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Completed

NCT Number: NCT03221855

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

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 5505133597670, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Domperidone

Drug

Capsules 10mg orally each 8 hours for 7 days.

Other names: Motilium

Placebo

Drug

Capsules 10mg orally each 8 hours for 7 days.

Other names: Lactose capsules

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.

    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.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jul 19, 2017
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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