Relaxation audio during breastfeeding to help newborn growth and mom’s well-being
Official title: Randomized Controlled Trial of a Relaxation Intervention to Improve Newborn Growth and Maternal Well-being
Run by University of California, San Francisco · NCT07774793 · Data updated 2026-11-12
Researchers will test if listening to a relaxation audio during breastfeeding helps LBW babies grow and reduces maternal stress in a Ugandan setting.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Days and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (Kampala) |
| Status | Recruiting |
| Started | August 20, 2026 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT07774793 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Mothers of LBW newborns admitted to NICU in Uganda, breastfeeding initiated, and residing in the catchment area.
✕Probably not a fit
Families where mothers have hearing impairment or cannot speak Luganda, or infants not meeting weight/birth criteria, may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial will enroll 100 mothers and their LBW newborns in Uganda to see if a relaxation audiorecording played during breastfeeding improves infant growth, feeding behavior, and maternal well-being over 12 weeks. Participants are assigned to either receive the relaxation audio with an audio device or the device without the audio (control). They will listen twice daily during breastfeeding and return for visits at 1, 2, 4, and 12 weeks to assess growth, milk intake, adverse events, and maternal stress and anxiety. The study builds on prior findings from higher-income settings suggesting relaxation can benefit growth and maternal well-being, and tests applicability in a low-income, NICU-admitted population. Outcomes include growth measurements, feeding metrics, adverse events, and maternal well-being indicators.
Why it matters
Potential benefit: If successful, the intervention could improve infant growth and reduce maternal stress for families of low birth weight babies.
How similar studies have gone: Prior randomized trials in higher-income settings suggest relaxation during breastfeeding can improve infant growth and maternal well-being, but results in low-income settings are exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newborn low birth weight (LBW) (birth weight \< 2500 grams) * Newborn birth weight \>= 1800 g * Newborn admitted to Neonatal Intensive Care Unit (NICU) * Newborn in stable condition without WHO danger signs * Newborn age \<24 hours old * Breastfeeding initiated * Residence in the catchment area Exclusion Criteria: * Twins and other multiples * Newborn respiratory support or WHO danger signs * Newborn with major congenital anomaly or expected surgery * Contraindications to or unable to breastfeed * Mother with hearing impairment * Unable to speak Luganda
Where it's running
-
Makerere University School of Public Health
Kampala, Uganda Recruiting
Study contacts
- Principal investigator: Valerie Flaherman, MD, MPH — University of California, San Francisco
- Study coordinator: Victoria Laleau, MS
- Email: victoria.laleau@ucsf.edu
- Phone: 415-502-6266
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.