Premature InfantNCT05543005
Efficacy Study of an Audio Device Outside Incubator Allowing Broadcasting Maternal Voice on Stability in Preterm Infants
A study testing maternal voice intervention in people with Premature Infant, run by Chia-Jung Lin.
Trial summary
The study aims to evaluate the impact on the preterm infants' short-term physiological, neurodevelopmental states by employing maternal voice intervention in NICU routine care. This study also evaluates the correlation between effective intervention and maternal depression by employing Edinburgh Postnatal Depression… Read more about this study
- Who is it for?
- Ages 28 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Infant
- What is being tested?
- maternal voice intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 31 Jul 2024
- 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 28 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants at 28-36 gestational age
- Within 10 days in NICU after delivery
Who cannot join
- Has a known chromosomal or congenital abnormality
- Major congenital infection
- Brain lesions diagnosed prenatally, or neonatal asphyxia at birth.
- Toxic use by the mother during pregnancy
- Intraventricular hemorrhage of third degree or more occurred in brain ultrasound examination
- Are using sedative medication
- Premature infants use endotracheal tube respirator or high-frequency respirator
- Preterm infants requiring immediate surgical treatment at birth
Trial locations and contacts
No sites are listed yet.
About this study
The study aims to evaluate the impact on the preterm infants' short-term physiological, neurodevelopmental states by employing maternal voice intervention in NICU routine care. This study also evaluates the correlation between effective intervention and maternal depression by employing Edinburgh Postnatal Depression Scale .
Read the detailed description
The study designs a two-arm, double blind randomized control trial (RCT) experiment in terms of a block randomization for allocating participants in experimental and control groups respectively. In the experimental group maternal voice in terms of lullaby, music, and meaningful words plays near the head of premature infant in the incubator by 30 mins each time, and totally three times a day over a 14-days intervention duration. Meanwhile a standard care treats premature infants in the control group. A IntelliVue physiological monitor and a behavior scale collects ECG, respiratory rate, SpO2 concentration, and sleep/awake states of premature infants in both groups. Finally, ANOVA analyzes the statistical significance between the measurer and items.
- Conditions
- Premature Infant
- Being tested
- maternal voice intervention
- Keywords
- premature infant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maternal voice interventionOther
maternal voice in terms of lullaby, music, and meaningful words plays near the head of premature infant in the incubator by 30 mins each time after routine care period
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | maternal voice Receives: Other: maternal voice intervention |
| control group | No intervention | no maternal voice |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
observation at 7th and 14th day after intervention period
Measured: 14th day
respiratory rate
observation at 7th and 14th day after intervention period
Measured: 14th day
SpO2 concentration
observation at 7th and 14th day after intervention period
Measured: 14th day
behavioral status with crying states of premature infants
observation at 7th and 14th day after intervention period
Measured: 14th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study designs a two-arm, double blind randomized control trial (RCT) experiment in terms of a block randomization for allocating participants in experimental and control groups respectively. In the experimental group maternal voice in terms of lullaby, music, and meaningful words plays near the head of premature infant in the incubator by 30 mins each time, and totally three times a day over a 14-days intervention duration. Meanwhile a standard care treats premature infants in the control group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia-Jung Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chia-Jung Lin, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543005
- Sponsor's protocol ID
- 111119-F
- Status last verified
- Sep 2022
- First submitted
- 30 Aug 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of an Audio Device Outside Incubator Allowing Broadcasting Maternal Voice on Stability in Preterm Infants
- ClinicalTrials.gov ID
- NCT05543005
- Acronym / sponsor ID
- 111119-F
- Conditions
- Premature Infant
- Keywords
- premature infant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chia-Jung LinUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 16 Sep 2022 (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 study aims to evaluate the impact on the preterm infants' short-term physiological, neurodevelopmental states by employing maternal voice intervention in NICU routine care. This study also evaluates the correlation between effective intervention and maternal depression by employing Edinburgh Postnatal Depression Scale .
Detailed description
The study designs a two-arm, double blind randomized control trial (RCT) experiment in terms of a block randomization for allocating participants in experimental and control groups respectively. In the experimental group maternal voice in terms of lullaby, music, and meaningful words plays near the head of premature infant in the incubator by 30 mins each time, and totally three times a day over a 14-days intervention duration. Meanwhile a standard care treats premature infants in the control group. A IntelliVue physiological monitor and a behavior scale collects ECG, respiratory rate, SpO2 concentration, and sleep/awake states of premature infants in both groups. Finally, ANOVA analyzes the statistical significance between the measurer and items.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study designs a two-arm, double blind randomized control trial (RCT) experiment in terms of a block randomization for allocating participants in experimental and control groups respectively. In the experimental group maternal voice in terms of lullaby, music, and meaningful words plays near the head of premature infant in the incubator by 30 mins each time, and totally three times a day over a 14-days intervention duration. Meanwhile a standard care treats premature infants in the control group.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: maternal voice interventionmaternal voice |
| control group | No intervention | –no maternal voice |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm infants at 28-36 gestational age
- Within 10 days in NICU after delivery
Key exclusion criteria (8 listed)
- Has a known chromosomal or congenital abnormality
- Major congenital infection
- Brain lesions diagnosed prenatally, or neonatal asphyxia at birth.
- Toxic use by the mother during pregnancy
- Intraventricular hemorrhage of third degree or more occurred in brain ultrasound examination
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 |
|---|---|---|
| maternal voice interventionmaternal voice in terms of lullaby, music, and meaningful words plays near the head of premature infant in the incubator by 30 mins each time after routine care period | Other | experimental group |
Primary outcome
heart rate
Time frame: 14th day
observation at 7th and 14th day after intervention period
respiratory rate
Time frame: 14th day
observation at 7th and 14th day after intervention period
SpO2 concentration
Time frame: 14th day
observation at 7th and 14th day after intervention period
behavioral status with crying states of premature infants
Time frame: 14th day
observation at 7th and 14th day after intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing maternal voice intervention in people with Premature Infant, run by Chia-Jung Lin.
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 2 inclusion and 8 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 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia Jung LIN, master (+886-928185501, chiajung12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate (time frame: 14th day). The study lists 4 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 16 Sep 2022.