Identifying predictors of breast milk supply following preterm birth- the PROMO study
Predictors Of Milk Output following preterm birth (PROMO)- a prospective cohort study
South Australian Health and Medical Research Institute (SAHMRI)
154 participants
Jun 24, 2021
Observational
Conditions
Summary
The primary objective of this study is to identify factors influencing breast milk volume in the first three weeks postpartum following preterm birth. Women will be recruited within 168 hours of birth of an infant born < 34 weeks gestation. All participants will undertake regular study assessments including at baseline (0-168 hrs postpartum), day 7, 14, 21, 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 provide breast milk, blood, urine, stool and buccal cell swab samples. The primary outcome of the study is daily expressed breast milk volume on day 21 postpartum. This will be identified from expressed volume recorded over a 24-hour period.
Eligibility
Plain Language Summary
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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
Women who have given birth to a preterm infant at less than 34 weeks' completed gestation, and who intend to breastfeed, will be recruited between 0 and 168 hours following birth. Participants will be assessed at regular intervals for up to 36 months infant corrected age. All participants will undertake regular study assessments including at baseline (day 1-7), 7, 14, 21 post-birth, at infant discharge to home or term corrected (whichever comes first), one-month, three-months and six-months infant corrected age. A medical record audit will be conducted at 24-36 months corrected age. Study assessments at baseline, day 7, 14, 21 post-birth, and infant discharge/term corrected age will be conducted face-to-face, whereas one-month, three-month, and six-month study visits will be conducted by telephone. As part of the study, women will complete a breast milk diary until 21 days postpartum. Women will regularly undertake questionnaires evaluating demographics and lifestyle, breast health, milk expression, postnatal health, mental health and wellbeing, and infant feeding practices, anticipated to take 30-60 minutes at each session. Women will provide breast milk, blood, urine, stool and buccal cell swab samples, collected and processed by research staff.
Locations(2)
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ACTRN12621000503820