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Effects of recorded maternal voice on heart rate and anthropometric parameters in premature infants: A randomized controlled trial

Effects of recorded maternal voice on heart rate and anthropometric parameters in premature infants: A randomized controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000019707
Enrollment
109
Registered
2022-01-11
Start date
2021-09-01
Completion date
2022-03-02
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is aimed to explore the effectiveness of recorded maternal voice on heart rate and anthropometric parameters in premature infants. The anthropometric parameters will include weight, height and head circumference. This study hypothesis that recorded maternal voice has the potential to improve participants' anthropometric parameters (i.e., weight, height, and head circumference). Additionally, participants' heat rate might have different change trends in the recorded maternal voice group.

Interventions

A specialized NICU nurse will trained for carrying out the study protocol and help mothers recording their voice. The mothers' voice will be recorded in agreement with the American Academy of Pediatrics guidelines. Mothers will be instructed by the research and nurse to record the words in a quiet environment in the same manner they had spoken to the fetus during pregnancy. They will be informed that there is no restriction of the recording content (e.g., story, nursery rhymes) and length. Then

A specialized NICU nurse will trained for carrying out the study protocol and help mothers recording their voice. The mothers' voice will be recorded in agreement with the American Academy of Pediatrics guidelines. Mothers will be instructed by the research and nurse to record the words in a quiet environment in the same manner they had spoken to the fetus during pregnancy. They will be informed that there is no restriction of the recording content (e.g., story, nursery rhymes) and length. Then, they will be asked to talk into a recorder. so every neonate heard its maternal voice with her special words, feelings and speech. The maternal voice will broadcast two times a day, with each time lasting 30 minutes (between 7 and 8 am, and 16 and 17 pm) for premature infants while they were alert and awake and had received nursing care before intervention. The recorded voice will be played on repeat from 48 hours of birth until infants are discharged from the hospital. To ensure the authenticity of the function of the devices during the intervention, the infant’s nurse will present at the bedside. In order to omit additional sounds around the participants, the intervention will be performed in one of the isolated rooms of the NICU where the noise and traffic are the least. To ensure the infants' auditory safety, the intensity of maternal voice will be monitored individually for each infant to be between 35 and 85db. The recorded voice will be broadcast placed approximately 20-30cm from the infants' heads.

Sponsors

Ping Li
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
24 Hours to 48 Hours
Healthy volunteers
No

Inclusion criteria

The participants will be premature infants at the NICU. Details of the inclusion criteria are as follows: 1. born after 28th or before 34th week of gestation 2. medically stable during the first 24 hour after birth (e.g., heart rate, blood pressure, age-appropriate rate, body temperature) 3. had no congenital malformation that could have caused asphyxia

Exclusion criteria

Infants with a history of maternal diseases (such as diabetes, preeclampsia, hypertension), drug abuse or alcoholism will be excluded from the study. Other exclusion criteria are neonates who have congenital anomalies; congenital hearing loss; viral, fungal or bacterial infections; metabolic disorders or diseases, intraventricular hemorrhage or other cranial pathologies; acute diseases such as asphyxia and necrotizing enterocolitis; a history of receiving mechanical ventilation, respiratory support, and oxygen intake using medicines such as cardiogenic medications and muscle relaxants. Infants whose parents are not willing to participate in the study will also not be included.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026