Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers
LongSTEP
1 other identifier
interventional
213
5 countries
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2018
CompletedFirst Posted
Study publicly available on registry
June 20, 2018
CompletedStudy Start
First participant enrolled
August 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedNovember 22, 2022
November 1, 2022
2.4 years
June 10, 2018
November 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bonding between primary caregiver and infant
Total score of the Postpartum Bonding Questionnaire (PBQ), a parent-rated screening instrument for disorders of the early mother-infant relationship consisting of 25 statements on a six-point Likert scale (each 0-5; sum score ranging from 0 to 125; high = problematic).
6 months
Secondary Outcomes (8)
Bonding between primary caregiver and infant
12 months
Child development
24 months
Infant development
12 months
Infant socio-emotional development
12 months
Re-hospitalization
12 months
- +3 more secondary outcomes
Study Arms (4)
MT during and after NICU
EXPERIMENTALConsists of music therapy during NICU hospitalization, and music therapy after discharge from initial NICU hospitalization, along with standard care.
MT during NICU
EXPERIMENTALConsists of music therapy during NICU hospitalization, along with standard care.
MT after NICU
EXPERIMENTALConsists of music therapy after discharge from initial NICU hospitalization, along with standard care.
No MT
EXPERIMENTALConsists of standard care.
Interventions
Music therapy (MT) by trained music therapist, 3 times/week for 30-40 minutes/session during NICU hospitalization. Involves primary caregiver and infant in musical communication matched to infant post-menstrual age, family/cultural preferences, and infant readiness for stimulation. Music therapist assesses infant´s needs and behavior state, supports caregiver in using basic touch (e.g., hand lightly and statically on infant´s chest or back to perceive breathing pattern) and caregiver´s hummed/sung voice matched to infant behavioral responses, to promote infant state regulation and bonding. Music includes input from music therapist as needed, and multimodal aspects such as gentle dynamic touch when infant demonstrates readiness. MT may occur while infant is held in a static manner by caregiver or is resting in his/her isolette or basinet. MT may occur during skin-to-skin care, if such care is part of standard care.
Music therapy offered by trained music therapist, 7 times for approximately 45 minutes/session across first 6 months following discharge from initial NICU hospitalization. Sessions include infant and caregiver, and siblings, if desired, and occur at home or in municipal settings. MT after NICU consists of a consult-to-parent model with each session including a brief verbal check-in regarding infant´s progress, musical interactions with music therapist modelling musical engagement, discussion of current challenges and strategies for using musical interactions to address needs in areas such as infant self-regulation, parent/infant interaction, and challenges with bonding. Caregivers will demonstrate techniques discussed during session, and form a brief plan for use of musical interaction in the interim before next session. Sessions will be adapted to infant developmental level and ongoing needs.
Includes necessary medical care and standard supportive interventions offered as part of care during hospitalization, and standard follow-up procedures post-hospitalization.
Eligibility Criteria
You may qualify if:
- born below 35 weeks gestational age
- determined by medical staff to have achieved sufficient medical stability to start MT
- likely to be hospitalized longer than 2 weeks from time of recruitment
- willing to engage in at least 2 of 3 MT sessions per week during NICU and/or in 5 of 7 MT post-discharge sessions, if randomized to receive MT
- live with reasonable commuting distance from the treating NICU
- sufficient understanding of the respective national language(s) to answer questionnaires and participate in MT
You may not qualify if:
- documented mental illness or cognitive impairment that prevents them from being able to complete the study intervention or outcome assessments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NORCE Norwegian Research Centre ASlead
- Haukeland University Hospitalcollaborator
- University Hospital, Akershuscollaborator
- Oslo University Hospitalcollaborator
- Meir Medical Centercollaborator
- Clinica de La Mujercollaborator
- University of Haifacollaborator
- University of Gdanskcollaborator
- King's College Londoncollaborator
- Universidad de Ciencias Empresariales y Socialescollaborator
- Szpital Miejski w Rudzie Śląskiejcollaborator
- SONO - Centro de Musicoterapiacollaborator
- Hospital Materno Infantil Ramón Sardácollaborator
- Hospital Fernandezcollaborator
Study Sites (10)
Hospital Materno Infantil Ramón Sardá
Buenos Aires, Buenos Aires F.D., 1246, Argentina
Sanatorio Mater Dei
Buenos Aires, Buenos Aires F.D., C1425DND, Argentina
Hospital Fernandez
Buenos Aires, Argentina
Clinica de la Mujer
Bogotá, Colombia
Fundación Santa Fe de Bogotá
Bogotá, Colombia
Meir Medical Center
Kfar Saba, 4428164, Israel
Haukeland University Hospital, Barne-og ungdomsklinikken
Bergen, Hordaland, 5006, Norway
Akershus University Hospital
Oslo, Lørenskog, 1478, Norway
Oslo University Hospital, Rikshospitalet
Oslo, 0424, Norway
Szpital Miejski w Rudzie Śląskiej
Ruda Śląska, 41-703, Poland
Related Publications (7)
Bieleninik L, Ghetti C, Gold C. Music Therapy for Preterm Infants and Their Parents: A Meta-analysis. Pediatrics. 2016 Sep;138(3):e20160971. doi: 10.1542/peds.2016-0971. Epub 2016 Aug 25.
PMID: 27561729BACKGROUNDGhetti C, Bieleninik L, Hysing M, Kvestad I, Assmus J, Romeo R, Ettenberger M, Arnon S, Vederhus BJ, Soderstrom Gaden T, Gold C. Longitudinal Study of music Therapy's Effectiveness for Premature infants and their caregivers (LongSTEP): protocol for an international randomised trial. BMJ Open. 2019 Sep 3;9(8):e025062. doi: 10.1136/bmjopen-2018-025062.
PMID: 31481362BACKGROUNDBieleninik L, Kvestad I, Gold C, Stordal AS, Assmus J, Arnon S, Elefant C, Ettenberger M, Gaden TS, Haar-Shamir D, Havardstun T, Lichtensztejn M, Mangersnes J, Wiborg AN, Vederhus BJ, Ghetti CM. Music Therapy in Infancy and Neurodevelopmental Outcomes in Preterm Children: A Secondary Analysis of the LongSTEP Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2410721. doi: 10.1001/jamanetworkopen.2024.10721.
PMID: 38753331DERIVEDEttenberger M, Bieleninik L, Stordal AS, Ghetti C. The effect of paternal anxiety on mother-infant bonding in neonatal intensive care. BMC Pregnancy Childbirth. 2024 Jan 11;24(1):55. doi: 10.1186/s12884-023-06179-z.
PMID: 38212696DERIVEDGhetti CM, Gaden TS, Bieleninik L, Kvestad I, Assmus J, Stordal AS, Aristizabal Sanchez LF, Arnon S, Dulsrud J, Elefant C, Epstein S, Ettenberger M, Glosli H, Konieczna-Nowak L, Lichtensztejn M, Lindvall MW, Mangersnes J, Murcia Fernandez LD, Roed CJ, Saa G, Van Roy B, Vederhus BJ, Gold C. Effect of Music Therapy on Parent-Infant Bonding Among Infants Born Preterm: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2315750. doi: 10.1001/jamanetworkopen.2023.15750.
PMID: 37234006DERIVEDGaden TS, Gold C, Assmus J, Kvestad I, Stordal AS, Bieleninik L, Ghetti C. Treatment fidelity in a pragmatic clinical trial of music therapy for premature infants and their parents: the LongSTEP study. Trials. 2023 Mar 3;24(1):160. doi: 10.1186/s13063-022-06971-w.
PMID: 36869392DERIVEDGaden TS, Ghetti C, Kvestad I, Bieleninik L, Stordal AS, Assmus J, Arnon S, Elefant C, Epstein S, Ettenberger M, Lichtensztejn M, Lindvall MW, Mangersnes J, Roed CJ, Vederhus BJ, Gold C. Short-term Music Therapy for Families With Preterm Infants: A Randomized Trial. Pediatrics. 2022 Feb 1;149(2):e2021052797. doi: 10.1542/peds.2021-052797.
PMID: 34988583DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christian Gold, PhD
NORCE Norwegian Research Centre
- PRINCIPAL INVESTIGATOR
Claire Ghetti, PhD
Grieg Academy, University of Bergen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Data collectors (for self-reports) and assessors (for observational measures) will be trained in assessment procedures and blinded to participant allocation. This will be ensured by using assessors from a different ward and by asking participants not to reveal their treatment assignments. Success of blinding will be verified.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Professor
Study Record Dates
First Submitted
June 10, 2018
First Posted
June 20, 2018
Study Start
August 25, 2018
Primary Completion
December 31, 2020
Study Completion
August 31, 2022
Last Updated
November 22, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
To promote transparency and applicability of trial results and to facilitate re- analysis by other researchers while also protecting anonymity, de-identified individual patient data will be made available through the Norwegian Centre for Research Data (NSD).