NCT05543005

Efficacy Study of an Audio Device Outside Incubator Allowing Broadcasting Maternal Voice on Stability in Preterm Infants

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Chia-Jung Lin · Academic / Other
• Sex: All
• Age: 28 Weeks – 36 Weeks
• Healthy volunteers: Accepted

Summary

The study aims to evaluate the impact on the preterm infants' short-term physiological, neurodevelopmental states by employing maternal voice intervention in NICU routine care. This study also evaluates the correlation between effective intervention and maternal depression by employing Edinburgh Postnatal Depression Scale .

Detailed description

The study designs a two-arm, double blind randomized control trial (RCT) experiment in terms of a block randomization for allocating participants in experimental and control groups respectively. In the experimental group maternal voice in terms of lullaby, music, and meaningful words plays near the head of premature infant in the incubator by 30 mins each time, and totally three times a day over a 14-days intervention duration. Meanwhile a standard care treats premature infants in the control group. A IntelliVue physiological monitor and a behavior scale collects ECG, respiratory rate, SpO2 concentration, and sleep/awake states of premature infants in both groups. Finally, ANOVA analyzes the statistical significance between the measurer and items.

Conditions

• Premature Infant

Interventions

Type	Name	Description
OTHER	maternal voice intervention	maternal voice in terms of lullaby, music, and meaningful words plays near the head of premature infant in the incubator by 30 mins each time after routine care period

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-12-31
• Completion: 2024-07-31
• First posted: 2022-09-16
• Last updated: 2022-09-16