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

July 17, 2017 updated by: Hospital de Clinicas de Porto Alegre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is a clinical double-blind randomized placebo-controlled trial. The sample consists of 30 mothers of newborns stable hemodynamically and are admitted to the Neonatal Intensive Care Unit of the Hospital de Clínicas de Porto Alegre for at least 15 days, receiving power via enteral tube (without clinical condition to oral). The mothers will be assessed by the researcher (committee member of breastfeeding) or a lactation consultants who will advise women about these practice runs out of the breasts. Breast milk is collected using a breast pump electric Lactinadouble, which enables the extraction of milk in both breasts simultaneously. Every mother receive collection containers, at least one for every time you run out. These containers will measure accurately the volume of milk. Women will be instructed to use a new packaging for each pumping and not add the milk from two different milkings. For every mother noted that insufficient milk supply or production is not suitable for keeping your newborn within 24 hours, it will generate an data form and after 15 days postpartum will be randomized and receive domperidone orally at a dose of 10mg of 8/8 hours or placebo in same volume. The mothers included in the survey will receive record sheets and adhesive labels to record the amount of milk collected, the date and time. The milk volume will be measured daily. Three blood samples will be collected for each nurse, each with 5 ml tube analysis without anticoagulant for serum levels of prolactin and domperidone. The sample 01 will be collected immediately after randomization, before receiving any medication (placebo x domperidone). The sample 02 at day 5 of the study. And the sample 03, the 10th day of the study, 3 days after the end of the medication or placebo.A milk sample (5 ml) of each mother will be collected on day 5 to analyzing levels of domperidone in the milk. Once collected, the samples will be processed and frozen at-80o C for later analysis. All mothers will be followed until discharge of their newborns, to monitor outcome breastfeeding exclusive breast.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 5505133597670
        • Hospital de Clinicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-Mothers with the virus HIV.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Domperidone
Domperidone 10mg every 8 hours for 7 days.
Drug: Domperidone
Capsules 10mg orally each 8 hours for 7 days.
Other Names:
  • Motilium
Placebo Comparator: Placebo
Placebo 10mg every 8 hours for 7 days.
Drug: Placebo
Capsules 10mg orally each 8 hours for 7 days.
Other Names:
  • Lactose capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Rita de Cassia C. Silveira, Hospital de Clinicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 16, 2016

First Submitted That Met QC Criteria

July 17, 2017

First Posted (Actual)

July 19, 2017

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 17, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-0197

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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