RecruitingACTRN12621000512820

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)


Sponsor

South Australian Health and Medical Research Institute (SAHMRI)

Enrollment

100 participants

Start Date

Nov 4, 2022

Study Type

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

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This is a long-term follow-up study for mothers and their premature babies who participated in the SUMMIT trial, which compared two doses of domperidone to increase breast milk supply. The aim of this follow-up is to understand the long-term effects of the two doses on how long breastfeeding continues, and on the child's growth and brain development up to 2 to 3 years of age. You are eligible to participate if you and your baby took part in the SUMMIT randomised trial. In that trial, you were the mother of a baby born before 34 weeks, experienced low milk supply between 7 and 28 days after birth, and were pumping at least 6 times per day. Participants are followed up with questionnaires and assessments about their child's feeding, growth, and neurodevelopment at key time points up to 24 to 36 months corrected age. This long-term data is important because it will show not just whether domperidone increased milk supply short-term, but whether any differences persist and ultimately benefit the child's health and development over the first years of life.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Womens and Childrens Hospital - North Adelaide

QLD,SA,VIC, Australia

Flinders Medical Centre - Bedford Park

QLD,SA,VIC, Australia

The Royal Women's Hospital - Parkville

QLD,SA,VIC, Australia

Mercy Hospital for Women - Heidelberg

QLD,SA,VIC, Australia

Royal Brisbane & Womens Hospital - Herston

QLD,SA,VIC, Australia

Monash Medical Centre - Clayton campus - Clayton

QLD,SA,VIC, Australia

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ACTRN12621000512820


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