Use of Domperidone to Increase Milk Production in Mothers With Newborns in Neonatology
Condition: Breastfeeding
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): Domperidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules 10mg orally each 8 hours for 7 days.; Capsules 10mg orally each 8 hours for 7 days.
Other intervention name(s): Motilium; Lactose capsules
Intervention MeSH terms: Domperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment