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

Not Applicable

Not yet recruiting

• Conditions: Premature Infant
• Interventions: Other: maternal voice intervention

• Registration Number: NCT05543005
• Lead Sponsor: Chia-Jung Lin

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.

Study Timeline

• Study First Submitted: 2022-08-30
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-13
• Last Update Submitted: 2022-09-13
• Study First Posted: 2022-09-16
• Last Update Posted: 2022-09-16
• Study Start: 2022-10-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	maternal voice intervention	maternal voice

Primary Outcome Measures

Name	Time	Method
heart rate	14th day	observation at 7th and 14th day after intervention period
respiratory rate	14th day	observation at 7th and 14th day after intervention period
SpO2 concentration	14th day	observation at 7th and 14th day after intervention period
behavioral status with crying states of premature infants	14th day	observation at 7th and 14th day after intervention period