Clinical trial NCT05543005: Efficacy Study of an Audio Device Outside Incubator Allowing Broadcasting Maternal Voice on Stability in Preterm Infants
Official title: Efficacy Study of an Audio Device Outside Incubator Allowing Broadcasting Maternal Voice on Stability in Preterm Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Infant
Keywords: premature infant
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 80
Sex: ALL
Minimum age (years): 28
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Preterm infants at 28-36 gestational age
* Within 10 days in NICU after delivery

Exclusion Criteria:

1. Has a known chromosomal or congenital abnormality
2. Major congenital infection
3. Brain lesions diagnosed prenatally, or neonatal asphyxia at birth.
4. Toxic use by the mother during pregnancy
5. Intraventricular hemorrhage of third degree or more occurred in brain ultrasound examination
6. Are using sedative medication
7. Premature infants use endotracheal tube respirator or high-frequency respirator
8. Preterm infants requiring immediate surgical treatment at birth

Primary outcomes:
measure: heart rate
timeFrame: 14th day
measure: respiratory rate
timeFrame: 14th day
measure: SpO2 concentration
timeFrame: 14th day
measure: behavioral status with crying states of premature infants
timeFrame: 14th day
Secondary outcomes:
Other outcomes:
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Study officials:
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