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Effect of daily 10 minute maternal voice on physiological and behavioral measures in premature infants in Neonatal Intensive Care Unit (NICU) : A Randomized Controlled Trial

Effect of maternal voice on physiological and behavioral measures in premature infants : A Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000722594
Enrollment
140
Registered
2015-07-13
Start date
2015-06-01
Completion date
2015-11-10
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Premature infants usually will need to stay in NICU and underwent multiple treatment and procedure till they reach certain age and weight before being discharge home. This will lead to separations from mother and multiple interventions leads to stress related behaviour. Previous research had proved that some intervention as kangaroo care, swaddling and non nutritive sucking can be used for premature infants to significantly manage pain and stress related behaviors.Studies also have shown that preterm infants who were exposed to an audio recording of their mother’s voice achieved full oral feed quicker and showed meaningful changes in heart rate compared to preterm infants receiving routine care. This study objective is to look at effect of mothers voice on premature infants heart rate, breathing, stress related behaviour and weight gain. The study involve exposing premature infant to recorded maternal voice for 10 min everyday for 2 weeks duration. It is interesting to see if this maternal voice recording can be used to temporarily replaced mother’s who are not able to room in or visit their premature infants in NICU due to various reason.

Interventions

Premature baby with corrected gestational age (CGA) between 27 to 35 weeks period of gestation (POG). CGA is calculated as POG plus current age of baby in weeks. Subject will be exposed to recording of their mothers voice for 10 minutes every day for 2 weeks. Their mother will be given a recorder prior to the study, she will be asked to record her voice in any form i.e. singing, talking,rhyming, reading for 10minutes. The same recording will be played to their babies daily for 2 weeks. T

Premature baby with corrected gestational age (CGA) between 27 to 35 weeks period of gestation (POG). CGA is calculated as POG plus current age of baby in weeks. Subject will be exposed to recording of their mothers voice for 10 minutes every day for 2 weeks. Their mother will be given a recorder prior to the study, she will be asked to record her voice in any form i.e. singing, talking,rhyming, reading for 10minutes. The same recording will be played to their babies daily for 2 weeks. The recording will be played during daytime, after feeding was given. The volume of the sound will be kept at 50-55dB as recommended by American Academy of Paediatrics. Their biophysical parameter (Heart Rate, Respiratory Rate, SPO2) and neurobehavioral score will be monitored pre, during and post intervention daily.

Sponsors

HOSPITAL SULTANAH BAHIYAH
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
1 Days to 8 Weeks
Healthy volunteers
No

Inclusion criteria

1. All premature infants with corrected gestational age (CGA) 27-35 weeks 2. Achieved full feeding of at least 120cc/kg/day 3. Infant must be nursed in closed incubator (isolette)

Exclusion criteria

1.Premature baby who are on mechanical ventilation 2.Medically unstable infant: HIE, NEC, sepsis, on inotropic support 3.Infant with major congenital anomalies 4.Infant who is still on intravenous drip or parenteral nutrition Dropout criteria 1.Infant who need to be ventilated during study period 2.Infant who need to be kept nil by mouth during study period 3.Infant who become medically unstable determined by treating clinician: HIE, NEC, sepsis, on inotropes etc

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026