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To prevent unequal treatment-group sizes, the patients will be randomized according to a stratified block randomization method, in blocks of four.
In the population studied, the presence of multiple comorbidities introduces the possibility that patients in the cBMA Group with delayed healing had suboptimal numbers of progenitor cells in their cBMA sample; a larger sample size will be required as well as prior progenitor cell analysis so that patients can be randomized according to progenitor cell number.
In each group, patients will be randomized according to the study design.
Women who opt to take part will be randomized according to induction of labour or expectant management for spontaneous delivery.
Preterm newborns (gestational age at birth lower than 32 weeks) with stage 2 ROP (zone II-III without plus) will be randomized, according to their gestational age, to receive propranolol added to standard treatment (treatment adopted by the ETROP Cooperative Group) or standard treatment alone.
Term newborns (gestational age ≥ 36 weeks and birth weight ≥ 1800 g) with precocious metabolic, clinical and electroencephalographic (EEG) signs of hypoxic-ischemic encephalopathy will be randomized, according to their EEG pattern, to receive topiramate added to standard treatment with moderate hypothermia or standard treatment alone.
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Subjects were randomized according to a randomization scheme generated by the sponsor or their designee.
Infants were randomized according to a computer-generated random number table with random block sizes.
Patients were randomized according to a blinded randomization list held by the study coordinator.
The treatments were randomized according to a computer based randomization program.
Email addresses were randomized according to a computer generated random list.
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