Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers: International Randomized Trial
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.


Options:
A: Arm Label: Early Vocal Contact; Type: EXPERIMENTAL; Interventions: Behavioral: Early Vocal Contact | Arm Label: Behavioral observation; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Behavioral Observation | Intervention Type: BEHAVIORAL; Name: Early Vocal Contact; Assigned to Arm(s): Early Vocal Contact | Intervention Type: BEHAVIORAL; Name: Behavioral Observation; Assigned to Arm(s): Behavioral observation
B: Arm Label: MT during and after NICU; Type: EXPERIMENTAL; Interventions: Behavioral: MT during NICU, Behavioral: MT after NICU, Other: Standard care | Arm Label: MT during NICU; Type: EXPERIMENTAL; Interventions: Behavioral: MT during NICU, Other: Standard care | Arm Label: MT after NICU; Type: EXPERIMENTAL; Interventions: Behavioral: MT after NICU, Other: Standard care | Arm Label: No MT; Type: EXPERIMENTAL; Interventions: Other: Standard care | Intervention Type: BEHAVIORAL; Name: MT during NICU; Assigned to Arm(s): MT during NICU, MT during and after NICU | Intervention Type: BEHAVIORAL; Name: MT after NICU; Assigned to Arm(s): MT after NICU, MT during and after NICU | Intervention Type: OTHER; Name: Standard care; Assigned to Arm(s): MT after NICU, MT during NICU, MT during and after NICU, No MT
C: Arm Label: Registry Cohort; Type: N/A; Interventions: Other: No Intervention | Intervention Type: OTHER; Name: No Intervention; Assigned to Arm(s): Registry Cohort
D: Arm Label: music therapy; Type: EXPERIMENTAL; Interventions: Procedure: Music Therapy | Arm Label: control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: Music Therapy; Assigned to Arm(s): music therapy

Answer: B