Breastfeeding, Postpartum Depression
Conditions
Keywords
Pacifier
Brief summary
We will enroll 40 mother-infant dyads in a randomized trial exploring the effect of distribution of pacifiers during the birth hospitalization to mothers at high risk for postpartum depression on pacifier use, infant feeding, and maternal stress.
Detailed description
This study is a pilot a randomized controlled trial to determine if pacifier distribution affects breastfeeding among mothers at high risk for postpartum depression. We will recruit 40 mothers of healthy singleton births in a U.S. hospital who are at high risk of postpartum depression and randomly assign them to receive a pacifier or not. We will ascertain pacifier use, maternal stress, and infant feeding behaviors with web-based surveys at 2, 4, 6, 12, 18, and 24 weeks. Mothers will also wear a wristband to detect maternal heart rate variability throughout the first 6 weeks as a marker of maternal stress.
Interventions
OTHERPacifier
Pacifier given to mom.
Sponsors
Benedictine University
Yale University
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Hours to 45 Years
Healthy volunteers
No
Inclusion criteria
* Breastfeeding mother/infant dyad, receiving postpartum care at UC Davis Medical Center, maternal personal or family history of depression or postpartum depression, mother 18-45 years of age, infant 12-72 hours of age
Exclusion criteria
* infant without congenital anomalies that could affect feeding (cleft lip/palate, chromosomal anomaly, micro or retrognathia), infant preterm (born prior to 37 weeks' gestation), mother unable to participate in English, infant admitted to the neonatal intensive care unit, No smart phone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant Feeding - Breastfeeding Status | up to 24 weeks | Mode of infant feeding: yes or no |
| Infant Feeding - Breastfeeding Duration | up to 24 weeks | Breastfeeding duration overall (number of weeks mothers breastfed exclusively and at all) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pacifier Use | 2, 4, and 6 weeks | Any use and frequency in the last 24 hours (7-point Likert scale) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Maternal Stress | 2, 4, 6, 12, 18, and 24 weeks | Via Perceived Stress Scale (10 items, 5-point Likert scale) |
| Infant Feeding Efficiency | 2 and 6 weeks | Volume of breast milk or formula consumed via bottle within the first three minutes of feeding (mL/min); considered in the context of the infants' state (e.g., alert/awake, drowsy) and nipple size |
Countries
United States
Outcome results
None listed