CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 30 enrolled
Drug / intervention
Domperidone +1 moredrug
Likely dose
Domperidone 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03221855
NCT03221855Early Ph 1Completed

Randomized Clinical Trial: Use of Domperidone to Increase Milk Production in Mothers With Newborns Hospitalized in Neonatology

Hospital de Clinicas de Porto Alegre·interventional·Posted Jul 19, 2017·Updated Jul 19, 2017

In Brief

A Early Phase 1 clinical trial evaluating Domperidone and Placebo for Breastfeeding. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreastfeeding
CountriesBrazil
Collaborators--

Timeline

Early Ph 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 19, 2017
Enrollment StartMar 1, 2013
Primary CompletionDec 1, 2015
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.0 years ago

Interventions

Domperidonedrug

Capsules 10mg orally each 8 hours for 7 days.

Placebodrug

Capsules 10mg orally each 8 hours for 7 days.