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

Preterm Birth Clinical Trial

— LongSTEP  

Official title:

Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers: International Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03564184
• Other study ID #: RCN 273534
• Status: Completed
• Phase: N/A
• Start date: August 25, 2018
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2022
• Source: NORCE Norwegian Research Centre AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: August 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Behavioral:
• MT during NICU
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.
• MT after NICU
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.

Other:
• Standard care
Includes necessary medical care and standard supportive interventions offered as part of care during hospitalization, and standard follow-up procedures post-hospitalization.

Locations

Country	Name	City	State
Argentina	Hospital Fernandez	Buenos Aires
Argentina	Hospital Materno Infantil Ramón Sardá	Buenos Aires	Caba
Argentina	Sanatorio Mater Dei	Buenos Aires	Caba
Colombia	Clinica de la Mujer	Bogotá
Colombia	Fundación Santa Fe de Bogotá	Bogotá
Israel	Meir Medical Center	Kfar Saba
Norway	Haukeland University Hospital, Barne-og ungdomsklinikken	Bergen	Hordaland
Norway	Akershus University Hospital	Oslo	Lørenskog
Norway	Oslo University Hospital, Rikshospitalet	Oslo
Poland	Szpital Miejski w Rudzie Slaskiej	Ruda Slaska

Sponsors (14)

Lead Sponsor	Collaborator
NORCE Norwegian Research Centre AS	Clinica de La Mujer, Haukeland University Hospital, Hospital Fernandez, Hospital Materno Infantil Ramón Sardá, King's College London, Meir Medical Center, Oslo University Hospital, SONO - Centro de Musicoterapia, Szpital Miejski w Rudzie Slaskiej, Universidad de Ciencias Empresariales y Sociales, University Hospital, Akershus, University of Gdansk, University of Haifa

Countries where clinical trial is conducted

Argentina,  Colombia,  Israel,  Norway,  Poland, 

References & Publications (2)

Bieleninik L, Ghetti C, Gold C. Music Therapy for Preterm Infants and Their Parents: A Meta-analysis. Pediatrics. 2016 Sep;138(3). pii: e20160971. doi: 10.1542/peds.2016-0971. Epub 2016 Aug 25. Review. — View Citation

Ghetti C, Bieleninik L, Hysing M, Kvestad I, Assmus J, Romeo R, Ettenberger M, Arnon S, Vederhus BJ, Söderström 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	12 months
Secondary	Child development	Bayley Scales of Infant and Toddler Development, 3rd edition (Bayley-III), standardized with a population mean of 100 (SD 15), with higher scores indicating better development	24 months
Secondary	Infant development	Ages and Stages Questionnaire, 3rd edition (ASQ-3), an age-specific parent-reported screening questionnaire consisting of 30 items, total sum score ranging from 0 to 300, with higher scores indicating better development.	12 months
Secondary	Infant socio-emotional development	Ages and Stages Questionnaire Social-Emotional (ASQ:SE), a parent-completed questionnaire with 19 or 22 Likert-scaled items (each 0-5-10), plus additional items for whether an item is of concern to the parent (each 0-5), resulting in a score ranging from 0-285 or 0-300, at 6 and 12 months respectively. Lower scores indicate better socio-emotional development.	12 months
Secondary	Re-hospitalization	Re-hospitalization excluding outpatient visits, based on electronic health records. This will be calculated as the time from initial discharge until first re-hospitalization.	12 months
Secondary	Maternal depression	Edinburgh Postnatal Depression Scale (EPDS), a 10-item validated self-report instrument assessing mothers' postpartum depressive symptoms, excluding somatic symptoms of depression that are common in new mothers (such as loss of energy, feeling tired, changes in appetite and sexual drive). Sum scores can range from 0 to 30, with high scores indicating more depressive symptoms.	12 months
Secondary	Parental anxiety	Generalized Anxiety Disorder Assessment (GAD-7), a self-report 7-item questionnaire serving as a screening tool and severity measure for generalized anxiety disorder. Sum scores can range from 0 to 21, with higher scores indicating higher anxiety.	12 months
Secondary	Parental stress	Parental Stress Scale (PSS), a self-report 18-item questionnaire that assesses stress associated with parenting. Sum scores can range from 18 to 90, with higher scores indicating higher stress.	12 months

External Links

•   Project website