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

NCT05543005 | Unknown DMC

• 1 other identifier: 111119-F
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Premature Infant

Keywords

premature infant

Outcome Measures

Primary Outcomes (4)

• heart rate

  observation at 7th and 14th day after intervention period

  14th day

• respiratory rate

  observation at 7th and 14th day after intervention period

  14th day

• SpO2 concentration

  observation at 7th and 14th day after intervention period

  14th day

• behavioral status with crying states of premature infants

  observation at 7th and 14th day after intervention period

  14th day

Study Arms (2)

experimental group

EXPERIMENTAL

maternal voice

Other: maternal voice intervention

control group

NO INTERVENTION

no maternal voice

Interventions

maternal voice intervention OTHER

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

experimental group

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chia-Jung Lin: lead

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Chia Jung LIN, master

CONTACT

+886-928185501; chiajung12@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: nurse practitioner

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 16, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: July 31, 2024
• Last Updated: September 16, 2022

Record last verified: 2022-09