PretermNCT07068581
Effect of Maternal Voice on Physiological Indicators and Feeding Performance
A study testing Maternal voice in people with Preterm and Oral Feeding Performance, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effect of maternal voice on physiological indicators and oral feeding performance in preterm infants. Hypothesis 1 (H1): Preterm infants who listen to their mother's voice throughout the full oral feeding process have higher oxygen saturation levels than those who do not. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Preterm, Oral Feeding Performance
- What is being tested?
- Maternal voice
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2025to 12 Jun 2026
- 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 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants born at gestational age ≥28 weeks and ≤34 weeks
- Infants who are ≥30 postmenstrual weeks old at the time of enrollment
- Infants weighing ≥1000 grams at the time of enrollment
- Mothers aged 18 years or older
- Preterm infants who have passed the hearing screening test
- Infants whose mothers can provide an average of at least 30 ml of expressed breast milk daily during the study period.
- Mothers who are Turkish speakers.
- Infants for whom the decision to transition from enteral feeding to full oral feeding has been made for the first time jointly by the physician and nurse
Who cannot join
- Preterm infants with congenital anomalies.
- Infants with a family history of congenital hearing loss.
- Infants diagnosed with intraventricular hemorrhage (grade 3-4) or -periventricular leukomalacia.
- Infants who have had necrotizing enterocolitis requiring treatment.
- Infants whose mothers have a history of substance abuse or alcoholism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Maternal Voice on Physiological Indicators and Feeding Performance During Full Oral Feeding Transition in Preterm Infants: A Randomized Controlled Trial
This study aimed to determine the effect of maternal voice on physiological indicators and oral feeding performance in preterm infants.
Hypothesis 1 (H1): Preterm infants who listen to their mother's voice throughout the full oral feeding process have higher oxygen saturation levels than those who do not.
Read more
Hypothesis 2 (H2): Preterm infants who listen to their mother's voice throughout the full oral feeding process have lower heart rates than those who do not.
Hypothesis 3 (H3): Preterm infants exposed to maternal voice throughout the full oral feeding process have lower respiratory rates than those who are not exposed.
Hypothesis 4 (H4): Preterm infants exposed to maternal voice throughout the full oral feeding process have better feeding maturation than those who are not exposed.
Hypothesis 5 (H5): The percentage of nutrient intake in preterm infants exposed to maternal voice throughout the entire oral feeding process is higher than in those not exposed.
Hypothesis 6 (H6): The feeding time of preterm infants exposed to the mother's voice throughout the entire oral feeding process is shorter than that of those not exposed.
Hypothesis 7 (H7): The amount of food consumed per minute by preterm infants exposed to the mother's voice throughout the entire oral feeding process is greater than that of those not exposed.
Read the detailed description
Oral feeding is one of the critical milestones in the growth and development of preterm infants. A delay in achieving successful oral feeding skills may lead to prolonged hospitalization, negatively impact mother-infant bonding, result in long-term feeding difficulties, impair growth and development, and cause adverse neurodevelopmental outcomes. The literature reports that various methods have been used to enhance oral feeding performance, one of which is maternal voice. It has been reported that the maternal voice has a positive effect on the oral feeding performance of preterm infants. Continuing maternal vocal stimulation during the postnatal period (such as singing lullabies, reading books, or engaging in everyday speech) contributes to strengthening synaptic connections in the auditory cortex, increasing the brain's sensory processing capacity, reducing the infant's stress levels, and maintaining physiological stability. The maternal voice positively influences oral feeding performance by helping infants maintain an alert state and facilitating the coordination of sucking, swallowing, and breathing. In this regard, the maternal voice can be used as an evidence-based nursing intervention to enrich the care of preterm infants. However, the number of high-level evidence studies investigating the relationship between maternal voice and oral feeding performance is limited in the literature, and some existing studies report inconclusive results. Therefore, addressing this issue will help fill a gap in the literature.
In this study, preterm infants in the experimental group will listen to a lullaby recorded in their own mother's voice before and during oral feeding, twice daily (morning and evening) for five consecutive days. A Bluetooth-enabled, speaker-equipped voice recorder will be used for each infant individually. No auditory intervention will be applied to the infants in the control group. In both groups, physiological indicators and oral feeding performance will be measured on specific days.
- Conditions
- Preterm, Oral Feeding Performance
- Being tested
- Maternal voice, Control Group (standard feeding )
- Keywords
- Preterm infants, Oral feeding performance, Maternal voice, NICU care
- 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 voiceProcedure or surgery
Mothers of the infants in the intervention group will be asked to read aloud the lyrics of a designated in a calm tone of voice in a quiet environment, and their voices will be recorded. The recorded maternal voice will then be played to the infants in the NICU using the same Bluetooth-enabled device with built-in speakers. The audio device will be placed inside the incubator or open warmer, approximately 20-30 cm from the infant.
Each infant will be assigned an individual audio device, which will be used exclusively for that infant. Maternal voice playback will begin 20 minutes before morning and evening oral feedings and will continue throughout the feeding session, twice daily, for a maximum of 5 days. If the infant is discharged earlier, the intervention will be discontinued.. During the playback of the maternal voice, monitor sounds in the NICU will be minimized, and the staff will be instructed to speak quietly to maintain a calm environment.
Control Group (standard feeding )Other
The control group will not be exposed to maternal voice, and standard feeding procedures will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Maternal voice group | Experimental | The maternal voice will be played twice daily, starting 20 minutes before the morning and evening oral feedings and continuing throughout the feeding session. Receives: Procedure: Maternal voice |
| Standard feeding group | Other | This group will not be exposed to maternal voice before or during feeding; standard feeding care will be provided. Receives: Other: Control Group (standard feeding ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oral Feeding Performance
Oral feeding performance will be measured using the 'Oral Feeding Maturation Monitoring Device.' One of the device's sensors is positioned under the infant's chin, and the other is placed on the chest. The device evaluates the infant's sucking-swallowing-breathing coordination during a 2-minute feeding session.
Measured: The first day the infant transitions to full oral feeding and the 5th day will be evaluated. The change between these time points will be assessed.
Change in oxygen saturation
Preterm infant will be monitored and oxygen saturation will be monitored.
Measured: Oxygen saturation will be measured once daily for five days. Data will be collected immediately before, during, immediately after feeding. The change in these time intervals will be assessed.
Change in heart rate
Preterm infant will be monitored and heart rate will be monitored.
Measured: Heart rate will be measured once daily for five days. Data will be collected immediately before, during, immediately after feeding. The change in these time intervals will be assessed.
Change in respiratory rate
Preterm infant will be monitored and respiratory rate will be monitored.
Measured: Respiratory rate will be measured once daily for five days. Data will be collected immediately before, during, immediately after feeding. The change in these time intervals will be assessed.
Change in Oral Feeding Skills
Change in oral feeding skills will be assessed using the Early Feeding Skills Assessment Scale.
The scale was originally developed in 2005, and its Turkish validity and reliability were established in 2021.
It consists of 5 subdimensions and a total of 19 items. Each item is rated on a scale from 1 to 3. The total score ranges from 19 to 57, with higher scores indicating more advanced feeding skills.
Measured: The first day the infant transitions to full oral feeding and the 5th day will be evaluated. The change between these time points will be assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start10 Aug 2025
- Primary completion12 Jun 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Acibadem 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semra Küçük, Acibadem University
- Investigators
- Semra Küçük, Research Assistant,Phd Student, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068581
- Sponsor's protocol ID
- ATADEK-2025/09
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamm EL, Chorna OD, Stark AR, Maitre NL. Feeding outcomes and parent perceptions after the pacifier-activated music player with mother's voice trial. Acta Paediatr. 2015 Aug;104(8):e372-4. doi: 10.1111/apa.13030. Epub 2015 May 16. No abstract available.
PubMed 25892736Chorna OD, Slaughter JC, Wang L, Stark AR, Maitre NL. A pacifier-activated music player with mother's voice improves oral feeding in preterm infants. Pediatrics. 2014 Mar;133(3):462-8. doi: 10.1542/peds.2013-2547. Epub 2014 Feb 17.
PubMed 24534413Chirico G, Cabano R, Villa G, Bigogno A, Ardesi M, Dioni E. Randomised study showed that recorded maternal voices reduced pain in preterm infants undergoing heel lance procedures in a neonatal intensive care unit. Acta Paediatr. 2017 Oct;106(10):1564-1568. doi: 10.1111/apa.13944. Epub 2017 Jul 5.
PubMed 28580602Chhikara A, Hagadorn JI, Lainwala S. Effect of maternal voice on proportion of oral feeding in preterm infants. J Perinatol. 2023 Jan;43(1):68-73. doi: 10.1038/s41372-022-01493-4. Epub 2022 Aug 18.
PubMed 35982244Alabbasi Y, Parker L, Weaver M, Krueger C. Maternal Voice Exposure and Its Effect on Premature Infants' Feeding Milestones: A Systematic Review. Adv Neonatal Care. 2023 Apr 1;23(2):E40-E49. doi: 10.1097/ANC.0000000000001029. Epub 2022 Oct 3.
PubMed 36191331
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maternal Voice on Physiological Indicators and Feeding Performance During Full Oral Feeding Transition in Preterm Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07068581
- Acronym / sponsor ID
- ATADEK-2025/09
- Conditions
- Preterm, Oral Feeding Performance
- Keywords
- Preterm infants, Oral feeding performance, Maternal voice, NICU care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 12 Jun 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 16 Jul 2025 (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.
This study aimed to determine the effect of maternal voice on physiological indicators and oral feeding performance in preterm infants.
Hypothesis 1 (H1): Preterm infants who listen to their mother's voice throughout the full oral feeding process have higher oxygen saturation levels than those who do not.
Hypothesis 2 (H2): Preterm infants who listen to their mother's voice throughout the full oral feeding process have lower heart rates than those who do not.
Hypothesis 3 (H3): Preterm infants exposed to maternal voice throughout the full oral feeding process have lower respiratory rates than those who are not exposed.
Hypothesis 4 (H4): Preterm infants exposed to maternal voice throughout the full oral feeding process have better feeding maturation than those who are not exposed.
Hypothesis 5 (H5): The percentage of nutrient intake in preterm infants exposed to maternal voice throughout the entire oral feeding process is higher than in those not exposed.
Hypothesis 6 (H6): The feeding time of preterm infants exposed to the mother's voice throughout the entire oral feeding process is shorter than that of those not exposed.
Hypothesis 7 (H7): The amount of food consumed per minute by preterm infants exposed to the mother's voice throughout the entire oral feeding process is greater than that of those not exposed.
Detailed description
Oral feeding is one of the critical milestones in the growth and development of preterm infants. A delay in achieving successful oral feeding skills may lead to prolonged hospitalization, negatively impact mother-infant bonding, result in long-term feeding difficulties, impair growth and development, and cause adverse neurodevelopmental outcomes. The literature reports that various methods have been used to enhance oral feeding performance, one of which is maternal voice. It has been reported that the maternal voice has a positive effect on the oral feeding performance of preterm infants. Continuing maternal vocal stimulation during the postnatal period (such as singing lullabies, reading books, or engaging in everyday speech) contributes to strengthening synaptic connections in the auditory cortex, increasing the brain's sensory processing capacity, reducing the infant's stress levels, and maintaining physiological stability. The maternal voice positively influences oral feeding performance by helping infants maintain an alert state and facilitating the coordination of sucking, swallowing, and breathing. In this regard, the maternal voice can be used as an evidence-based nursing intervention to enrich the care of preterm infants. However, the number of high-level evidence studies investigating the relationship between maternal voice and oral feeding performance is limited in the literature, and some existing studies report inconclusive results. Therefore, addressing this issue will help fill a gap in the literature.
In this study, preterm infants in the experimental group will listen to a lullaby recorded in their own mother's voice before and during oral feeding, twice daily (morning and evening) for five consecutive days. A Bluetooth-enabled, speaker-equipped voice recorder will be used for each infant individually. No auditory intervention will be applied to the infants in the control group. In both groups, physiological indicators and oral feeding performance will be measured on specific days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maternal voice group | Experimental | Procedure: Maternal voiceThe maternal voice will be played twice daily, starting 20 minutes before the morning and evening oral feedings and continuing throughout the feeding session. |
| Standard feeding group | Other | Other: Control Group (standard feeding )This group will not be exposed to maternal voice before or during feeding; standard feeding care will be provided. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Preterm infants born at gestational age ≥28 weeks and ≤34 weeks
- Infants who are ≥30 postmenstrual weeks old at the time of enrollment
- Infants weighing ≥1000 grams at the time of enrollment
- Mothers aged 18 years or older
- Preterm infants who have passed the hearing screening test
Key exclusion criteria (5 listed)
- Preterm infants with congenital anomalies.
- Infants with a family history of congenital hearing loss.
- Infants diagnosed with intraventricular hemorrhage (grade 3-4) or -periventricular leukomalacia.
- Infants who have had necrotizing enterocolitis requiring treatment.
- Infants whose mothers have a history of substance abuse or alcoholism
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 voiceMothers of the infants in the intervention group will be asked to read aloud the lyrics of a designated in a calm tone of voice in a quiet environment, and their voices will be recorded. The recorded maternal voice will then be played to the infants in the NICU using the same Bluetooth-enabled device with built-in speakers. The audio device will be placed inside the incubator or open warmer, approximately 20-30 cm from the infant. Each infant will be assigned an individual audio device, which will be used exclusively for that infant. Maternal voice playback will begin 20 minutes before morning and evening oral feedings and will continue throughout the feeding session, twice daily, for a maximum of 5 days. If the infant is discharged earlier, the intervention will be discontinued.. During the playback of the maternal voice, monitor sounds in the NICU will be minimized, and the staff will be instructed to speak quietly to maintain a calm environment. | Procedure or surgery | Maternal voice group |
| Control Group (standard feeding )The control group will not be exposed to maternal voice, and standard feeding procedures will be applied. | Other | Standard feeding group |
Primary outcome
Change in Oral Feeding Performance
Time frame: The first day the infant transitions to full oral feeding and the 5th day will be evaluated. The change between these time points will be assessed.
Oral feeding performance will be measured using the 'Oral Feeding Maturation Monitoring Device.' One of the device's sensors is positioned under the infant's chin, and the other is placed on the chest. The device evaluates the infant's sucking-swallowing-breathing coordination during a 2-minute feeding session.
Change in oxygen saturation
Time frame: Oxygen saturation will be measured once daily for five days. Data will be collected immediately before, during, immediately after feeding. The change in these time intervals will be assessed.
Preterm infant will be monitored and oxygen saturation will be monitored.
Change in heart rate
Time frame: Heart rate will be measured once daily for five days. Data will be collected immediately before, during, immediately after feeding. The change in these time intervals will be assessed.
Preterm infant will be monitored and heart rate will be monitored.
Change in respiratory rate
Time frame: Respiratory rate will be measured once daily for five days. Data will be collected immediately before, during, immediately after feeding. The change in these time intervals will be assessed.
Preterm infant will be monitored and respiratory rate will be monitored.
Change in Oral Feeding Skills
Time frame: The first day the infant transitions to full oral feeding and the 5th day will be evaluated. The change between these time points will be assessed.
Change in oral feeding skills will be assessed using the Early Feeding Skills Assessment Scale. The scale was originally developed in 2005, and its Turkish validity and reliability were established in 2021. It consists of 5 subdimensions and a total of 19 items. Each item is rated on a scale from 1 to 3. The total score ranges from 19 to 57, with higher scores indicating more advanced feeding skills.
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 6 Jul 2026.
- Background: PubMed 25892736Hamm EL, Chorna OD, Stark AR, Maitre NL. Feeding outcomes and parent perceptions after the pacifier-activated music player with mother's voice trial. Acta Paediatr. 2015 Aug;104(8):e372-4. doi: 10.1111/apa.13030. Epub 2015 May 16. No abstract available.
- Background: PubMed 24534413Chorna OD, Slaughter JC, Wang L, Stark AR, Maitre NL. A pacifier-activated music player with mother's voice improves oral feeding in preterm infants. Pediatrics. 2014 Mar;133(3):462-8. doi: 10.1542/peds.2013-2547. Epub 2014 Feb 17.
- Background: PubMed 28580602Chirico G, Cabano R, Villa G, Bigogno A, Ardesi M, Dioni E. Randomised study showed that recorded maternal voices reduced pain in preterm infants undergoing heel lance procedures in a neonatal intensive care unit. Acta Paediatr. 2017 Oct;106(10):1564-1568. doi: 10.1111/apa.13944. Epub 2017 Jul 5.
- Background: PubMed 35982244Chhikara A, Hagadorn JI, Lainwala S. Effect of maternal voice on proportion of oral feeding in preterm infants. J Perinatol. 2023 Jan;43(1):68-73. doi: 10.1038/s41372-022-01493-4. Epub 2022 Aug 18.
- Background: PubMed 36191331Alabbasi Y, Parker L, Weaver M, Krueger C. Maternal Voice Exposure and Its Effect on Premature Infants' Feeding Milestones: A Systematic Review. Adv Neonatal Care. 2023 Apr 1;23(2):E40-E49. doi: 10.1097/ANC.0000000000001029. Epub 2022 Oct 3.
- 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.
Semra Küçük, Research Assistant,Phd Student principal investigator
Acibadem 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 Maternal voice in people with Preterm and Oral Feeding Performance, run by Acibadem University at 1 site in Turkey (Türkiye).
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 8 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: finished, as of the sponsor's last update on 6 Jul 2026. 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 Turkey (Türkiye). 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?
Change in Oral Feeding Performance (time frame: The first day the infant transitions to full oral feeding and the 5th day will be evaluated. The change between these time points will be assessed.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07068581, which also lists 5 linked publications.
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 6 Jul 2026.