NCT03564184: LongSTEP

Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers

Completed NA Last updated 22 November 2022

What this trial tests

NA trial testing MT during NICU in Preterm Birth in 213 participants. Completed in 31 August 2022.

Timeline

25 August 2018

Primary endpoint
31 December 2020

31 August 2022

Quick facts

Lead sponsor	NORCE Norwegian Research Centre AS
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	213
Start date	25 August 2018
Primary completion	31 December 2020
Estimated completion	31 August 2022
Sites	10 locations across Colombia, Israel, Poland, Norway, Argentina

Drugs / interventions tested

• MT during NICU
• MT after NICU
• Standard care — full drug profile →

Conditions studied

• Preterm Birth — all drugs for Preterm Birth →

Sponsor

NORCE Norwegian Research Centre AS

Who can join

Eligibility, any sex, with Preterm Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Preterm birth has major medical, psychological and socio-economic consequences worldwide. A recent systematic review suggests positive effects of music therapy (MT) on physiological measures of preterm infants and maternal anxiety, but methodologically rigorous studies including long-term follow-up of infant and parental outcomes are missing. Drawing upon caregivers' inherent resources, this study emphasizes caregiver involvement in MT to promote attuned, developmentally-appropriate musical interactions that may be of mutual benefit to infant and parent. This study will determine whether MT, as delivered by a qualified music therapist during neonatal intensive care unit (NICU) hospitalization and/or in home/municipal settings following discharge, is superior to standard care in improving bonding between primary caregivers and preterm infants, parent well-being and infant development.

Methods: Design: International multi-center, assessor-blind, 2x2 factorial, pragmatic randomized controlled trial. A feasibility study has been completed; ethical approval for the main trial is pending. Participants: 250 preterm infants and their parents. Intervention: MT focusing on singing specifically tailored to infant responses, will be delivered during NICU and/or during a post-discharge 6-month period. Primary outcome: Changes in mother-infant bonding until 6 months corrected age (CA), as measured by the Postpartum Bonding Questionnaire. Secondary outcomes: Mother-infant bonding at discharge and over 12 months CA; child development over 24 months; and parental depression, anxiety, and stress, and infant re-hospitalization, all over 12 months.

Discussion: This study fills a gap by measuring the long-term impact of MT for preterm infants/caregivers, and of MT beyond the hospital context. Outcomes related to highly involving parents in MT will directly inform the development of clinical practice in Scandinavia and other contexts with similar social welfare practices. By incorporating family-centered care, continuity of care, user involvement, and cultural relevance, this study can potentially contribute to improved quality of care for premature infants and their parents worldwide.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Longitudinal Study of music Therapy's Effectiveness for Premature infants and their caregivers (LongSTEP): protocol for an international randomised trial.
   Ghetti C, Bieleninik Ł, Hysing M, Kvestad I, et al · · 2019 · cited 28× · PMID 31481362 · DOI 10.1136/bmjopen-2018-025062
2. Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers (LongSTEP): Feasibility Study With a Norwegian Cohort.
   Ghetti CM, Vederhus BJ, Gaden TS, Brenner AK, et al · · 2021 · cited 20× · PMID 33448286 · DOI 10.1093/jmt/thaa023
3. Effect of Music Therapy on Parent-Infant Bonding Among Infants Born Preterm: A Randomized Clinical Trial.
   Ghetti CM, Gaden TS, Bieleninik L, Kvestad I, et al · · 2023 · cited 10× · PMID 37234006 · DOI 10.1001/jamanetworkopen.2023.15750
4. Music Therapy in Infancy and Neurodevelopmental Outcomes in Preterm Children: A Secondary Analysis of the LongSTEP Randomized Clinical Trial.
   Bieleninik L, Kvestad I, Gold C, Stordal AS, et al · · 2024 · cited 5× · PMID 38753331 · DOI 10.1001/jamanetworkopen.2024.10721
5. Treatment fidelity in a pragmatic clinical trial of music therapy for premature infants and their parents: the LongSTEP study.
   Gaden TS, Gold C, Assmus J, Kvestad I, et al · · 2023 · cited 5× · PMID 36869392 · DOI 10.1186/s13063-022-06971-w
6. The effect of paternal anxiety on mother-infant bonding in neonatal intensive care.
   Ettenberger M, Bieleninik Ł, Stordal AS, Ghetti C. · · 2024 · cited 4× · PMID 38212696 · DOI 10.1186/s12884-023-06179-z