Actively Recruiting

Phase Not Applicable
Age: 1Day - 28Days
All Genders
Healthy Volunteers
ID07068581

Effect of Maternal Voice on Physiological Indicators and Feeding Performance During Full Oral Feeding Transition in Preterm Infants: A Randomized Controlled Trial

Led by Acibadem University · Updated on 2025-12-18

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are exploring how a mother's voice affects the health and feeding skills of preterm infants. This study focuses on whether listening to a lullaby recorded in the mother's voice during feeding can improve oxygen levels, heart rates, breathing rates, and feeding performance. The goal is to understand if maternal voice helps preterm infants feed better and grow more effectively, filling gaps where past studies have shown mixed results. In this trial, preterm infants in the experimental group will hear their mother's recorded lullaby twice daily, starting 20 minutes before morning and evening feedings and continuing throughout the feeding session, for up to five days. Each infant will have a personal Bluetooth-enabled speaker placed near them for playback. The control group will receive standard feeding care without any voice playback. Both groups will have their physiological signs and feeding progress measured. Participants will undergo daily monitoring of oxygen saturation, heart rate, respiratory rate, and oral feeding skills for five days, including assessments before, during, and after feeding. Researchers will compare changes in these measures from the first day of full oral feeding to the fifth day. The study period lasts up to five days or until early discharge. The study aims to provide evidence on how maternal vocal stimulation can support feeding development in preterm infants.

CONDITIONS

Brief Title

Effect of Maternal Voice on Physiological Indicators and Feeding Performance

Who Can Participate

Age: 1Day - 28Days
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm infants born at gestational age 6528 weeks and 6534 weeks
  • Infants who are 6530 postmenstrual weeks old at the time of enrollment
  • Infants weighing 6531000 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 5 days or until discharge

Participants transition to full oral feeding. In the experimental group, maternal voice recordings will be played twice daily before and during feeding sessions for up to 5 days. The control group will receive standard feeding care without maternal voice intervention.

Twice daily feeding sessions for up to 5 days

Monitoring

Duration - 5 days

Physiological indicators such as oxygen saturation, heart rate, and respiratory rate, along with oral feeding performance, are measured daily during the treatment period to assess changes related to feeding.

Daily measurements before, during, and after feeding

Trial Site Locations

Total: 1 location

1

Acibadem University

Istanbul, Turkey (Türkiye), 34260

Actively Recruiting

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Research Team

S

Semra Küçük, Research Assistant,Phd Student

D

Duygu Gözen, Professor Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Randomised study showed that recorded maternal voices reduced pain in preterm infants undergoing heel lance procedures in a neonatal intensive care unit.

G Chirico, R Cabano, G Villa...

https://pubmed.ncbi.nlm.nih.gov/28580602