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Randomized Clinical Trial: Use of Domperidone to Increase Milk Production in Mothers With Newborns Hospitalized in Neonatology
It is a double-blind randomized clinical trial placebo-controlled, which aims to assess whether Domperidone medication helps to increase milk production. The sample of 30 mothers of newborns in the Neonatal Intensive Care Unit of the Hospital de Clínicas de Porto Alegre for at least 15 days, receiving power enteral tube (without clinical condition for oral). Nursing mothers will be evaluated by the researcher (breastfeeding committee member) or consultants in breastfeeding that will advise these women about the practice of runs out of the breasts each mother. You receive containers for collection, at least one for each time you run out. These containers will measure the volume of milk. For each mother that refer insufficient milk production or is not maintaining adequate production for their newborn within 24 hours, one will be generated data form and after 15 days postpartum will be randomized and receive domperidone orally at a dose of 10mg 8/8 hours, or placebo in same volume. The milk volume will be measured daily. Three blood samples will be collected for each lactating each with 5 ml tube without anticoagulant for analysis of serum prolactin and domperidone. The sample 01 will be collected immediately after randomization, before receiving any medication (placebo x domperidone). The sample 02 on 5 of the study. And the sample 03, day 10 of the study, three days after the termination of the use of medication or placebo. A milk sample (5 ml) of each mother will be collected on day 5 to analysis of domperidone levels in milk. Once collected, the samples will be processed and frozen at -80o C for later analysis. All mothers will be followed until hospital discharge of their newborns, to monitor outcome breastfeeding exclusive breast.
Details
| Lead sponsor | Hospital de Clinicas de Porto Alegre |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | COMPLETED |
| Enrolment | 30 |
| Start date | 2013-03 |
| Completion | 2016-03 |
Conditions
- Breastfeeding
Interventions
- Domperidone
- Placebo
Primary outcomes
- Increase the production of breast milk of nursing mothers who are with their newborns admitted to the neonatal. Milk production measured by volume (ml) for 10 days. — 10 days
Increase the production of breast milk of nursing mothers who are with their newborns admitted to the neonatal, failing to provide this Baby breastfed during their hospital stay.
Countries
Brazil