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 evaluate the efficacy and safety of two commonly used galactagogues, Brewer’s yeast and beta-glucan, compared with placebo in improving maternal breast milk supply following preterm birth. Eligible women will be randomised to receive Brewer's yeast (1680 mg/day), Beta-glucan (250 mg/day) or placebo for 7 days, commencing within 72 hours of birth. The primary outcome will be assessed at day 7 following treatment initiation. All participants will undertake regular study assessments including at baseline (study enrolment), day 7 of treatment, postnatal day 21 and at infant discharge to home or term corrected (whichever comes first). 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 also undergo anthropometric assessment, and a breast milk, blood, urine, stool and buccal cell swab sample.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
- Infant born <34 weeks’ gestation (i.e. up to 33+6) - Intention to provide breast milk - Between 0 to 72 hours of birth - Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments - Adequate English language skills - Signed, written informed consent.
Exclusion criteria
- Contraindication to breastfeeding - Higher order pregnancies (triplet or more)