Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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It is widely acknowledged that recent perinatal and neonatal technological advances (eg. assisted ventilation, surfactant, antenatal corticosteroids) have greatly enhanced the survival rate of very low birth weight and extremely low birth weight infants. A compelling body of evidence now exists to suggest that use of breast milk to feed preterm infants during initial hospitalization positively impacts their neurodevelopment during early childhood and beyond. In order to provide breastmilk, mothers of preterm infants have to begin to produce and mechanically express milk. However, these mothers are often faced with challenges in maintaining an adequate volume that will meet their infants' nutritional needs, as well as declines in production after several weeks despite a myriad of measures designed to assist in production. The primary hypothesis for this study is that Domperidone, through its pharmacologic action on increasing prolactin levels, will assist mothers experiencing inadequate breast milk production in increasing breast milk volumes to a level identified as being sufficient for continued pumping in the hospitalization period.

Conditions

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Low Milk Supply

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Domperidone for days 1 to 28

Domperidone maleate tablets 10 mg orally three times daily from days 1 to 28

Group Type EXPERIMENTAL

Domperidone maleate

Intervention Type DRUG

domperidone maleate tablet 10 mg orally three times daily for 28 days

Placebo for days 1 to 14 and domperidone for day 15-28

Identical placebo tablets 10 mg orally three times daily from days 1 to 14 followed by Domperidone maleate tablets 10 mg orally three times daily from days 15 to 28

Group Type PLACEBO_COMPARATOR

Placebo Tablet

Intervention Type DRUG

placebo tablet 10 mg orally three times daily for 14 days

Domperidone maleate

Intervention Type DRUG

domperidone maleate tablet 10 mg orally three times daily for 14 days

Interventions

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Domperidone maleate

domperidone maleate tablet 10 mg orally three times daily for 28 days

Intervention Type DRUG

Placebo Tablet

placebo tablet 10 mg orally three times daily for 14 days

Intervention Type DRUG

Domperidone maleate

domperidone maleate tablet 10 mg orally three times daily for 14 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No