Premature BirthNCT02847689
Listening to Mom in the NICU: Neural, Clinical and Language Outcomes
A study testing Language Treatment in people with Premature Birth, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to examine whether playing recordings of a mother's voice to her infant while in the hospital nursery is an effective treatment for promoting healthy brain and language development in infants born preterm. Read more about this study
- Who is it for?
- Ages 24 to 31 weeks
- Conditions the study is for
- Premature Birth
- What is being tested?
- Language Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 1 Oct 2021
- 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 31 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born preterm at Stanford Children's Hospital between 27 0/7 - 31 6/7 weeks gestational age
Who cannot join
- Congenital anomalies
- Recognizable malformation syndromes
- Active seizure disorders
- History of Central Nervous System infections
- Hydrocephalus
- Major sensori-neural hearing loss
Show all 12Show fewer
- Likelihood to be transferred from NICU to alternate care facility or home environment prior to 36 weeks PMA
- Intraventricular Hemorrhage Grades III-IV
- Cystic periventricular leukomalacia (PVL)
- Surgical treatment for necrotizing enterocolitis
- Small for gestational age (SGA) <3 percentile and/or Intra-uterine growth restriction (IUGR) no head sparing
- Twin-to-twin transfusions
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University - Lucile Packard Children's Hospital
Palo Alto, California, 94304
About this study
Official title: Listening to Mom in the Neonatal Intensive Care Unit (NICU): Neural, Clinical and Language Outcomes
The purpose of this study is to examine whether playing recordings of a mother's voice to her infant while in the hospital nursery is an effective treatment for promoting healthy brain and language development in infants born preterm.
Read the detailed description
Children born preterm are at-risk for developmental language delays. Language problems in preterm children are thought to be related to neurobiological factors, including injuries to white matter structures of the brain and environmental factors, including decreased exposure to maternal speech in the hospital nursery. There is evidence to suggest that maternal speech input may be important for promoting healthy brain and language development.
Participants will be randomly assigned to one of two study groups. Each infant has a 50% chance of being assigned to the group that will listen to a recording of his/her mother's voice and a 50% chance of being assigned to the group that will not be played a voice recording. Mother's of participating infants will have her voice recorded as she reads a common children's storybook. Recordings will be played to infants each day until s/he is discharged from the hospital. Participation in this study requires that all infants receive up to an additional 10 minutes of brain scans as part of his/her routine clinical magnetic resonance imaging (MRI).
- Conditions
- Premature Birth
- Being tested
- Language Treatment, Control Treatment
- Keywords
- Premature Birth, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Language TreatmentBehavioural
Recording of a mother's voice reading a children's storybook.
Control TreatmentBehavioural
Also called Standard of Care
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Language Treatment Arm | Experimental | An infant participant randomized to the language treatment arm will be played recordings of his/her mother's voice 2-3 hours daily in the intermediate care nursery until discharge. Receives: Behavioral: Language Treatment |
| Control Treatment Arm | Sham comparator | An infant participant randomized to the control treatment arm will receive standard of care. Standard of care does not include being played recordings of his/her mother's voice while admitted to the intermediate care nursery. However, an infant randomized to the control treatment will have the same auditory equipment placed in his/her isolette or crib as an infant randomized to the Language Treatment Arm. Receives: Behavioral: Control Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
White matter mean diffusivity
Mean diffusivity measures the average rate of water diffusion within a given MRI voxel.
Measured: 36-37 weeks post-menstrual age or at time of hospital discharge, whichever comes first
Secondary outcomes (4)
Length of hospital stay
Days in hospital since birth and until discharge
Measured: Days in hospital since birth and until discharge, average range is 37-40 weeks postmenstrual age (PMA)
Average daily weight gain
Measured: measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA
Time (days) to full oral feed
days until 100 % of nutrition administered orally
Measured: measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA
Number of significant apnea and bradycardia events requiring stimulation
Measured: measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion12 Jun 2019
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Katherine E Travis, PhD, Stanford University
- Investigators
- Katherine E Travis, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847689
- Sponsor's protocol ID
- 32638
- Other IDs
- 1K99HD084749-01A1
- Status last verified
- Oct 2021
- First submitted
- 21 Jul 2016
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Listening to Mom in the Neonatal Intensive Care Unit (NICU): Neural, Clinical and Language Outcomes
- ClinicalTrials.gov ID
- NCT02847689
- Acronym / sponsor ID
- 32638
- Conditions
- Premature Birth
- Keywords
- Premature Birth, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2016
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 28 Jul 2016 (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 study is to examine whether playing recordings of a mother's voice to her infant while in the hospital nursery is an effective treatment for promoting healthy brain and language development in infants born preterm.
Detailed description
Children born preterm are at-risk for developmental language delays. Language problems in preterm children are thought to be related to neurobiological factors, including injuries to white matter structures of the brain and environmental factors, including decreased exposure to maternal speech in the hospital nursery. There is evidence to suggest that maternal speech input may be important for promoting healthy brain and language development.
Participants will be randomly assigned to one of two study groups. Each infant has a 50% chance of being assigned to the group that will listen to a recording of his/her mother's voice and a 50% chance of being assigned to the group that will not be played a voice recording. Mother's of participating infants will have her voice recorded as she reads a common children's storybook. Recordings will be played to infants each day until s/he is discharged from the hospital. Participation in this study requires that all infants receive up to an additional 10 minutes of brain scans as part of his/her routine clinical magnetic resonance imaging (MRI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Language Treatment Arm | Experimental | Behavioral: Language TreatmentAn infant participant randomized to the language treatment arm will be played recordings of his/her mother's voice 2-3 hours daily in the intermediate care nursery until discharge. |
| Control Treatment Arm | Sham comparator | Behavioral: Control TreatmentAn infant participant randomized to the control treatment arm will receive standard of care. Standard of care does not include being played recordings of his/her mother's voice while admitted to the intermediate care nursery. However, an infant randomized to the control treatment will have the same auditory equipment placed in his/her isolette or crib as an infant randomized to the Language Treatment Arm. |
Who may qualify
- Ages
- 24 to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants born preterm at Stanford Children's Hospital between 27 0/7 - 31 6/7 weeks gestational age
Key exclusion criteria (12 listed)
- Congenital anomalies
- Recognizable malformation syndromes
- Active seizure disorders
- History of Central Nervous System infections
- Hydrocephalus
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 |
|---|---|---|
| Language TreatmentRecording of a mother's voice reading a children's storybook. | Behavioural | Language Treatment Arm |
| Control TreatmentAlso: Standard of CareStandard of Care | Behavioural | Control Treatment Arm |
Primary outcome
White matter mean diffusivity
Time frame: 36-37 weeks post-menstrual age or at time of hospital discharge, whichever comes first
Mean diffusivity measures the average rate of water diffusion within a given MRI voxel.
4 secondary outcomes
Length of hospital stay
Time frame: Days in hospital since birth and until discharge, average range is 37-40 weeks postmenstrual age (PMA)
Average daily weight gain
Time frame: measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA
Time (days) to full oral feed
Time frame: measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA
Number of significant apnea and bradycardia events requiring stimulation
Time frame: measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA
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 4 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
Katherine E Travis, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Language Treatment in people with Premature Birth, run by Stanford University 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 12 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 4 Nov 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 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?
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?
White matter mean diffusivity (time frame: 36-37 weeks post-menstrual age or at time of hospital discharge, whichever comes first). 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 4 Nov 2021.