Investigating the effect of domperidone on breast milk supply following preterm birth- the SUMMIT study
- Conditions
- actation insufficiencyPreterm birthLactation insufficiencyReproductive Health and Childbirth - Breast feedingReproductive Health and Childbirth - Complications of newborn
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 170
Mothers of preterm infants born <34 weeks' gestation (up to 33+6)
-Lactation insufficiency defined as breast milk volume less than 300 mL/day in previous 24 hours if between 7 and 13 days postpartum, or breast milk volume less than 500 mL/day in previous 24 hours if between 14 and 28 days postpartum.
-Between 7 and 28 days postpartum
-Expressing with an electric pump an average of 6 times a day or more in previous 24-48 hours
-Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessment and follow-up of mother and baby until infant discharge.
-Signed and written consent.
- Evidence of current Q-Tc prolongation (according to screening ECG)
- Already taking domperidone
- Allergy to domperidone
- 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
- Known chronic renal or hepatic impairment
- Contraindication to breastfeeding (e.g., HIV)
- Known to have a prolactin-releasing pituitary tumor
- Currently taking medications known to alter the metabolism and pharmacokinetics of domperidone and cause Q-Tc prolongation (e.g., oral azole antifungals, erythromycin antibiotics)
- Higher order pregnancies (triplet, or more)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method