Use of Domperidone to Increase Milk Production in Mothers With Newborns in Neonatology

Summary

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.

Timeline

Start

2013-03

Primary completion

2015-12

Completion

2016-03

Publications

• Background Giugliani ER. [Breast-feeding in clinical practice]. J Pediatr (Rio J). 2000 Nov;76 Suppl 3:S238-52. doi: 10.2223/jped.161. Portuguese.
• Background Charpak N, Ruiz-Pelaez JG, Figueroa de C Z, Charpak Y. A randomized, controlled trial of kangaroo mother care: results of follow-up at 1 year of corrected age. Pediatrics. 2001 Nov;108(5):1072-9. doi: 10.1542/peds.108.5.1072.
• Background Zuppa AA, Sindico P, Orchi C, Carducci C, Cardiello V, Romagnoli C. Safety and efficacy of galactogogues: substances that induce, maintain and increase breast milk production. J Pharm Pharm Sci. 2010;13(2):162-74. doi: 10.18433/j3ds3r.
• Background Gabay MP. Galactogogues: medications that induce lactation. J Hum Lact. 2002 Aug;18(3):274-9. doi: 10.1177/089033440201800311.
• Background Anderson PO, Valdes V. A critical review of pharmaceutical galactagogues. Breastfeed Med. 2007 Dec;2(4):229-42. doi: 10.1089/bfm.2007.0013.
• Background da Silva OP, Knoppert DC, Angelini MM, Forret PA. Effect of domperidone on milk production in mothers of premature newborns: a randomized, double-blind, placebo-controlled trial. CMAJ. 2001 Jan 9;164(1):17-21.
• Background Wan EW, Davey K, Page-Sharp M, Hartmann PE, Simmer K, Ilett KF. Dose-effect study of domperidone as a galactagogue in preterm mothers with insufficient milk supply, and its transfer into milk. Br J Clin Pharmacol. 2008 Aug;66(2):283-9. doi: 10.1111/j.1365-2125.2008.03207.x. Epub 2008 Apr 21.
• Background Djeddi D, Kongolo G, Lefaix C, Mounard J, Leke A. Effect of domperidone on QT interval in neonates. J Pediatr. 2008 Nov;153(5):663-6. doi: 10.1016/j.jpeds.2008.05.013. Epub 2008 Jun 27.
• Background 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.
• Background Zavitsanos AP, MacDonald C, Bassoo E, Gopaul D. Determination of domperidone in human serum and human breast milk by high-performance liquid chromatography-electrospray mass spectrometry. J Chromatogr B Biomed Sci Appl. 1999 Jun 25;730(1):9-24. doi: 10.1016/s0378-4347(99)00163-2.

Drugs

Indications

No indication recorded.