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This study was not funded and is not going to be done.
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| Name | Class |
|---|---|
| Benedictine University | OTHER |
| Yale University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pacifier | Experimental | Mother given a pacifier during birth hospitalization, along with other baby items |
|
| Control | No Intervention | Mother not given a pacifier, just the other baby items |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacifier | Other | Pacifier given to mom. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pacifier Use | Any use and frequency in the last 24 hours (7-point Likert scale) | 2, 4, and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Stress | Via Perceived Stress Scale (10 items, 5-point Likert scale) | 2, 4, 6, 12, 18, and 24 weeks |
| Infant Feeding Efficiency | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Medical Center | Sacramento | California | 95817 | United States |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
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| ID | Term |
|---|---|
| D041361 | Pacifiers |
| ID | Term |
|---|---|
| D015370 | Infant Equipment |
| D004864 | Equipment and Supplies |
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| 2 and 6 weeks |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |