Mother's voice during feedings to help preterm babies feed better
Effect of Maternal Voice on Physiological Indicators and Feeding Performance During Full Oral Feeding Transition in Preterm Infants: A Randomized Controlled Trial
This test plays a mother's voice during feedings to see if it helps preterm infants keep steadier oxygen levels, lower heart and breathing rates, and improve feeding performance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 1 Day to 28 Days |
| Sex | All |
| Sponsor | Acibadem University Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07068581 on ClinicalTrials.gov |
What this trial studies
Preterm infants who are beginning the transition to full oral feeding are assigned to hear their mother's voice during the entire feeding or to receive standard feeding care, with physiological signs and feeding outcomes recorded. Primary measures include oxygen saturation, heart rate, respiratory rate, feeding maturation, and percentage of nutrient intake during feeds. Eligible infants are born at 28–34 weeks gestation, are at least 30 postmenstrual weeks and ≥1000 g, have passed a hearing screen, and whose mothers can provide expressed breast milk and speak Turkish. The intervention is delivered in the NICU at Acibadem University in Istanbul and compares continuous maternal vocal stimulation during feedings versus usual care.
Who should consider this trial
Good fit: Ideal candidates are preterm infants born at 28–34 weeks gestation who are ≥30 postmenstrual weeks old, weigh at least 1000 g, have passed hearing screening, and whose Turkish-speaking mothers can provide expressed breast milk and consent to play their voice during feedings.
Not a fit: Infants with major brain injury, congenital anomalies, severe intraventricular hemorrhage or necrotizing enterocolitis, those with hearing risk or whose mothers cannot participate, or infants outside the gestational/weight limits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could help infants stabilize physiologically and reach full oral feeding sooner, potentially shortening hospital stays and supporting development.
How similar studies have performed: Small prior studies have reported positive effects of maternal voice on physiological stability and feeding in preterm infants, but the overall high-quality evidence is limited and results have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Istanbul
- Acibadem University — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Semra Küçük, Research Assistant,Phd Student — Acibadem University
- Study coordinator: Semra Küçük, Research Assistant,Phd Student
- Email: semra.kucuk@acibadem.edu.tr
- Phone: 0216- 544- 3666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.