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This study will compare if using a continuous milk warmer to warm breast milk compared to the standard method of warming breast milk in a hot water bath improves weight gain and feeding tolerance in infants born at 32 weeks gestation or less over a ten-day period. The standard method does not keep the breast milk at a consistent temperature during the feeding. A continuous milk warmer maintains the breast milk at body temperature throughout the feeding. It is unknown which method improves weight gain and feeding tolerance in very low birth weight infants.
The aim of this randomized prospective quasi-experimental study is to determine if providing body temperature breast milk feedings to very low birth weight infants through use of continuous milk warmer improves feeding tolerance and weight gain compared to a standard milk warming technique.
Warming breast milk in a hot water bath just prior to feeding prior to feeding in the neonatal intensive care unit is a common practice. However, little evidence is available to support a standard warming method. This method allows inconsistent temperatures at time of feeding and progressive cooling of the milk during the feeding. No published study used a continuous warming device that delivered milk at a consistent physiological temperature throughout the feeding. The continuous warmer externally heats milk in the tubing just posterior to the feeding tube to provide body temperature milk to the infant.
A convenience sample from the Children's Hospital at OU Medical Center of 50 very low birth weight infants will be randomly assigned to either the experimental or control group for ten days. The experimental group will receive warmed feedings through the duration of the feeding through the use of the Guardian Warmerâ„¢, a continuous milk warming device. A control group will receive breast milk feedings warmed using the standard milk warming methods. Feeding tolerance and weight gain over the ten-day period will be used to evaluate the effectiveness of continuous milk warming.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Standard method of warming breast milk in a hot water bath prior to feeding. |
|
| Treatment Guardian Milk Warmer (Medela TM) | Experimental | External continuous milk warmer that heats milk within the tubing just posterior to the feeding tube to provide milk at body temperature for feeding infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment Guardian Milk Warmer (Medela TM) | Other | Infants were randomized to receive prepared syringes of breast milk via the continuous milk warmer (treatment arm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Gain | Comparison of two groups for weight gain over time in grams | At study completion, 10 days. |
| Feeding Intolerance | Comparison of feeding tolerance between groups using a residual algorithm | At study completion, 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Head Circumference | frontal-occipital circumference in centimeters | At study completion, 10 days |
| Body Length | Length as measured in centimeters |
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Inclusion Criteria:
• Gestational age 28-32 weeks on full enteral feeding of breast milk
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kris Sekar, MD | OUHSC Dept of Pediatrics, Neonatal-Perinatal Medicine | Principal Investigator |
| Susan M Bedwell, DNP | Univeristy of Oklahoma, The Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma, The Children's Hospital | Oklahoma City | Oklahoma | 73104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8955912 | Background | Anderson CA, Berseth CL. Neither motor responses nor gastric emptying vary in response to formula temperature in preterm infants. Biol Neonate. 1996;70(5):265-70. doi: 10.1159/000244375. | |
| 7436507 | Background | Blumenthal I, Lealman GT, Shoesmith DR. Effect of feed temperature and phototherapy on gastric emptying in the neonate. Arch Dis Child. 1980 Jul;55(7):562-4. doi: 10.1136/adc.55.7.562. |
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized prospective quasi-experimental controlled trial
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|
| Control | Other | Standard warming procedure of breast milk in syringe prior to feeding. |
|
| At Study completion, 10 days |
| 23912021 | Background | Dumm M, Hamms M, Sutton J, Ryan-Wenger N. NICU breast milk warming practices and the physiological effects of breast milk feeding temperatures on preterm infants. Adv Neonatal Care. 2013 Aug;13(4):279-87. doi: 10.1097/ANC.0b013e31829d8c3a. |
| 3116191 | Background | Eckburg JJ, Bell EF, Rios GR, Wilmoth PK. Effects of formula temperature on postprandial thermogenesis and body temperature of premature infants. J Pediatr. 1987 Oct;111(4):588-92. doi: 10.1016/s0022-3476(87)80127-0. |
| 33427754 | Derived | Bedwell SM, Buster B, Sekar K. The Effect of a Continuous Milk Warming System on Weight Gain in Very Low Birth-Weight Infants: A Randomized Controlled Trial. Adv Neonatal Care. 2021 Aug 1;21(4):E86-E92. doi: 10.1097/ANC.0000000000000818. |