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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
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
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Increase in Breast Milk Production
The primary outcome is the difference in the proportion of women having a 50% increase in breast milk volume at the end of 14 days of treatment with domperidone compared to mothers receiving placebo (mean day 14 volume minus mean day 0 volume at entry).
Time frame: Day 0 to day 14
Increase in Breast Milk Volume on Day 28
Number of mothers who achieved 50% increase in milk volume on day 28
Time frame: day 0 to day 28
Mean Breast Milk Volumes on Day 14
Mean milk volumes between the two groups at 14 days of study intervention
Time frame: Day 0 and day 14
Mean Breast Milk Volumes on Day 28
Mean milk volumes between the two groups at 28 days of study intervention
Time frame: day 0 and 28
Mean Volume Change From Day 0 to Day 14
change on the volume of milk from day 0 to day 14 between the two groups
Time frame: days 0 and 14
Mean Volume Change on the Volume of Milk From Day 15 to Day 28
change on the volume of milk from day 15 to day 28 between the two groups
Time frame: day 15 and day 28
Provision of Breast Milk at Term Gestation
provision of breast milk as the primary source of nutrition
Time frame: term gestation
Provision of Breast Milk at 6 Weeks Post Term Gestation
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Provision of breast milk at 6 weeks post term gestation as primary source of nutrition
Time frame: 6 weeks post term gestation