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

Primary Purpose

Premature Infant

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
maternal voice intervention
Sponsored by
Chia-Jung Lin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Premature Infant focused on measuring premature infant

Eligibility Criteria

28 Weeks - 36 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    experimental group

    control group

    Arm Description

    maternal voice

    no maternal voice

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 30, 2022
    Last Updated
    September 13, 2022
    Sponsor
    Chia-Jung Lin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05543005
    Brief Title
    Efficacy Study of an Audio Device Outside Incubator Allowing Broadcasting Maternal Voice on Stability in Preterm Infants
    Official Title
    Efficacy Study of an Audio Device Outside Incubator Allowing Broadcasting Maternal Voice on Stability in Preterm Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    July 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Chia-Jung Lin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Infant
    Keywords
    premature infant

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model 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.
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    maternal voice
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    no maternal voice
    Intervention Type
    Other
    Intervention Name(s)
    maternal voice intervention
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    heart rate
    Description
    observation at 7th and 14th day after intervention period
    Time Frame
    14th day
    Title
    respiratory rate
    Description
    observation at 7th and 14th day after intervention period
    Time Frame
    14th day
    Title
    SpO2 concentration
    Description
    observation at 7th and 14th day after intervention period
    Time Frame
    14th day
    Title
    behavioral status with crying states of premature infants
    Description
    observation at 7th and 14th day after intervention period
    Time Frame
    14th day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    28 Weeks
    Maximum Age & Unit of Time
    36 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Preterm infants at 28-36 gestational age Within 10 days in NICU after delivery Exclusion Criteria: Has a known chromosomal or congenital abnormality Major congenital infection Brain lesions diagnosed prenatally, or neonatal asphyxia at birth. Toxic use by the mother during pregnancy Intraventricular hemorrhage of third degree or more occurred in brain ultrasound examination Are using sedative medication Premature infants use endotracheal tube respirator or high-frequency respirator Preterm infants requiring immediate surgical treatment at birth
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chia Jung LIN, master
    Phone
    +886-928185501
    Email
    chiajung12@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

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

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