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Relaxation Intervention to Improve Newborn Growth and Maternal Well-being

RecruitingNAAges 0 Days - anyAllUniversity of California, San Francisco
NCT07774793 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if listening to a relaxation audiorecording during breastfeeding improves breastfeeding and infant outcomes and maternal well-being in a low-income country setting. The main questions it aims to answer are: * Does listening to a relaxation audiorecording during breastfeeding improve infant growth? * Does listening to a relaxation audiorecording during breastfeeding reduce maternal stress and anxiety? Researchers will compare listening to an audiorecording on a digital recording device to receiving the digital recording device without an audiorecording to see if relaxation audiorecordings work to improve breastfeeding, infant growth and maternal well-being. Participants will: * Listen to an audiorecording twice daily while breastfeeding for 12 weeks * Have study visits at 1, 2, 4 and 12 weeks for checkups and tests * Let us know what they th

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📋 Eligibility rules (as published)
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
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What it tests

  • Relaxation audiorecording
  • Control audio device without relaxation audiorecording
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Where

1 site
Makerere University School of Public Health
Kampala, Uganda
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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