Table 4.

Overview of data collected as part of the SUMMIT study

Study Assessments	Description
Participant Assessments
Maternal Electrocardiogram	Electrocardiogram (ECG) which records the electrical activity of the heart muscle and will display data on a trace, will be used as part of the Screening and Eligibility process to rule out clinically relevant pre-existing QT prolongation. A repeat ECG will also be conducted from day 6 to 15 post study medication start date. Each ECG will be reviewed by an adult Cardiologist. If QT prolongation (> 470 ms, Bazett’s formula [36]) or any other incidental cardiac abnormalities, is observed the participant and their General Practitioner will be notified.
Breast Milk Diary	Daily breast milk diary [37] recording the number of times each breast was expressed, the method used to express, the volume of expressed milk, duration and if applicable information pertaining to direct breastfeeding until at least seven days following the intervention phase (i.e. until at least 28 days after study enrolment). The breast milk diary will be commenced 24–48 h prior to randomisation to allow for baseline data to be collected. In addition, women will be asked to record medication doses taken (or missed) throughout the intervention period. Any adverse events can also be recorded in the diary.
General Information	Contact information, including name, address, phone number, email address, hospital ID number, secondary contacts and general practitioner details.
Demographic/Lifestyle/Health	Maternal age, height, pre-pregnancy weight, smoking status, alcohol intake, pre-existing medical conditions, ethnicity and Indigenous status, country of birth, languages spoken at home, combined household income status, workforce status, education level, marital status, previous pregnancy and breastfeeding history, pregnancy complications, medication use, postnatal contraception use, breast type/shape [40], breast development since puberty and during pregnancy [40]. Paternal ethnicity and Indigenous status, country of birth, workforce status, education level.
Postnatal Health	Postnatal health issues during the study (e.g. infections, cold/flu), as well as any medications (prescription or non-prescription), herbal supplements or multivitamins taken.
Breast Milk Expression/Breastfeeding	Breastfeeding values and intended duration of breastfeeding, breast development previous to and during pregnancy, time of first expressing following birth, perceived onset of lactogenesis, methods and type of breast milk expressing (including type of breast milk pump), duration of breast milk expressing or breastfeeding, and provision of lactation support.
Breast Health	Questionnaire adapted from Fetherston 2006 [41] to assess general breast health and mastitis risk. Includes data on breast fullness, breast pain and discomfort, duration of pain/discomfort, presence of cracks or grazes on the nipples, fever, as well as any areas of heat, swelling or redness on breasts.
Breast Milk Expression Experience (BMEE) Questionnaire	BMEE provides a measure of milk expression experience across three dimensions: (1) social support for milk expression; (2) ease of learning how to express milk; and (3) personal experiences of milk expression [42].
Mental health and wellbeing questionnaires • EPDS • STAI-6 • PSS: NICU • MPAS	Assessment of depression and anxiety symptoms will be collected using standardises validated questionnaires (Edinburgh Postnatal Depression Scale [EPDS] [43], Spielberger State-Trait Anxiety Inventory [STAI-6]) [44]. Stress related to infant hospitalisation will be assessed using the Parental Stressor Scale: NICU (PSS: NICU) [45]. Maternal-infant attachment will be assessed using the Maternal Postnatal Attachment Scale (MPAS) [46].
Medical Record Data Extraction
Pregnancy/Birth History	Previous pregnancy outcomes, method of conception for this pregnancy, antenatal anthropometrics, antenatal EPDS and Antenatal Risk Questionnaire (ANRQ) completion and scores, booking haemoglobin, ferritin, vitamin D, HbA1C and repeat haemoglobin, ferritin, vitamin D and oral glucose tolerance test (OGTT) at 28 weeks. Pregnancy complications and associated treatments (e.g., preterm premature rupture of membranes (PPROM), pre-term labour tocolytic use, antenatal corticosteroid use, pregnancy-induced hypertension, preeclampsia, HELLP, eclampsia, placental abruption, gestational diabetes mellitus, antepartum haemorrhage or intrauterine growth restriction. Labour and birth details including predelivery admission, onset of labour, mode of delivery, birthdate, gestation, analgesia for labour and/or caesarean section, active third stage management drugs, infant weight(s), retained placenta, placenta weight, estimated blood loss, perineal status, postpartum haemoglobin and ferritin, treatments for blood loss/anaemia, and Intensive Care Unit or High Dependency Unit admission. Antibiotic use prior to and during labour/delivery, antibiotic use following delivery and at discharge. Length of hospital admission.
Infant Feeding	Daily total enteral intake (expressed breast milk, donor breast milk, infant formula), parenteral intake, as well as proportion of enteral feeds consisting of mothers’ own breast milk.
Infant Growth and Anthropometric Measures	Daily record of anthropometrics (weight, length, head circumference) during admission.
ANZNN Registry Data Extraction [47][46]
Infant Morbidity	Infant morbidity data will be obtained from the Australian and New Zealand Neonatal Network (ANZNN) registry (maternal, perinatal and birth data, neonatal interventions and outcomes).
Bayley Scales of Infant Development (BSID)/ Hearing and Vision Evaluation	All infants born at less than 28 weeks’ gestation or less than 1,000 g at birth are routinely followed up at 2–3 years and undergo a neurological and development assessment. A standardised set of data collected and reported to the ANZNN will be obtained and includes BSID (Bayley-III or Bayley-4 (A&NZ)) developmental test results; growth, hearing and/or vision impairment.