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

NCT03221855 | Completed Early Phase 1

• 1 other identifier: 13-0197
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breastfeeding

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  10 days

Study Arms (2)

Domperidone

ACTIVE COMPARATOR

Domperidone 10mg every 8 hours for 7 days.

Drug: Domperidone

Placebo

PLACEBO COMPARATOR

Placebo 10mg every 8 hours for 7 days.

Drug: Placebo

Interventions

Domperidone DRUG

Capsules 10mg orally each 8 hours for 7 days.

Also known as: Motilium

Domperidone

Placebo DRUG

Capsules 10mg orally each 8 hours for 7 days.

Also known as: Lactose capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Mothers who report a decrease in the production of depleted milk.
• Mothers who do not have sufficient milk production to supply the baby's demand, according to the amount prescribed in the medical prescription.
• Mothers who are able to swallow tablets.

You may not qualify if:

• Mothers with the virus HIV.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 5505133597670, Brazil

Location

Related Publications (10)

• Giugliani ER. [Breast-feeding in clinical practice]. J Pediatr (Rio J). 2000 Nov;76 Suppl 3:S238-52. doi: 10.2223/jped.161. Portuguese.

  PMID: 14676902 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.

  PMID: 11694683 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.

  PMID: 20816003 BACKGROUND

• Gabay MP. Galactogogues: medications that induce lactation. J Hum Lact. 2002 Aug;18(3):274-9. doi: 10.1177/089033440201800311.

  PMID: 12192964 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.

  PMID: 18081460 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.

  PMID: 11202662 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.

  PMID: 18507654 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.

  PMID: 18589449 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.

  PMID: 20008425 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.

  PMID: 10437667 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Interventions

Domperidone; Lactose

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Rita de Cassia C. Silveira

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: July 19, 2017
• Study Start: March 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

BR (1)