RecruitingACTRN12621000503820

Identifying predictors of breast milk supply following preterm birth- the PROMO study

Predictors Of Milk Output following preterm birth (PROMO)- a prospective cohort study


Sponsor

South Australian Health and Medical Research Institute (SAHMRI)

Enrollment

154 participants

Start Date

Jun 24, 2021

Study Type

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

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When a baby is born very early (before 34 weeks), establishing a good breast milk supply is important for the baby's health and development — but many mothers of premature babies find it extremely difficult to produce enough milk. This study, called PROMO, aims to identify what factors — biological, hormonal, lifestyle, and psychological — influence how much breast milk a mother produces in the first three weeks after a preterm birth. You may be eligible if you have given birth to a premature baby before 34 weeks of gestation, intend to provide breast milk, are within 7 days of giving birth, and have adequate English skills. Women who have a medical contraindication to breastfeeding (such as HIV) or who have had a higher-order multiple pregnancy (triplets or more) are not eligible. Participants complete questionnaires about their health, mental wellbeing, and feeding practices, and provide samples of breast milk, blood, urine, and stool at several time points until their baby is discharged home. The study is not testing a treatment — it is observational, gathering detailed data to identify the key drivers of milk supply, which could inform better support strategies for mothers of premature babies.

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

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)

Womens and Childrens Hospital - North Adelaide

SA, Australia

Flinders Medical Centre - Bedford Park

SA, Australia

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ACTRN12621000503820


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