ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626000846325p

Ethics application status

Submitted, not yet approved

Date submitted

11/06/2026

Date registered

13/07/2026

Date last updated

13/07/2026

Date data sharing statement initially provided

13/07/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Supportive Outcomes Of Therapeutic Heartbeat exposure-Neonates: (SOOTHE-Neo). A randomised Controlled Trial

Scientific title

Supportive Outcomes Of Therapeutic Heartbeat exposure-Neonates: (SOOTHE-Neo). A randomised Controlled Trial

Additional trial identifiers [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

SOOTHE-Neo

Related trial records

Health condition

Health condition(s) studied:

Pain

neonatal surgery

Condition category

Condition code

Anaesthesiology

Pain management

Surgery

Other surgery

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

What is the intervention:
A recording of the baby's maternal heartbeat (utilising a digital recording stethoscope) placed near the infant and played on a continuous loop for 48 hours after infant returns to the neonatal unit following surgery. The sound level will be carefully checked to ensure it remains within safe limits for newborns (45-50 dB) using the calibrated sound meter and will not interfere with normal care or monitoring. This sound level will be check once per shift and noted on the bedside observation chart. All other aspects of the infants care, including analgesia will continue the same regime as is per usual post-operative analgesic management. There is no current guideline or standardisation for neonatal post-operative pain relief and clinical management of analgesia is dependent on Neonatologist/treating medical team on service. Titration and weaning of analgesia is completed following review/discussion with Medical Officer (MO)/ Neonatal Nurse Practitioner (NNP). Pain scores, using the Pain Assessment Tool( PAT) are used to help guide the decision to titrate analgesia weaning.

Intervention code [1]

Prevention

Description of the comparator or control

Following return to the neonatal intensive care unit form the operating theatre, participants randomised to the control group will continue the same regime as is per usual post-operative analgesic management. There is no current guideline or standardisation for neonatal post-operative pain relief and clinical management of analgesia is dependent on Neonatologist/treating medical team on service. Titration and weaning of analgesia is completed following review/discussion with MO/NNP. Pain scores, using the PAT tool are used to help guide the decision to titrate analgesia weaning.

Control group

Active

Outcomes

Primary outcome [1]

Incidence of pain

Timepoint [1]

48hrs post-operatively

Secondary outcome [1]

Amount of analgesia received

Timepoint [1]

48hrs post operatively

Secondary outcome [2]

Adverse physiological events evidenced by cardiorespiratory events/ vitals

Timepoint [2]

anytime within the 48hrs post-operatively

Secondary outcome [3]

Stress

Timepoint [3]

6 and 24hrs post-operative

Secondary outcome [4]

Parental experience

Timepoint [4]

48hrs - 7 days post surgery

Secondary outcome [5]

Analgesia category (mild, mod or severe range of morphine infant receiving) at 48hrs postoperatively

Timepoint [5]

at 48hrs postoperatively

Eligibility

Key inclusion criteria

Infants > 32weeks requiring surgery (eligible to use the PAT score)
Parents/guardians able provide written informed consent.

Minimum age

32 Weeks

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

Infants requiring emergency surgery within 30mins

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)

A batch of 66 opaque, sequentially numbered envelopes will be prepared by a research assistant, independent of the research team. Following identification of a potential participant, one envelope will be selected in sequential order and brought to the site of the potential participant. This will be opened at the participant’s cot-side once consent has been verified. This envelope will assign the participant to either the control or intervention group and care will be followed accordingly. The envelopes will be kept in a locked drawer within the office of the Clinical Nurse Consultant in the neonatal unit

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated random sequence

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

The PAT is a 20-point scale; however, local audit data indicate that postoperative scores in this population are generally low, typically within the range of 0–4 within the first 48hrs, with limited variability and infrequent higher scores. Using a two sample t-test assuming equal variance, the minimum required sample size was calculated as 26 participants per group (N=52), assuming a 1-point difference in mean PAT score, standard deviation of 1.25, 80% power, and a=0.05.However, given the low range and limited variability of PAT scores, potential non-normality, and the risk that the true effect size may be smaller than anticipated, this sample size calculation will be performed based on the primary outcome of mean PAT score over the first 48 hours postoperatively. estimate may be optimistic. To ensure adequate power under more conservative assumptions and to account for potential attrition, the target sample size has been increased to 33 per group (N=66), assuming a 20% attrition rate. Sample size was calculated using PASS 2020 v20.0.8.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

11/09/2026

Actual

Date of last participant enrolment

Anticipated

28/02/2027

Actual

Date of last data collection

Anticipated

7/03/2027

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Mater Mother's Hospital - South Brisbane

Recruitment postcode(s) [1]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Mater Foundation

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Mater Mothers' Hospital

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Mater Misericordiae Ltd Human Research Ethics Committee

Ethics committee address [1]

http://www.materresearch.org.au/about-us/human-research-ethics-and-governance/human-research-ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/05/2026

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

This study investigates whether playing recorded maternal heartbeat sounds to babies after surgery can improve their recovery. The researchers hypothesise that this familiar, soothing sound will reduce pain, improve physiological stability (such as heart rate, breathing, and oxygen levels), and decrease the need for pain medications. The main outcome will be differences in pain scores over the first 48 hours after surgery, while secondary outcomes include cardiorespiratory stability, analgesic use, stress hormone levels, and parent satisfaction. Overall, the study aims to test a simple, low-risk intervention that could enhance comfort and recovery for vulnerable newborns.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Renee Muirhead

Address

NCCU, Mater Mothers Hospital, Raymond Terrace, South Brisbane, QLD 4101

Country

Australia

Phone

+61 402036371

Fax

[email protected]

Contact person for public queries

Name

Renee Muirhead

Address

NCCU, Mater Mothers Hospital, Raymond Terrace, South Brisbane, QLD. 4101

Country

Australia

Phone

+61 402036371

Fax

[email protected]

Contact person for scientific queries

Name

Renee Muirhead

Address

NCCU, Mater Mothers Hospital, Raymond Terrace, South Brisbane, QLD. 4101

Country

Australia

Phone

+61 402036371

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: Privacy concerns

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Study protocol					Supportive Outcomes Of Therapeutic Heartbeat Exposure_ANZCTR.docx

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically