Breastfeeding, Low Birth Weight, Undernutrition, Well-Being, Psychological
Conditions
Keywords
relaxation, audiorecording, breastfeeding, well-being, maternal-child health
Brief summary
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
Detailed description
Infant growth impairment is common in low-income countries and greatly increases the risk of adverse infant outcomes including infectious disease and cognitive impairment. Recently, randomized controlled trials in high-income countries have demonstrated that an audiorecording promoting relaxation during breastfeeding can improve growth for at-risk breastfeeding infants, perhaps by reducing maternal stress and improving maternal well-being. In this application, we propose to study whether such an intervention might be efficacious in a low-income country by conducting the randomized controlled trial, "Relaxation Intervention to Improve Newborn Growth and Maternal Well-being (RING-MW)," which will enroll 100 mothers and their LBW newborns hospitalized in a high-stress setting in Uganda, randomly assign them either to an audiorecording promoting relaxation during breastfeeding (intervention) or to usual care (control), and follow them at 1, 2, 4, and 12 weeks after birth to assess infant growth, adverse events, milk intake, feeding behavior, and maternal wellbeing.
Interventions
BEHAVIORALRelaxation audiorecording
This intervention will be an audiorecording on a digital audio device consisting of 15 minutes of relaxing messages supportive of breastfeeding.
BEHAVIORALControl audio device without relaxation audiorecording
Participants in the control group will receive a digital audio device that does not have a relaxation audiorecording
Sponsors
University of California, San Francisco
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Makerere University
Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Days to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight-for-age z-score (WAZ) | From birth through 12 weeks of age | Weight will be measured with the Seca 334 Infant Scale (Seca Inc., Wandsbek, Germany), which is portable for study visits at home or in hospital or clinic and is accurate to 5 grams. WAZ will be calculated from measured weight using the World Health Organization (WHO) Anthro Survey Analyser. Change in WAZ will be calculated by subtracting WAZ at birth from WAZ at 12 weeks of age. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding frequency | 1, 2, 4 and 12 weeks of age | Breastfeeding behavior including frequency and duration will be assessed |
| Any infant dietary intake other than human milk since last study visit | 1, 2, 4 and 12 weeks of age | Infant receipt of any feeding other than human milk since the last study visit will be assessed. We will query mothers about infant dietary intake since the last study visit including human breast milk, formula or any other feeding type such as juice or cow's milk. Infants who have received only human breast milk since the last study visit will be categorized as "no" for this outcome. Infants who have received any type of feeding other than human breast milk will be categorized as "yes" for this outcome. |
| Milk transfer | 1, 2, 4 and 12 weeks of age | Milk transfer from mother to infant will be measured in grams using the Breast Milk Intake Function of the Seca 334 Infant Scale. We will subtract the infant's pre-feeding weight (measured in grams) from the infant's post-feeding weight (measured in grams) to determine grams of milk transferred from mother to infant during the feeding. |
| Maternal stress | 1, 2, 4 and 12 weeks of age | Maternal stress will be measured at birth and at 4 and 12 weeks after birth using the Perceived Stress Scale (PSS), a tool which has been validated in the Ugandan postpartum population and which assesses participant stress over the past month. We will use the 10-item version of the PSS which has a minimum score of 0 and a maximum score of 40. Higher scores on the PSS are associated with increased stress. |
| Maternal anxiety | 2, 4 and 12 weeks after birth | Maternal anxiety will be measured at birth and at 2, 4 and 12 weeks after birth using the Generalized Anxiety Disorder 7-item scale (GAD-7), which has been validated for use in the Uganda. The GAD-7 has a minimum score of 0 and a maximum score of 21, with higher scores indicating higher levels of anxiety. The GAD-7 assesses participant anxiety over the past two weeks, so we will assess mothers using the GAD-7 at intervals no more frequent than 2 weeks. |
| Maternal depression | 1, 2, 4, and 12 weeks after birth | Maternal depression will be measured at 1, 2, 4, and 12 weeks after birth using the Edinburgh Postnatal Depression Scale (EPDS). The minimum score on the EPDS is 0 and the maximum score is 30, with higher scores indicating increased risk of depression. |
| sIgA | 2 and 4 weeks after birth | Secretory immunoglobulin A levels in breast milk will be assessed with enzyme-linked immunosorbent assay (ELISA) |
| IgG | 2 and 4 weeks after birth | Immunoglobulin G levels in breast milk will be assessed with enzyme-linked immunosorbent assay (ELISA) |
| Adverse events | 1, 2, 4 and 12 weeks after birth | Adverse events will be measured at 1, 2, 4 and 12 weeks after birth by querying participants regarding fever, difficulty feeding, difficulty breathing, cough, rash and diarrheal illness since the last study visit. |
| Fingertip temperature | 1, 2, 4 and 12 weeks after birth | For participants in the intervention group, fingertip temperature will be measured with the Gentle Temp 720 Thermometer (Omron, Inc.) before and after listening to the audiorecording intervention at each study visit. |
| Heart rate | 1, 2, 4 and 12 weeks after birth | For participants in the intervention group, heart rate will be measured with the BP7100 Series 3 (Omron, Inc.) before and after listening to the audiorecording intervention at each study visit. |
| Blood pressure | 1, 2, 4 and 12 weeks after birth | For participants in the intervention group, blood pressure will be measured with the BP7100 Series 3 (Omron, Inc.) before and after listening to the audiorecording at each study visit. |
| Actual use of the audiorecording | 1, 2, 4 and 12 weeks after enrollment | For participants in the intervention group, actual use of the audiorecording will be measured by self-report of how many times the audiorecording was used in the past 24 hours |
Countries
Uganda
Contacts
CONTACTVictoria Laleau, MS
PRINCIPAL_INVESTIGATORValerie Flaherman, MD, MPH
University of California, San Francisco
PRINCIPAL_INVESTIGATORVictoria Nankabirwa, PhD, MBBCh
Makerere University
Outcome results
None listed