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ImportanceParent-infant bonding contributes to long-term infant health but may be disrupted by preterm birth.ObjectiveTo determine if parent-led, infant-directed singing, supported by a music therapist and initiated in the neonatal intensive care unit (NICU), improves parent-infant bonding at 6 and 12 months.Design, Setting, and ParticipantsThis randomized clinical trial was conducted in level III and IV NICUs in 5 countries between 2018 and 2022. Eligible participants were preterm infants (under 35 weeks’ gestation) and their parents. Follow-up was conducted across 12 months (as part of the LongSTEP study) at home or in clinics. Final follow-up was conducted at 12 months’ infant-corrected age. Data were analyzed from August 2022 to November 2022.InterventionParticipants randomized to music therapy (MT) plus standard care or standard care alone during NICU admission, or to MT plus standard care or standard care alone postdischarge, using computer-generated randomization (ratio 1:1, block sizes of 2 or 4 varying randomly), stratified by site (51 allocated to MT NICU, 53 to MT postdischarge, 52 to both, and 50 to neither). MT consisted of parent-led, infant-directed singing tailored to infant responses and supported by a music therapist 3 times per week throughout hospitalization or 7 sessions across 6 months’ postdischarge.Main Outcome and MeasurePrimary outcome was mother-infant bonding at 6 months’ corrected age, measured by the Postpartum Bonding Questionnaire (PBQ), with follow-up at 12 months’ corrected age, and analyzed intention-to-treat as group differences.ResultsOf 206 enrolled infants with 206 mothers (mean [SD] age, 33 [6] years) and 194 fathers (mean [SD] age, 36 [6] years) randomized at discharge, 196 (95.1%) completed assessments at 6 months and were analyzed. Estimated group effects for PBQ at 6 months’ corrected age were 0.55 (95% CI, −2.20 to 3.30; P = .70) for MT in the NICU, 1.02 (95% CI, −1.72 to 3.76; P = .47) for MT postdischarge, and −0.20 (95% CI, −4.03 to 3.63; P = .92) for the interaction (12 months: MT in NICU, 0.17; 95% CI, −2.71 to 3.05; P = .91; MT postdischarge, 1.78; 95% CI, −1.13 to 4.70; P = .24; interaction, −1.68; 95% CI, −5.77 to 2.41; P = .42). There were no clinically important between-group differences for secondary variables.Conclusions and RelevanceIn this randomized clinical trial, parent-led, infant-directed singing did not have clinically important effects on mother-infant bonding, but was safe and well-accepted.Trial RegistrationClinicalTrials.gov Identifier: NCT03564184

OBJECTIVES To evaluate short-term effects of music therapy (MT) for premature infants and their caregivers on mother-infant bonding, parental anxiety, and maternal depression. METHODS Parallel, pragmatic, randomized controlled-trial conducted in 7 level III NICUs and 1 level IV NICU in 5 countries enrolling premature infants ( RESULTS From August 2018 to April 2020, 213 families were enrolled in the study, of whom 108 were randomly assigned to standard care and 105 to MT. Of the participants, 208 of 213 (98%) completed treatment and assessments. Participants in the MT group received a mean (SD) of 10 sessions (5.95), and 87 of 105 participants (83%) received the minimum of 6 sessions. The estimated group effect (95% confidence interval) for PBQ was −0.61 (−1.82 to 0.59). No significant differences between groups were found (P = .32). No significant effects for secondary outcomes or subgroups were found. CONCLUSIONS Parent-led, infant-directed singing supported by a music therapist resulted in no significant differences between groups in mother-infant bonding, parental anxiety, or maternal depression at discharge.