Study protocol: A double blind placebo controlled trial examining the effect of domperidone on the composition of breast milk [NCT00308334]

被引：10
作者：
Campbell-Yeo M.L. [1 ,2 ]
Allen A.C. [1 ,3 ]
Joseph K.S. [3 ]
Ledwidge J.M. [1 ]
Allen V.M. [3 ]
Dooley K.C. [4 ]
机构：
[1] Neonatal Intensive Care Unit, IWK Health Centre, Dalhousie University, Halifax, NS
[2] McGill University, Montreal, QC
[3] Perinatal Epidemiology Research Unit, Department of Obstetrics, Dalhousie University, Halifax, NS
[4] Laboratory Services, IWK Health Centre, Dalhousie University, Halifax, NS
来源：
BMC Pregnancy and Childbirth | / 6卷 / 1期
关键词：
Preterm Infant; Breast Milk; Metoclopramide; Neonatal Intensive Care Unit; Prolactin Level;
D O I：
10.1186/1471-2393-6-17
中图分类号：
学科分类号：
摘要：
Background: 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 breast milk. Methods/Design: Mothers of infants delivered at less than 31 weeks gestation, who are at least 3 weeks postpartum, and experiencing lactational failure despite non-pharmacological interventions, will be randomized to receive domperidone (10 mg three times daily) or placebo for a 14-day period. Breast milk samples will be obtained the day prior to beginning treatment and on days 4, 7 and 14. The macronutrient (protein, fat, carbohydrate and energy) and macromineral content (calcium, phosphorus and sodium) will be analyzed and compared between the two groups. Additional outcome measures will include milk volumes, serum prolactin levels (measured on days 0, 4, and 10), daily infant weights and breastfeeding rates at 2 weeks post study completion and at discharge. Forty-four participants will be recruited into the study. Analysis will be carried out using the intention to treat approach. Discussion: If domperidone causes significant changes to the nutrient content of breast milk, an alteration in feeding practices for preterm infants may need to be made in order to optimize growth, nutrition and neurodevelopment outcomes. © 2006 Campbell-Yeo et al; licensee BioMed Central Ltd.
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共 84 条
[1]  
Breastfeeding and the use of human milk, Pediatrics, 100, pp. 1035-1039, (1997)
[2]  
Nutrition for healthy term infants, J Paediatr Child Health, 3, pp. 109-112, (1998)
[3]  
Schanler R.J., Hurst N.M., Human milk for the hospitalized pre-term infant, Semin Perinatol, 18, pp. 476-486, (1994)
[4]  
Schanler R.J., Shulman R.J., Lau C., Feeding strategies for preterm infants: Beneficial outcomes feeding fortified milk versus preterm formula, Pediatrics, 103, pp. 1150-1157, (1999)
[5]  
Nutrient needs and feeding of premature infants, Can Med Assoc J, 152, pp. 1765-1784, (1995)
[6]  
Tudehope D.I., Steer P.A., Which milk for preterm infants?, J Paediatr Child Health, 32, pp. 275-277, (1996)
[7]  
Kuschel C.A., Harding J.E., Multi-component fortified human milk for promoting growth in preterm infants (Cochrane Review), The Cochrane Library, 4, (2000)
[8]  
Ehrenkranz R.A., Ackerman B.A., Metoclopramide effect on faltering milk production by mothers of premature infants, Pediatrics, 78, pp. 614-620, (1886)
[9]  
Brogden R.N., Carmine A.A., Heel R.C., Speight T.M., Avery G.S., Domperidone: A review of its pharmacological activity, pharmokinectics and therapeutic efficacy in the symptomatic treatment of chronic dyspepsia and as an antimetic, Drugs, 24, pp. 360-400, (1982)
[10]  
Kauppila A., Kivinen S., Ylikorkala O., A dose response relation between improved lactation and metoclopramide, Lancet, 1, pp. 1175-1177, (1981)
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