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Trial registered on ANZCTR


Registration number
ACTRN12622000019707
Ethics application status
Approved
Date submitted
13/12/2021
Date registered
11/01/2022
Date last updated
2/05/2022
Date data sharing statement initially provided
11/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of recorded maternal voice on heart rate and anthropometric parameters in premature infants: A randomized controlled trial
Scientific title
Effects of recorded maternal voice on heart rate and anthropometric parameters in premature infants: A randomized controlled trial
Secondary ID [1] 306028 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart rate 324661 0
anthropometric parameters 324662 0
Condition category
Condition code
Reproductive Health and Childbirth 322112 322112 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A specialized NICU nurse will trained for carrying out the study protocol and help mothers recording their voice. The mothers' voice will be recorded in agreement with the American Academy of Pediatrics guidelines. Mothers will be instructed by the research and nurse to record the words in a quiet environment in the same manner they had spoken to the fetus during pregnancy. They will be informed that there is no restriction of the recording content (e.g., story, nursery rhymes) and length. Then, they will be asked to talk into a recorder. so every neonate heard its maternal voice with her special words, feelings and speech.
The maternal voice will broadcast two times a day, with each time lasting 30 minutes (between 7 and 8 am, and 16 and 17 pm) for premature infants while they were alert and awake and had received nursing care before intervention. The recorded voice will be played on repeat from 48 hours of birth until infants are discharged from the hospital. To ensure the authenticity of the function of the devices during the intervention, the infant’s nurse will present at the bedside. In order to omit additional sounds around the participants, the intervention will be performed in one of the isolated rooms of the NICU where the noise and traffic are the least. To ensure the infants' auditory safety, the intensity of maternal voice will be monitored individually for each infant to be between 35 and 85db. The recorded voice will be broadcast placed approximately 20-30cm from the infants' heads.
Intervention code [1] 322429 0
Treatment: Other
Comparator / control treatment
The control group, as well as the intervention group, will continue to receive routine nursing care. However, the control group does not receive any intervention from the project in addition to this.
Control group
Active

Outcomes
Primary outcome [1] 329883 0
weight and recumbent length using a digital baby scale with a protable length board (seca-376 digital baby scale) head circumference using a soft tape
Timepoint [1] 329883 0
The primary outcomes focused on preterm infants’ weight, recumbent length, and head circumference, collected daily during the 21-day intervention period. Infants’ weight and recumbent length were recorded using a digital baby scale with a probable length board (Seca-376 digital baby scale). Additionally, the participants’ head circumference was recorded using a soft tape by the researcher and trained nurse. All the anthropometric parameters were assessed three times using standard approaches and calculated each day’s average scores.
Secondary outcome [1] 404168 0
heart rate
Timepoint [1] 404168 0
The secondary outcome focused on preterm infants’ heart rates. Participants’ morning heart rate was recorded using the ECG monitoring device (IntelliVue MP5, PHILIPS) in the intervention and control groups once a day. All recordings were also conducted three times, and the average scores were used in the data analysis. Additionally, the heart rates of the preterm infants in the intervention group were recorded once a day during the pre-during-post intervention (i.e., 1 minute before the intervention, during the intervention, and 10 minutes after the intervention) in the morning intervention to assess the change trends of heart rate pre-during-post the recorded maternal voice intervention.

Eligibility
Key inclusion criteria
The participants will be premature infants at the NICU. Details of the inclusion criteria are as follows:
1. born after 28th or before 34th week of gestation
2. medically stable during the first 24 hour after birth (e.g., heart rate, blood pressure, age-appropriate rate, body temperature)
3. had no congenital malformation that could have caused asphyxia
Minimum age
24 Hours
Maximum age
48 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants with a history of maternal diseases (such as diabetes, preeclampsia, hypertension), drug abuse or alcoholism will be excluded from the study. Other exclusion criteria are neonates who have congenital anomalies; congenital hearing loss; viral, fungal or bacterial infections; metabolic disorders or diseases, intraventricular hemorrhage or other cranial pathologies; acute diseases such as asphyxia and necrotizing enterocolitis; a history of receiving mechanical ventilation, respiratory support, and oxygen intake using medicines such as cardiogenic medications and muscle relaxants. Infants whose parents are not willing to participate in the study will also not be included.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer-generated random numbers (i.e., 1-109, odd numbers as the intervention group, and even numbers as the control group)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2021
Date of last participant enrolment
Anticipated
15/03/2022
Actual
2/03/2022
Date of last data collection
Anticipated
15/04/2022
Actual
22/03/2022
Sample size
Target
108
Accrual to date
Final
109
Recruitment outside Australia
Country [1] 24397 0
China
State/province [1] 24397 0
Shandong province

Funding & Sponsors
Funding source category [1] 310368 0
Self funded/Unfunded
Name [1] 310368 0
Ping Li
Country [1] 310368 0
China
Primary sponsor type
Individual
Name
Ping Li
Address
Shandong University, 44 Wenhua Road, Jinan, Shandong, China, 250012
Country
China
Secondary sponsor category [1] 311503 0
Individual
Name [1] 311503 0
Meiling Qi
Address [1] 311503 0
Shandong University, 44 Wenhua Road, Jinan, Shandong, China, 250012
Country [1] 311503 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310021 0
Ethics Committee of Nursing and Rehabilitation College of Shandong University
Ethics committee address [1] 310021 0
Ethics committee country [1] 310021 0
China
Date submitted for ethics approval [1] 310021 0
Approval date [1] 310021 0
05/06/2021
Ethics approval number [1] 310021 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116210 0
Prof Ping Li
Address 116210 0
Shandong University, 44 Wenhua Road, Jinan, Shandong, China, 250012
Country 116210 0
China
Phone 116210 0
+86 0531 88386628
Fax 116210 0
Email 116210 0
[email protected]
Contact person for public queries
Name 116211 0
Ping Li
Address 116211 0
Shandong University, 44 Wenhua Road, Jinan, Shandong, China, 250012
Country 116211 0
China
Phone 116211 0
+86 0531 88386628
Fax 116211 0
Email 116211 0
[email protected]
Contact person for scientific queries
Name 116212 0
Ping Li
Address 116212 0
Shandong University, 44 Wenhua Road, Jinan, Shandong, China, 250012
Country 116212 0
China
Phone 116212 0
+86 0531 88386628
Fax 116212 0
Email 116212 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data underlying published results only
When will data be available (start and end dates)?
The data will be available immediately following publication, and available for 5 years after publication.
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator (Prof Ping Li email at [email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14412Ethical approval    383288-(Uploaded-13-12-2021-16-00-07)-Study-related document.pdf



Results publications and other study-related documents

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