Trial period | ||||||||||
Enrolment | Allocation | Post allocation | Closeout | |||||||
Time point | -t1 | t0 | t1 | t2 | t3 | t4 | t5 | t6 | t7 | tx |
Enrolment | ||||||||||
Eligibility screen | x | |||||||||
Informed consent | x | |||||||||
Allocation | x | |||||||||
Interventions | ||||||||||
Smell and taste with tube feeding | ||||||||||
Routine care | ||||||||||
Assessments | ||||||||||
Baseline variables | x | x | ||||||||
Primary outcome | x | |||||||||
Secondary outcomes | x | x | x | x | x | x | x |
t1: before allocation; t0: time of allocation/randomisation; t1: time of full enteral feeds; t2: anthropometric data at 36 weeks' PMA; t3: time of discharge; t4: 3 months CA; t5: 6 months CA; t6: 1 year CA; t7: 2 years CA; tx: 2 years CA for infants eligible for the long-term follow-up programme, 1 year for infants not eligible for the follow-up programme but parents consented to be contacted for breast feeding rates, time of discharge home from hospital for all other infants.