Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates
Condition: Low Milk Supply
MeSH terms: Premature Birth
Intervention: Domperidone maleate; Placebo Tablet; Domperidone maleate
Intervention description: domperidone maleate tablet 10 mg orally three times daily for 28 days; placebo tablet 10 mg orally three times daily for 14 days; domperidone maleate tablet 10 mg orally three times daily for 14 days
Intervention MeSH terms: Domperidone; Maleic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: breastmilk; domperidone; preterm

Summary:

      The purpose of this study is to evaluate the safety and efficacy of Domperidone in those
      mothers who are identified as having difficulty with breast milk production to meet the
      nutritional needs of their infant in the neonatal intensive are unit hospitalization setting,
      and to determine how it should be considered in the care of mothers and their preterm infants
      without causing undesirable effects to either the mother or infant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  mothers of a preterm infant born < 30 completed weeks gestation (23 0/7-29 6/7 weeks)

          -  postpartum period of 7-21 days

          -  mechanically pumping a minimum average of 6 times a day in the 4-7 days prior to
             enrollment

          -  experiencing inadequate milk supply defined as providing < 100% of the average of the
             daily nutritional intake during the previous 72-hour period prior to enrollment based
             on a fluid intake of 250 mL/kg/d or experiencing a clinical reduction of approximately
             20% from a peak volume during the previous 72-hour period prior to enrollment

        Exclusion Criteria:

          -  history of known or suspected cardiac dysrhythmias (tachyarrhythmia, Q-Tc
             prolongation) or currently on an anti-arrhythmic medication

          -  currently experiencing mastitis

          -  previous breast surgery, including augmentation or reduction, nipple piercing and/or
             the use of nipple rings/studs within the last year, or any reduction

          -  known chronic or debilitating illness, known abnormal liver function or gastric
             abnormalities gastrointestinal that will be exacerbated by the use of a prokinetic,
             examples include hemorrhage or blockage, actively treated with acid reflux which
             requires treatment for greater than 5 days and includes H2 blockers (occasional use of
             H2 blockers for heartburn or mild acid reflux is not considered an exclusion) and HIV

          -  known to have a prolactin-releasing pituitary tumor

          -  receiving medications known to alter the metabolism and pharmacokinetics of
             domperidone (eg. oral "azole" antifungals, erythromycin antibiotics, monoamine oxidase
             inhibitors (MAO) inhibitors) or medications that have dopaminergic or antidopaminergic
             activity or affect prolactin levels

          -  mothers of higher order pregnancies (triplet, or more)

          -  currently smoking 6 or more cigarette per day as reported by the mother