NCT01512225

Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Low Milk Supply

Interventions

Type	Name	Description
DRUG	Domperidone maleate	domperidone maleate tablet 10 mg orally three times daily for 28 days
DRUG	Placebo Tablet	placebo tablet 10 mg orally three times daily for 14 days
DRUG	Domperidone maleate	domperidone maleate tablet 10 mg orally three times daily for 14 days

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-10-01
• Completion: 2016-03-01
• First posted: 2012-01-19
• Last updated: 2017-04-20
• Results posted: 2017-04-20

Locations

1 site across 1 country: Canada