Effect of Maternal Voice on Physiological Indicators and Feeding Performance

NCT07068581 | Recruiting

• 1 other identifier: ATADEK-2025/09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Preterm; Oral Feeding Performance

Keywords

Preterm infants; Oral feeding performance; Maternal voice; NICU care

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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.

Study Arms (2)

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.

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.

Other: Control Group (standard feeding )

Interventions

Maternal voice PROCEDURE

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.

Maternal voice group

Control Group (standard feeding ) OTHER

The control group will not be exposed to maternal voice, and standard feeding procedures will be applied.

Standard feeding group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem University

Istanbul, 34260, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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.

  PMID: 25892736 BACKGROUND

• Chorna 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.

  PMID: 24534413 BACKGROUND

• Chirico 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.

  PMID: 28580602 BACKGROUND

• Chhikara 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.

  PMID: 35982244 BACKGROUND

• Alabbasi 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.

  PMID: 36191331 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Semra Küçük, Research Assistant,Phd Student

  Acibadem University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Semra Küçük, Research Assistant,Phd Student

CONTACT

0216- 544- 3666; semra.kucuk@acibadem.edu.tr

Duygu Gözen, Professor Doctor

CONTACT

0212-311-2640; dugozen@ku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: August 10, 2025
• Primary Completion (Estimated): July 23, 2026
• Study Completion (Estimated): July 23, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)