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Table 1 Definition of population analysis sets

From: Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study): statistical analysis plan

Analysis population

HC treatment group

Placebo treatment group

Intention to treat ‘as randomised’

HC randomisation:

• Including all protocol deviations (e.g., in eligibility criteria)

Placebo randomisation:

• Including all protocol deviations (e.g., in eligibility criteria)

As treated ‘actual treatment’

Patient received HC (at least one dose), regardless of allocated treatment at randomisation:

• Including those infants who received rescue open-label corticosteroids as described according to protocol

• Including those infants who received rescue open-label corticosteroids not following protocol (protocol deviation)

• Including those infants with other protocol deviations (e.g., in eligibility criteria)

Patient received placebo (at least one dose), regardless of allocated treatment at randomisation:

• Including those infants not receiving any corticosteroid dose for pulmonary reasons

• Excluding those infants who received rescue open-label corticosteroids following study protocol

• Excluding those infants who received rescue open-label corticosteroids not following study protocol

• Including those infants with other protocol deviations (e.g., in eligibility criteria)

Per protocol

HC randomisation and treated according to study protocol:

• Including those infants receiving rescue open-label corticosteroids as described by the study protocol

• Excluding those infants receiving rescue open-label corticosteroids not according to study protocol (protocol deviation)

• Excluding other protocol deviations (e.g., in eligibility criteria)

Placebo randomisation and treated according to study protocol:

• Including those infants receiving rescue open-label corticosteroids following study protocol

• Excluding those infants receiving rescue open-label corticosteroids not following study protocol (protocol deviation)

• Excluding other protocol deviations (e.g., in eligibility criteria)

  1. HC hydrocortisone