An interventional study of MT during NICU and MT after NICU in Preterm Birth, sponsored by NORCE Norwegian Research Centre AS. Completed at 10 sites in 5 countries. Per ClinicalTrials.gov, last updated 2022-11-22.
Sponsored by NORCE Norwegian Research Centre AS · Not applicable, Interventional, and Treatment
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.
2,615 studies on the registry are indexed under Premature Birth; 507 are open to participants now.
This study's enrollment of 213 is above the median of 84 across 1,722 interventional studies indexed under Premature Birth.
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Inclusion Criteria (infants):
Inclusion Criteria (parents):
Exclusion Criteria (parents):
Consists of music therapy during NICU hospitalization, and music therapy after discharge from initial NICU hospitalization, along with standard care.
Behavioral: MT during NICU · Behavioral: MT after NICU · Other: Standard care
Consists of music therapy during NICU hospitalization, along with standard care.
Behavioral: MT during NICU · Other: Standard care
Consists of music therapy after discharge from initial NICU hospitalization, along with standard care.
Behavioral: MT after NICU · Other: Standard care
Consists of standard care.
Other: Standard care
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.
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).
Time frame: 6 months
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).
Time frame: 12 months
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
Time frame: 24 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
Plan to share: Yes — 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).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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NORCE Norwegian Research Centre AS