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A randomized controlled trial of impact of wearable, wireless breast pumps on how often and how much milk mothers of premature infants can pump.
Randomized, controlled crossover study design. Non-blinded. Mother of infants born at or below 29+6 weeks of gestation will be eligible once their infant is 28 or more days old. Mothers will be provided with a wearable, wireless breast pump in addition to their usual hospital grade pump. Wireless pumps can be used while cuddling their baby, driving too and from the hospital, caring for other children, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wearable wireless pump provided in week one | Other | Provision of a wearable, wireless pump in week one with support from a lactation specialist, standard of care in week two. |
|
| Wearable wireless pump provided in week two | Other | Standard of care in week one, provision of a wearable, wireless pump in week two with support from a lactation specialist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable wireless breast pump | Device | As above |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of pumping sessions per day | Number of milk pumping sessions per day | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of milk pumped per day | Volume of breast milk pumped per day | 7 days |
| Percentage of required volume pumped | Percentage of infants daily required milk volume which was pumped per day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erica Ortiz | Contact | 512-324-1085 | erica.ortiz@ascension.org |
| Name | Affiliation | Role |
|---|---|---|
| Alan Groves | University of Texas at Austin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascension Seton Medical Center | Recruiting | Austin | Texas | 78705 | United States |
IPD can be shared at the request of other investigators
12/02/2024, for 2 years
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| 7 days |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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