Here is the design of a clinical trial:

Official Title: Determination of the Optimal Dose of Ephedrine in Intraoperative Arterial Hypotension of Newborns and Infants up to 6 Months of Age. A Randomized, Controlled, Open-label, Dose Escalation Study.

Included conditions:
- Intraoperative Arterial Hypotension
- Infant, Newborn

Study Armgroups:
- {'label': 'Ephedrine, dose : 0.6, 0.8, 1.0, 1.2 and 1.4 mg/kG', 'type': 'EXPERIMENTAL', 'description': 'Dose escalation: 6 successive cohorts with a maximal increasing dose', 'interventionNames': ['Drug: Ephedrine 30mg/10mL injectable solution, single administration, dose : 0.6, 0.8, 1.0, 1.2 and 1.4 mg/kG']}
- {'label': 'Ephedrine, dose : 0.1 mg/kG, reference dose', 'type': 'ACTIVE_COMPARATOR', 'description': 'Reference dose', 'interventionNames': ['Drug: Ephedrine 30mg/10mL injectable solution, single administration, dose : 0.1 mg/kG.']}

Interventions:
- {'type': 'DRUG', 'name': 'Ephedrine 30mg/10mL injectable solution, single administration, dose : 0.6, 0.8, 1.0, 1.2 and 1.4 mg/kG', 'armGroupLabels': ['Ephedrine, dose : 0.6, 0.8, 1.0, 1.2 and 1.4 mg/kG']}
- {'type': 'DRUG', 'name': 'Ephedrine 30mg/10mL injectable solution, single administration, dose : 0.1 mg/kG.', 'armGroupLabels': ['Ephedrine, dose : 0.1 mg/kG, reference dose']}

Primary Outcomes:
- {'measure': 'Therapeutic success is defined as a mBP superior to 55% of the basal mBP (prior to anesthesia) within 10 minutes post Ephedrine administration', 'timeFrame': 'Continuous monitoring within 10 minutes post-administration'}

Please estimate the sample size based on the assumption: 
The sample size was calculated to achieve a 95% confidence interval width between 0.18 and 0.29 for the probabilities of efficacy of each dose.
Sample size
        A total of 120 patients will be randomized, in 6 different cohorts with a maximal increasing dose.
        The distribution of subjects as proposed in Table 1 for each dose and cohort should allow to maximizing the precision of the estimation of the differences of efficacy of each dose, taking into account the cohort effect, which could be significant in this study. This proposal is conform to the description of Bailey [10].
        The sample size was calculated in terms of 95% confidence interval width of the probabilities of efficacy of each dose. The number of 120 subjects should allow width between 0.18 and 0.29, depending on the dose. These calculations are based on simulations performed using the R software; the hypotheses regarding the efficacy depending on the dose were based on results of the retrospective cohort on 141 subjects, considering a standard deviation of the cohort effect of 0.3 on a logarithmic scale of the odds of success.