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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Premature Infant

Intervention / Treatment
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* Other: maternal voice intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants at 28-36 gestational age Within 10 days in NICU after delivery Exclusion Criteria: Has a known chromosomal or congenital abnormality Major congenital infection Brain lesions diagnosed prenatally, or neonatal asphyxia at birth. Toxic use by the mother during pregnancy Intraventricular hemorrhage of third degree or more occurred in brain ultrasound examination Are using sedative medication Premature infants use endotracheal tube respirator or high-frequency respirator Preterm infants requiring immediate surgical treatment at birth

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 36 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>maternal voice | Other: maternal voice intervention<br>* 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<br>|
| No Intervention: control group<br>no maternal voice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate | observation at 7th and 14th day after intervention period | 14th day | 
| respiratory rate | observation at 7th and 14th day after intervention period | 14th day | 
| SpO2 concentration | observation at 7th and 14th day after intervention period | 14th day | 
| behavioral status with crying states of premature infants | observation at 7th and 14th day after intervention period | 14th day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature infant