About this trial
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 think of the audiorecording
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Relaxation audiorecording
- Control audio device without relaxation audiorecording
Treatment groups
Sponsors and collaborators
University of California, San Francisco
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Makerere University
Collaborator
Cornell University
Collaborator