CClinicalTrials.gg
Status unknownNCT05543005Updated Sep 16, 2022

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

An interventional study of maternal voice intervention in Premature Infant, sponsored by Chia-Jung Lin. Status unknown. Open to participants aged 28 Weeks to 36 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-16.

Sponsored by Chia-Jung Lin · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
28 Weeks to 36 Weeks
Sex
All
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Study 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 .

Read the 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.

02

Conditions studied

  • Premature Infant

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Keywords

  • premature infant
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's planned enrollment of 80 is close to the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

This is the only study on the registry with Chia-Jung Lin as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Weeks to 36 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    experimental group

    maternal voice

    Other: maternal voice intervention

  • No intervention
    control group

    no maternal voice

Interventions

  • Othermaternal 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

06

What researchers measure

Primary outcomes

  1. heart rate

    observation at 7th and 14th day after intervention period

    Time frame: 14th day

  2. respiratory rate

    observation at 7th and 14th day after intervention period

    Time frame: 14th day

  3. SpO2 concentration

    observation at 7th and 14th day after intervention period

    Time frame: 14th day

  4. behavioral status with crying states of premature infants

    observation at 7th and 14th day after intervention period

    Time frame: 14th day

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05543005
Lead sponsor
Chia-Jung Lin
Responsible party
Chia-Jung Lin (nurse practitioner, Far Eastern Memorial Hospital) — Sponsor-investigator
First posted
Sep 16, 2022
Start date
Oct 1, 2022 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
Jul 31, 2024 (estimated)
Last update
Sep 16, 2022

Study contacts

Chia Jung LIN, master
Contact
chiajung12@gmail.com
+886-928185501

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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