Here is the design of a clinical trial:

Official Title: Does the Use of Higher Versus Lower Oxygen Concentration Improve Neurodevelopmental Outcomes at 18-24 Months in Very Low Birthweight Infants - The HiLo-Trial

Included conditions:
- Premature Infant
- Respiratory Distress Syndrome in Premature Infant
- Neurodevelopmental Outcome

Study Armgroups:
- {'label': '30% group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Infants in the 30% oxygen group will remain in 30% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is \\<85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age.\n\nIntervention: Infants randomized to the 30% oxygen group will receive 30% oxygen at birth for the first 5 minutes. At 5 minutes oxygen can be adjusted as needed.', 'interventionNames': ['Drug: 30% oxygen group']}
- {'label': '60% group', 'type': 'EXPERIMENTAL', 'description': 'Infants in the 60% oxygen group will remain in 60% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is \\<85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age.\n\nIntervention: Infants randomized to the 60% oxygen group will receive 60% oxygen at birth for the first 5 minutes. At 5 minutes oxygen can be adjusted as needed.', 'interventionNames': ['Drug: 60% oxygen group']}

Interventions:
- {'type': 'DRUG', 'name': '30% oxygen group', 'description': 'Infants in the 30% oxygen group will remain in 30% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is \\<85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age.\n\nIntervention: Infants randomized to the 30% oxygen group will receive 30% oxygen at birth for the first 5 minutes. At 5 minutes oxygen can be adjusted as needed.', 'armGroupLabels': ['30% group']}
- {'type': 'DRUG', 'name': '60% oxygen group', 'description': 'Infants in the 60% oxygen group will remain in 60% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is \\<85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age.\n\nIntervention: Infants randomized to the 60% oxygen group will receive 60% oxygen at birth for the first 5 minutes. At 5 minutes oxygen can be adjusted as needed.', 'armGroupLabels': ['60% group']}

Primary Outcomes:
- {'measure': 'Neurodevelopmental outcome at 24+/- 6 months', 'description': 'At 24+/- 6 months corrected age, the infants will be assessed using the Bayley Scales of Infant Development-3rd edition (Bayley-III). A score 85-114 will be classified as normal, and scores \\<70 (2 SD below the mean of 100) will define severe cognitive delay.', 'timeFrame': '24+/- 6 months of age'}
- {'measure': 'Hearing loss', 'description': 'Audiometry will be performed to assess the presence or absence of severe hearing loss.', 'timeFrame': '24+/- 6 months of age'}
- {'measure': 'Blindness', 'description': 'Blindness will be defined as a corrected visual acuity of \\<20/200.', 'timeFrame': '24+/- 6 months of age'}
- {'measure': 'Mortality', 'description': 'All cause mortality from birth until follow-up at 24+/- 6 months of age', 'timeFrame': 'From birth up to 24+/- 6 months of age'}

Please estimate the sample size based on the assumption: 
type I error of 5%, power of 80%, within-cluster within-period ICC of 0.034, within-cluster between-period ICC of 0.029, cluster size in each arm of 10-80 (unequal cluster period but equal cluster size), loss to follow-up rate of ~10%
Sample size {14}
        A sample size of 1200 (600 per group, adjusted for 10% loss of follow-up) infants has been determined based on: baseline outcome rate of 35% (18% mortality and 17% abnormal neurodevelopmental outcomes) [48], RRR of 25%, type I error of 5%, power of 80%, within-cluster within-period ICC of 0.034, within-cluster between-period ICC of 0.029, cluster size in each arm of 10â80 (unequal cluster period but equal cluster size), and loss to follow-up rate ofâ~â10%. ICCs were derived from existing data from the Canadian Neonatal Network sites [48]. With these assumptions, we will need up to 20 centers (clusters) to recruit 20â80 patients per arm (20â160/center) for a total of 1200 neonates at all sites.