Table 2.

Participant timeline for SUMMIT

TIMEPOINT	STUDY PERIOD
	Baseline			Post-randomisation					Follow-up						Close-out
	Day 0			Day 7	Day 14	Day 21			Day 28			Infant discharge home/term CAa			24–36 months infant CA
ENROLMENT
Eligibility assessment/Informed consent	x
Randomisation	x
INTERVENTION
30 or 60 mg/day of domperidone	x			x	x	x
PRIMARY OUTCOME
Expressed breast milk volume on day 21						x
SECONDARY OUTCOMES
Participant Assessments
Maternal Electrocardiogram (ECG)	x			x
Daily Breast Milk Diary	x			x	x	x			x
Demographic/Lifestyle/Health	x
Postnatal Health				x	x	x			x			x
Breast Milk Expression/Breastfeeding	x			x	x	x			x			x
Breast Health	x			x	x	x			x
Breast Milk Expression Experience (BMEE)	x					x
Edinburgh Postnatal Depression Scale (EPDS)	x					x						x
Spielberger State-Trait Anxiety Inventory (STAI-6)	x					x						x
Parental Stressor Scale: NICU (PSS: NICU)	x											x
Maternal Postnatal Attachment Scale (MPAS)												x
Medical Record Data Extraction
Pregnancy/Birth History	x
Infant Feeding	x			x	x	x			x			x
Infant Growth and Anthropometric Measuresb	x			x	x	x			x			x
ANZNN Registry Data Extraction
Infant Morbidity												x
Bayley Scales of Infant Development (BSID)b;															x
Hearing/Vision Evaluationb															x
Maternal Biospecimens c
Blood Samples	x					x
Breast Milk Samples	x			x	x	x

Abbreviations: ANZNN, Australian and New Zealand Neonatal Network; CA, Corrected Age

^a Whichever time point occurs first

^b 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 developmental assessment

^c All biological samples are collected for research purposes and only at selected sites