Clinical trial NCT03564184: Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers
Official title: Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers: International Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Keywords: Parent-infant bonding
Music therapy
Lead sponsor: NORCE Norwegian Research Centre AS
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: University Hospital, Akershus
name: Oslo University Hospital
name: Meir Medical Center
name: Clinica de La Mujer
name: University of Haifa
name: University of Gdansk
name: King's College London
name: Universidad de Ciencias Empresariales y Sociales
name: Szpital Miejski w Rudzie Śląskiej
name: SONO - Centro de Musicoterapia
name: Hospital Materno Infantil Ramón Sardá
name: Hospital Fernandez
First posted: 2018-06-20
Enrollment: 213
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 factorial, multinational, single-blind trial
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria (infants):

* 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

Inclusion Criteria (parents):

* 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

Exclusion Criteria (parents):

* documented mental illness or cognitive impairment that prevents them from being able to complete the study intervention or outcome assessments

Primary outcomes:
measure: Bonding between primary caregiver and infant
timeFrame: 6 months
Secondary outcomes:
measure: Bonding between primary caregiver and infant
timeFrame: 12 months
measure: Child development
timeFrame: 24 months
measure: Infant development
timeFrame: 12 months
measure: Infant socio-emotional development
timeFrame: 12 months
measure: Re-hospitalization
timeFrame: 12 months
measure: Maternal depression
timeFrame: 12 months
measure: Parental anxiety
timeFrame: 12 months
measure: Parental stress
timeFrame: 12 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Materno Infantil Ramón Sardá
state: Caba
city: Buenos Aires
country: Argentina
facility: Sanatorio Mater Dei
state: Caba
city: Buenos Aires
country: Argentina
facility: Hospital Fernandez
city: Bogotá
country: Colombia
facility: Clinica de la Mujer
city: Bogotá
country: Colombia
facility: Fundación Santa Fe de Bogotá
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Bergen
country: Norway
facility: Haukeland University Hospital, Barne-og ungdomsklinikken
state: Hordaland
city: Oslo
country: Norway
facility: Akershus University Hospital
state: Lørenskog
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
city: Ruda Śląska
country: Poland
facility: Szpital Miejski w Rudzie Śląskiej
Study officials:
affiliation: NORCE Norwegian Research Centre
name: Christian Gold, PhD
role: STUDY_CHAIR
affiliation: Grieg Academy, University of Bergen
name: Claire Ghetti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ghetti 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.
citation: Gaden 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.