Investigating the effect of domperidone on breast milk supply following preterm birth- the SUMMIT follow-up study
SUpporting Mothers Milk Intervention Trial comparing different doses of domperidone for treating lactation insufficiency in mothers of preterm infants: A Follow-Up study (Post-SUMMIT)
South Australian Health and Medical Research Institute (SAHMRI)
100 participants
Nov 4, 2022
Observational
Conditions
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 study follows the mothers and infants that have participated in the SUMMIT randomized controlled trial, and aims to compare the impact of two doses of domperidone on long-term breastfeeding, child growth and neurodevelopment up to 24-36 months infant corrected age. Eligibility participants will be mothers of preterm infants (< 34 weeks' gestation at birth), with insufficient breast milk (<300 mL/day or < 500 mL/day depending on postnatal age), who are expressing an average of six times a day or more, between 7 to 28 days postpartum, and who participated in the SUMMIT trial. Eligible women were randomised to receive high dose (60 mg/day) or low dose (30 mg/day) domperidone for 21 days.
Eligibility
Inclusion Criteria7
- All women who participated in the SUMMIT trial will be invited to participate. Selection criteria for SUMMIT include:
- 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 Criteria1
- Did not participate in SUMMIT RCT
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Interventions
This is a follow-up of the SUpporting Mothers Milk Intervention Trial (SUMMIT) - A randomized controlled trial comparing different doses of domperidone for treating lactation insufficiency in mothers of preterm infants. In the original study women were allocated to either receive domperidone 30 mg/day or 60 mg/day for 21 days. Follow-up of SUMMIT study participants (mothers and their infants) will occur until the infant reaches 24-36 months corrected age. Study visits will be undertaken at one-month, three-months and six-months infant corrected age. A medical record audit will be conducted between 24-36 months corrected age. Study assessments at one-month, three-months and six-months infant corrected age will be conducted by telephone. At each study visit women will complete questionnaires evaluating breastfeeding, breast health, maternal health, maternal mental health and wellbeing, as well as infant feeding practices and infant health, anticipated to take 30-60 minutes at each session.
Locations(6)
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ACTRN12621000512820