Here is the design of a clinical trial:

Official Title: Non-invasive Respiratory Support in Preterm Infants: a Multicentre Pilot Randomized Controlled Trial

Included conditions:
- Preterm Infant
- Respiratory Insufficiency Syndrome of Newborn
- Bronchopulmonary Dysplasia

Study Armgroups:
- {'label': 'High NCPAP', 'type': 'EXPERIMENTAL', 'description': 'Administration of high NCPAP (\\> 8 cmH2O) following either failure of traditional NCPAP pressures (≤ 8 cmH2O) OR post-extubation from high endotracheal mechanical ventilation settings (defined as mean airway pressure ≥10 cmH2O)', 'interventionNames': ['Other: Non-invasive respiratory support mode']}
- {'label': 'NIPPV', 'type': 'ACTIVE_COMPARATOR', 'description': 'Administration of NIPPV following either failure of traditional NCPAP pressures (≤ 8 cmH2O) OR post-extubation from high endotracheal mechanical ventilation settings (defined as mean airway pressure ≥10 cmH2O)', 'interventionNames': ['Other: Non-invasive respiratory support mode']}

Interventions:
- {'type': 'OTHER', 'name': 'Non-invasive respiratory support mode', 'description': 'A mode of providing respiratory support via nasal masks or prongs', 'armGroupLabels': ['High NCPAP', 'NIPPV']}

Primary Outcomes:
- {'measure': 'Ability to enroll a minimum of 10% of all eligible neonates per year at each site', 'description': 'Ability to enroll a minimum of 30% of all admitted neonates \\< 29 weeks GA who do not meet exclusion criteria AND ability to randomize a minimum of 33% of all enrolled patients per year at each site \\[i.e. randomize a minimum of 10% of all eligible neonates\\]', 'timeFrame': 'Through study completion (total 42 months)'}
- {'measure': 'Fewer than 20% randomized subjects with protocol violations in High CPAP arm', 'description': 'Defined as any use of NIPPV', 'timeFrame': 'Through study completion (total 42 months)'}
- {'measure': 'Fewer than 20% randomized subjects with protocol violations in NIPPV arm', 'description': 'Defined as any use of high NCPAP \\> 8 cmH2O', 'timeFrame': 'Through study completion (total 42 months)'}
- {'measure': 'Fewer than 20% of enrolled (consented, but pre-randomization) subjects with protocol violations', 'description': 'Defined as post-consent initiation of high NCPAP or NIPPV for \\>4 hours without randomization', 'timeFrame': 'Through study completion (total 42 months)'}

Please estimate the sample size based on the assumption: 
Not explicitly stated; this is a pilot trial to inform future studies.
Sample size
        For this multicentre pilot trial, a sample size of 100 subjects was determined based on the feasibility outcome outlined earlier (ie, ability to randomise a minimum of 10% of all patients <29âweekâs GA who do not meet exclusion criteria), as shown in online supplemental file. Analysis of secondary outcomes from this study will help inform the design and sample size for a larger, definitive trial.