Here is the design of a clinical trial:

Official Title: Doxapram Versus Placebo in Preterm Newborns: An International Double Blinded Multicenter Randomized Controlled Trial

Included conditions:
- Apnea of Prematurity
- Respiratory Insufficiency

Study Armgroups:
- {'label': 'Doxapram', 'type': 'EXPERIMENTAL', 'description': "Blinded doxapram (2mg/ml, in glucose 5%) loading dose of 2.0 to 2.5 mg/kg administered in 5 to 10 minutes, followed by a continuous infusion of 0.5 - 1.0 mg/kg/hr ('www.kinderformularium.nl') as long as needed. Therapy is down titrated or stopped based on the patients' respiratory condition. If endotracheal intubation is needed study drug is stopped. After extubation study drug may be restarted. Switch to gastro-enteral administration is allowed if no iv-access is needed for other reasons.", 'interventionNames': ['Drug: Doxapram']}
- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo (glucose 5%) will also be administered with a loading dose and continuous infusion (in equal amounts of fluid as in experimental arm) by intravenous or gastro-intestinal infusion. The treatment protocol will be equal to the protocol in the doxapram arm.', 'interventionNames': ['Drug: Placebo']}

Interventions:
- {'type': 'DRUG', 'name': 'Doxapram', 'description': 'Loading dose and continuous doxapram infusion.', 'armGroupLabels': ['Doxapram'], 'otherNames': ['Dopram']}
- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Loading dose and continuous placebo infusion.', 'armGroupLabels': ['Placebo'], 'otherNames': ['Placebo (for Doxapram)']}

Primary Outcomes:
- {'measure': 'Death or severe disability', 'description': 'Disability will be defined as cognitive delay, cerebral palsy, severe hearing loss, or bilateral blindness. Cognitive delay will be defined as a Mental Development Index score of less than 85 on the Bayley Scales of Infant and Toddler Development, Bayley Score of Infant Development (BSID) III scores. Cerebral palsy will be diagnosed if the child had a non-progressive motor impairment characterized by abnormal muscle tone and decreased range or control of movements. The level of gross motor function will be determined with the use of the Gross Motor Function Classification System. Audiometry will be performed to determine the presence or absence of hearing loss. Blindness will be defined as a corrected visual acuity less than 20/200', 'timeFrame': '2 years corrected age'}

Please estimate the sample size based on the assumption: 
Alpha of 0.05, power over 80%, and a loss to follow-up rate of 10% per treatment arm.
Sample size calculation
          The sample size calculation is based on a cohort study that investigated the long-term neurodevelopmental outcome of preterm infants who received doxapram therapy compared to non-treated matched control patients [20]. This paper described that 30% of the doxapram-treated patients had the composite outcome death or neurodevelopmental delay at 2 years corrected age compared to 50.8% in the non-treated control patients. We therefore consider an absolute decrease of 15% in the composite outcome as clinically relevant, and we aim to reduce the outcome from 50 to 35% with a number needed to treat of around 7 patients. With an alpha of 0.05 and a power over 80%, a sample size of 170 patients is needed per treatment arm when we use a continuity correction. Because we expect approximately 10 patients to be part of twins and a loss to follow-up rate (excluding death) of 10% per treatment arm, the sample size is 198 patients per treatment arm, adding up to a total of 396 patients to be included. Next to the formal consent letter, an animation and flyer are designed providing additional study information to optimize consent and to reach the targeted sample size.