Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Hospital Pacifier Distribution on Breastfeeding Among Mothers at High Risk for Postpartum Depression

Conditions
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Breastfeeding, Postpartum Depression

Intervention / Treatment
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* Other: Pacifier


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Hours
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pacifier<br>Mother given a pacifier during birth hospitalization, along with other baby items | Other: Pacifier<br>* Pacifier given to mom.<br>|
| No Intervention: Control<br>Mother not given a pacifier, just the other baby items | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant Feeding - Breastfeeding Status | Mode of infant feeding: yes or no | up to 24 weeks | 
| Infant Feeding - Breastfeeding Duration | Breastfeeding duration overall (number of weeks mothers breastfed exclusively and at all) | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pacifier Use | Any use and frequency in the last 24 hours (7-point Likert scale) | 2, 4, and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacifier