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

September 13, 2022 updated by: Chia-Jung Lin
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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
maternal voice
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
No Intervention: control group
no maternal voice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate
Time Frame: 14th day
observation at 7th and 14th day after intervention period
14th day
respiratory rate
Time Frame: 14th day
observation at 7th and 14th day after intervention period
14th day
SpO2 concentration
Time Frame: 14th day
observation at 7th and 14th day after intervention period
14th day
behavioral status with crying states of premature infants
Time Frame: 14th day
observation at 7th and 14th day after intervention period
14th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia-Jung Lin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

August 30, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111119-F

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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