, Amir Lahav, Brigham and Women's Hospital
- Investigators
- Amir Lahav, ScD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913288
- Sponsor's protocol ID
- 2009p000936
- Status last verified
- Jul 2013
- First submitted
- 16 May 2013
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure to Biological Maternal Sounds in Extremely Preterm Infants: Effects on Short- and Long-term Outcomes
- ClinicalTrials.gov ID
- NCT01913288
- Acronym / sponsor ID
- 2009p000936
- Conditions
- Preterm Birth
- Keywords
- neonatal care, preterm, maternal sounds, auditory stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Charles H. Hood Foundation, Peter and Elizabeth C. Tower Foundation
- Study start
- May 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 Aug 2013 (estimated)
- 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 purpose of this RCT is to learn more about how sounds that we experience in the womb can affect early development in premature infants. The investigators are specifically interested determining whether and what types of maternal sensory stimulation can influence physical growth, brain maturation, respiratory stability and early vocalization during postnatal development. The investigators hypothesize that daily exposure to biological maternal sounds, such as mother's voice and heartbeat, will improve both short-term and long-term developmental in premature infants and will increase their potential to grow into healthy children.
Detailed description
The purpose of this RCT is to learn more about how sounds that we experience in the womb can affect early development in premature infants. The investigators are specifically interested determining whether and what types of maternal auditory stimulation can influence physical growth, brain maturation, respiratory stability (including heart rate, respiratory rate and oxygen saturation levels) as well as early vocalization prior to 40 weeks gestation. The investigators hypothesize that daily exposure to biological maternal sounds, such as mother's voice and heartbeat, will improve both short-term and long-term developmental outcomes in premature infants and will increase their potential to grow into healthy children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological Maternal Sounds | Experimental | Other: Biological Maternal SoundsDaily Exposure to recorded mother's voice and heartbeat sounds via audio systems installed at the bedside |
| Hospital Sounds | Sham comparator | Other: Biological Maternal SoundsExposure to standard hospital sounds; routine care. |
Who may qualify
- Ages
- 24 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Born between 24-36 weeks GA.
Key exclusion criteria (5 listed)
- Chromosomal or congenital anomalies; congenital infections; > grade II IVH;
- maternal use of tobacco, alcohol, or illicit drugs;
- significant abuse or malnutrition during pregnancy,
- failed ABR.
- No exclusions based on gender or ethnicity.
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 |
|---|---|---|
| Biological Maternal Sounds | Other | Biological Maternal Sounds, Hospital Sounds |
Primary outcome
Brain volume (DM^3)
Time frame: Between 36-40 weeks gestation
Data will be obtained by an MRI brain scan and will be calculated separately for white matter, grey matter, CSF.
Language and cognitive skills
Time frame: At 12 and 24 months corrected-age
Data will be obtained using the MacArthur-Bates Communicative Development Inventories (CDI), the Receptive-Expressive Emergent Language Test Third Edition (REEL-3), and the Bayley Scales of Infant Development Third Edition (Bayley-III).
4 secondary outcomes
Oxygen saturation levels (mg/l)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Heart rate (BPM)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Infant vocalization (word count)
Time frame: Between 32-36 weeks gesation
Weight gain (gr/kg/day)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2013.
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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.
Amir Lahav, ScD contact
Amir Lahav, ScD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological Maternal Sounds in people with Preterm Birth, run by Brigham and Women's Hospital at 1 site in United States.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Aug 2013. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Lahav, ScD (amir@hms.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain volume (DM^3) (time frame: Between 36-40 weeks gestation). 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 1 Aug 2013.