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

NCT ID: NCT03221855

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-03-31

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.

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.

Conditions

Breastfeeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Domperidone

Domperidone 10mg every 8 hours for 7 days.

Group Type: ACTIVE_COMPARATOR

Domperidone

Intervention Type: DRUG

Capsules 10mg orally each 8 hours for 7 days.

Placebo

Placebo 10mg every 8 hours for 7 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Capsules 10mg orally each 8 hours for 7 days.

Interventions

Domperidone

Capsules 10mg orally each 8 hours for 7 days.

Intervention Type: DRUG

Placebo

Capsules 10mg orally each 8 hours for 7 days.

Intervention Type: DRUG

Other Intervention Names

Motilium; Lactose capsules

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rita de Cassia C. Silveira

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

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Other Identifiers

13-0197

Identifier Type: -

Identifier Source: org_study_id