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SENSE trial: Language Exposure of Preterm Infants in the Neonatal Unit

Sensory Exposure of Neonates in the Single-room Environment (SENSE): A multi-method trial of sound and language exposure in preterm neonates cared for in single-room environments on developmental outcomes up to 2 years.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000272291
Acronym
SENSE
Enrollment
50
Registered
2018-02-22
Start date
2018-08-03
Completion date
2020-01-02
Last updated
2020-12-07

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

Conditions

None listed

Brief summary

The objective of the study is to determine if a predefined quotient of supplementary language exposure improves short, intermediate and long-term neurodevelopmental outcomes in preterm infants (<30 weeks) cared for in the neonatal unit. Participants <30 weeks gestational age, admitted to the Neonatal Intensive Care Unit, will be randomised to receive either one of two levels of supplemental language exposure in the form of recorded maternal voice, delivered via micro speaker. The intervention group will receive a treatment level of exposure of 6000 words/hour and the control group will receive a placebo of 600 words/hour within a developmental appropriate decibel range. The exposure will occur for one hour, three times daily, commencing on day 7 of life until 37 weeks gestational age or discharge. The level of 6000 words was chosen as the rate of slow speech is approximately 100 words/minute. Mothers of participants included in the trial will be directed to speak in 'motherese' style language at this rate for ten minutes. The recording will then be repeated six times. Control group infants will receive 10% of the language exposure level of the intervention group.

Interventions

Participants will be randomised to receive either one of two levels of supplemental language exposure in the form of recorded maternal voice, delivered by microspeaker. The intervention will take place in the single-room designed Neonatal Intensive Care Unit and Special Care Nursery of the Gold Coast University Hospital. The intervention group will receive a treatment level of exposure of 6000 words/hour and the control group will receive a low-dose of 600 words/hour within a developmental appr

Participants will be randomised to receive either one of two levels of supplemental language exposure in the form of recorded maternal voice, delivered by microspeaker. The intervention will take place in the single-room designed Neonatal Intensive Care Unit and Special Care Nursery of the Gold Coast University Hospital. The intervention group will receive a treatment level of exposure of 6000 words/hour and the control group will receive a low-dose of 600 words/hour within a developmental appropriate decibel range. Each group will receive the exposure over one hour, three times daily. The mother of each enrolled participant will be asked to read a short story selected by the research team, for ten minutes. This recording will be processed using a software program to convert the 10 minute reading into an mp3 recording which will automatically play the desired 'dose' throughout the day at three 1-hour intervals. A team of research nurses enrolled in the study will be responsible for pressing play on the recording in the morning.

Sponsors

The University of Queensland
Lead SponsorUniversity

Study design

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

Eligibility

Sex/Gender
All
Age
No minimum to 7 Days
Healthy volunteers
No

Inclusion criteria

All preterm infants born at <30 weeks gestation or <1000g who are admitted to the NICU at Gold Coast University Hospital, with at least one consenting parent and mother who is willing to provide a recording of maternal voice in infant-directed speech.

Exclusion criteria

Significant neurological conditions (e.g., severe IVH). Preterm infants so critically unwell that they are not expected to survive.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026