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| Name | Class |
|---|---|
| Wake Forest University Health Sciences | OTHER |
| Medela AG | INDUSTRY |
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The temperature of milk fed to infants in the Neonatal Intensive Care Unit (NICU) has been shown to vary greatly, and is influenced by individual provider practice. The clinical effect of varying milk temperatures on preterm infant feeding tolerance has not been well studied. The purpose of this study is to examine the effect of warming method, water bath versus commercial warmer and its impact on feeding tolerance. Sample population will include eighty-six infants born at 30-0/7 weeks or less, and admitted to the Neonatal Intensive Care Unit at Advocate Children's Hospital, Park Ridge within 48 hours of birth and remain in the study for a minimum of 28 days. After obtaining consent, eligible infants will be assigned to a control (water bath) or experimental (commercial warmer) group using a randomized sampling scheme. After warming, and just prior to feeding, milk temperatures will be taken and recorded by a trained data recorder. Feeding tolerance will be measured based on gastric residual volume and length of time required to achieve full feeds. Based upon the available evidence, the study investigators hypothesize that warming feeds to a consistent temperature range using commercially available milk warmer will improve feeding tolerance and decrease time to full feedings in preterm infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard warming | No Intervention | Feeding warmed in water bath | |
| Commercial warmer | Experimental | Feedings warmed with a commercial warmer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feedings warmed with commercial warmer | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feeding intolerance | Feeding intolerance is defined by one or more of the following clinical observations:
| 168 completed feedings; approximately 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Full enteral feeding | The point in time that parenteral nutrition is discontinued based on the judgment that the infant's enteral intake is sufficient to continue growth and development. | approximately 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bonnie Satinover, BSN | Contact | 847-723-5386 | bonnie.satinover@advocatehealth.com | |
| Jeanne Wiesbrock, MS, BSN | Contact | 847-723-7046 | jeanne.wiesbrock@advocatehealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Children's Hospital, Park Ridge | Recruiting | Park Ridge | Illinois | 60068 | United States |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |