Relaxation Intervention to Improve Newborn Growth and Maternal Well-being

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0+
SponsorUniversity of California, San Francisco

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

100 Participants
are divided into 2 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