Table 1

Schedule of interventions and assessments

Treatments and assessments	Registration	Day 0	Day 1	Day 3	Week 1	Week 2	Week 4	Week 12	Week 26	Week 38	Week 52	Week 78
Agreement	x
Demographics, current medications	x
Registration	x
Assignment	x
Administration		x
Hospitalisation
Vital signs*	x	x	x	x	x	x	x	x	x	x	x	x
Oxygen saturation	x	x	x	x	x	x	x	x	x	x	x	x
Haematological tests†	x	x	x	x	x	x	x	x	x		x	x
Biochemical tests‡	x	x	x	x	x	x	x	x	x		x	x
Urine analysis§	x	x	x		x	x
Composite endpoints
Spasticity								x	x	x	x	x
Postnatal development									x	x	x	x
Epilepsy
MRI	x					x						x
Bayley scale¶												x
Kyoto scale**												x
GMFCS												x

*Blood pressure, pulse rate and body temperature.
†Red cell count, haemoglobin, haematocrit, white cell count, white blood cell fraction (basophils, eosinophils, neutrophils, lymphocytes, monocytes) and platelet count.
‡Blood urea nitrogen, creatinine, lactate dehydrogenase, aspartate amino transferase, alanine amino transferase, alkaline phosphatase, gamma-glutamyl transpeptidase, total bilirubin, direct bilirubin, creatine kinase, C reactive protein, sodium, potassium, calcium, phosphorus and blood glucose level.
§pH, urine protein, urine occult blood and urine sugar.
¶Bayley Scales of Infant and Toddler Development Third edition.
**Kyoto Scale of Psychological Development 2001.
GMFCS, Gross Motor Function Classification System.