Nutritional adequacy of a novel human milk fortifier from donkey milk in feeding preterm infants: study protocol of a randomized controlled clinical trial

Table 5 Synoptic table. T0: before starting the fortification; T1: day 7 after beginning the fortification (if level 3 of ADJ fortification) or as soon as level 3 is reached; T2: day 14 since beginning of fortification; T3: day 21 since beginning of fortification

	STUDY PERIOD
	Enrolment	Allocation	Post-allocation				Close-out
Timepoint			T0	T1	T2	T3
Enrolment:
Eligibility screen	X
Informed consent	X
Full patient history collection	X
Allocation		X
Intervention:
BUN			X	X	X	X
Albumin			X	X	X	X
Creatinine			X	X	X	X
Calcium			X	X	X	X
Phosphate			X	X	X	X
Alkaline Phosphatase			X	X	X	X
Weight			X	X	X	X
Lenght			X	X	X	X
Head circumference			X	X	X	X
Plasma Aminoacids			X			X
Urine Aminoacids			X			X
Urinary Metabolomic Profile			X			X
Calprotectin			X			X
pH			X	X	X	X
BE			X	X	X	X
HCO₃⁻			X	X	X	X
MII/pH						X
Gastric emptying time						X
Assesments
List other data variables							X
List other data variables							X

ISSN: 1475-2891