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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-07-31

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 .

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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.

Conditions

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Premature Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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experimental group

maternal voice

Group Type EXPERIMENTAL

maternal voice intervention

Intervention Type OTHER

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

control group

no maternal voice

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

28 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes