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| Name | Class |
|---|---|
| Canadian Nurses Foundation (CNF) | OTHER |
| Dalhousie University | OTHER |
The purpose of this study is to evaluate the effect of domperidone (given to lactating mothers of very preterm infants) on the macronutrient composition of human milk.
Domperidone, a drug that enhances upper gastric motility, is an anti-dopaminergic medication that also elevates prolactin levels. It has been shown to safely increase the milk supply of lactating women. To date, researchers have analyzed the effects of domperidone on lactating woman with respect to the quantity of their milk production, adverse effects, and drug levels in the breast milk. However, the effect of domperidone on the macronutrient composition of breast milk has not been studied and current guidelines for fortification of human milk for premature infants do not distinguish between those women using or those not using domperidone. The purpose of this study is to evaluate the effect of domperidone (given to lactating mothers of very preterm infants) on the macronutrient composition of human milk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Domperidone | Experimental | Domperidone |
|
| placeob- Sugar pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Domperidone | Drug | 10 mg po TID X 14 days |
| |
| Placebo- Sugar pill |
| Measure | Description | Time Frame |
|---|---|---|
| The protein levels from breast milk will be compared, between the two groups (taking into consideration the expected rate of decline associated with increasing postpartum days). | days 0, 4, 7, and 14 |
| Measure | Description | Time Frame |
|---|---|---|
| The fat, carbohydrate, lactose, energy, calcium, phosphorus and sodium content of breast milk will be compared between domperidone and placebo groups. | days 0, 4, 7, and 14, | |
| Breast milk volumes (if the infant breast feeds, volume will be estimated using pre and post feeding weights) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marsha L Campbell-Yeo, MN NNP-BC PhDc | IWK Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16719919 | Background | Campbell-Yeo ML, Allen AC, Joseph KS, Ledwidge JM, Allen VM, Dooley KC. Study protocol: a double blind placebo controlled trial examining the effect of domperidone on the composition of breast milk [NCT00308334]. BMC Pregnancy Childbirth. 2006 May 23;6:17. doi: 10.1186/1471-2393-6-17. | |
| 20008425 | Derived | Campbell-Yeo ML, Allen AC, Joseph KS, Ledwidge JM, Caddell K, Allen VM, Dooley KC. Effect of domperidone on the composition of preterm human breast milk. Pediatrics. 2010 Jan;125(1):e107-14. doi: 10.1542/peds.2008-3441. Epub 2009 Dec 14. |
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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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| ID | Term |
|---|---|
| D004294 | Domperidone |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| Drug |
placebo po TID x 14 days |
|
| Daily X 14 days |
| Serum prolactin level | Day 0, 4 and 14 |
| infant weights | daily X 14 days |
| breastfeeding rates | two weeks after treatment completion and at discharge |
| D000091642 | Urogenital Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |