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Table 4 Overview of data collected as part of the BLOOM study

From: Effect of brewer’s yeast or beta-glucan on breast milk supply following preterm birth: the BLOOM study – protocol for a multicentre randomised controlled trial

Questionnaire or assessment

Description

Questionnaires/Assessment

 

General information

Contact information, including name, address, phone number, hospital ID number.

Maternal demographic and lifestyle information

Maternal age, height, pre-pregnancy weight, smoking status, alcohol intake, pre-existing medical conditions, ethnicity, country of birth, income status, education level, marital status, previous pregnancy and breastfeeding history, pregnancy complications, medication use, postnatal contraception use, breast type/shape, breast development since puberty and during pregnancy.

Breast milk diary

Daily breast milk diary 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 for a total of 21 days.

Breast milk expression

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

Questionnaire adapted from Fetherston 2006 to assess general breast health and potential risk for mastitis. Collects information 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.

Postnatal Health Questionnaire

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.

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], Spielberger State-Trait Anxiety Inventory [STAI-6]). Stress related to infant hospitalisation will be assessed using the Parental Stressor Scale: NICU (PSS: NICU). Maternal-infant attachment will be assessed using the Maternal Postnatal Attachment Scale (MPAS).

Maternal anthropometry

Maternal weight, height, waist circumference, hip circumference, and mid upper-arm circumference will be assessed.

Medication side-effects and adverse event

Recording any side-effects pertaining to potential adverse events or serious adverse events. Details encouraged to be recorded in breast milk diary too.

Case Note Data Extraction

 

Pregnancy and birth history

Gravida, parity, length of gestation, infant birthweight, infant sex, plurality, onset of labour, method of birth, estimated blood loss, pregnancy complications (i.e. gestational diabetes, gestational hypertension, pre-eclampsia), antenatal interventions (i.e. receipt of antenatal corticosteroids of magnesium sulphate), medication use, antenatal haematology (i.e. haemoglobin, iron studies).

Infant feeding record

Daily record of total enteral intake, volume of expressed breast milk, donor milk, or infant formula, as well as proportion of enteral feeds consisting of mothers’ own breast milk.

Infant anthropometry

Weight, length, head circumference.

Infant morbidity/mortality

Infant morbidity and mortality data will be obtained from the Australian and New Zealand Neonatal Network (ANZNN) [29] registry. Data include, number of days in hospital (to first discharge home), intraventricular haemorrhage (IVH), confirmed sepsis, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), surgical procedures and death during initial hospitalisation.