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

Premature Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05543005
• Other study ID #: 111119-F
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: September 2022
• Source: Far Eastern Memorial Hospital
• Contact: Chia Jung LIN, master
• Phone: +886-928185501
• Email: chiajung12[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Weeks to 36 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Infant

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chia-Jung Lin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart rate	observation at 7th and 14th day after intervention period	14th day
Primary	respiratory rate	observation at 7th and 14th day after intervention period	14th day
Primary	SpO2 concentration	observation at 7th and 14th day after intervention period	14th day
Primary	behavioral status with crying states of premature infants	observation at 7th and 14th day after intervention period	14th day