None listed
Conditions
Brief summary
Mothers of preterm infants often struggle to produce enough breast milk to meet the daily feed requirements of their infants, especially in the longer-term. This randomized multi-centre double-blind parallel controlled trial will resolve the issue of whether a higher dose of domperidone (60 mg/day) leads to greater improvements in maternal breast milk supply compared to a lower dose (30 mg/day), while also evaluating differences in adverse events, impacts on breast milk composition, and identifying predictors of treatment response to domperidone. Eligible women will be randomised to a high dose (60 mg/day) or low dose (30 mg/day) domperidone for 21 days. All women will initially commence on the low dose for 2-days before continuing with their assigned treatment dose for a further 19 days. The primary outcome will be assessed at day 21 following treatment initiation. After this point in time, women will be provided with the option to taper their dose to twice daily for four days and then once daily for three days, before stopping. All participants will undertake regular study assessments including at baseline (study enrolment), day 7, 14, 21 of treatment, one-week following intervention, and at infant discharge to home or term corrected (whichever comes first). Women will undergo a breast assessment by a lactation consultant or nurse/midwife, and complete a breast milk diary throughout the study. Women will regularly undertake questionnaires evaluating demographics and lifestyle, breast health, milk expression, postnatal health, mental health and wellbeing, and infant feeding practices. Women will provide breast milk, blood, urine, stool and buccal cell swab samples.
Interventions
Domperidone - 20 mg capsule administered orally three times daily (total daily dose = 60 mg/day)
Participants will initially commence on a low dose (10 mg three times daily, 30 mg/day) for 2 day before increasing to 60 mg/day for a further 19 days.
Total duration of intervention is 21 days.
Participants will then be provided the option of tapering their dose to twice daily for four days, and then once daily for three days, before stopping.
Medication adherence will be assessed using pill co
Domperidone - 20 mg capsule administered orally three times daily (total daily dose = 60 mg/day) Participants will initially commence on a low dose (10 mg three times daily, 30 mg/day) for 2 day before increasing to 60 mg/day for a further 19 days. Total duration of intervention is 21 days. Participants will then be provided the option of tapering their dose to twice daily for four days, and then once daily for three days, before stopping. Medication adherence will be assessed using pill counts.
Sponsors
South Australian Health and Medical Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-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.
Exclusion criteria
- 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)
Outcome results
None listed