Music and parental voice to support brain and language development in very preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-site randomized, controlled trial randomizing very preterm infants to receive music alone, music plus parent voice, or standard care while in the NICU. The team will measure acute and cumulative stress, brain intranetwork connectivity on term-equivalent MRI, and neurodevelopmental outcomes including language at two years corrected age. Infants born between 24+0 and 30+6 weeks' gestation who are medically stable at two level III NICUs are eligible, with parent questionnaires in English or Spanish. The trial compares immediate physiological and imaging markers with longer-term developmental outcomes to see if the interventions confer durable benefits.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Very preterm infants born between 24+0 and 30+6 weeks' gestational age (GA) from 2 level III NICUs (Brigham and Women's Hospital, Boston, MA and Yale New Haven, CT)
* Infants who are medically stable per the clinical care team

Exclusion Criteria:

* Infants with major genetic or congenital anomalies known to be associated with developmental delay
* Infants with severe brain injury (such as intraparenchymal hemorrhage, severe white matter injury)
* Infants who are severely ill infants for whom MBI is not feasible
* Infants of parents who cannot complete questionnaires in English or Spanish.

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Yale New Haven Hospital
  New Haven, Connecticut, United States Not yet recruiting

Study contacts

• Study coordinator: Carmina Erdei, MD
• Email: cerdei@bwh.harvard.edu
• Phone: 6174620202

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.