Survival without moderate or severe physiologic BPD at 36 weeks postmenstrual age. Moderate or severe physiologic BPD is defined as a requirement for supplemental oxygen and/or positive airway pressure to maintain oxygen saturation greater than 90 percent. A room air challenge was performed for infants estimated to be receiving less than 0.30 FiO2 by nasal cannula.

The analysis population includes all randomized infants with available data at hospital discharge.

Survival without moderate or severe neurodevelopmental impairment (NDI) at 22-26 months corrected age. NDI is defined as defined as any of: Bayley Scales of Infant and Toddler Development-III (Bayley-III) cognitive composite score less than 85 (standardized mean 100, SD 15, range 55-145) or motor composite score less than 85 (standardized mean 100, range 45-155) (lower scores indicating greater impairment), Gross Motor Function Classification System (GMFCS) level greater than or equal to II (on a scale from level I to V; I=normal and progressively higher levels indicate greater impairment), severe vision impairment in both eyes (consistent with refraction from less than 20 to 200), or bilateral hearing impairment with or without amplification (by report).

The analysis population includes all randomized infants with available data at the two-year followup.

Successful extubation during the intervention period, defined as remaining extubated for greater than or equal to 1 week, including greater than or equal to 3 days after the last dose of study medication. An extubation attempt was required after 72 hours of study drug and 24 hours after meeting the following: FiO2 less than 0.40 to maintain a saturation of greater than or equal to 88 percent, mean airway pressure less than 8 cm H2O, and hemodynamically stable in the opinion of the clinical team.

The analysis population includes all randomized infants with available data at hospital discharge.

Infant died before discharge home.

The analysis population includes all randomized infants with available data at hospital discharge.

BPD grade at 36 weeks postmenstrual age. BPD grades are defined as: 1. No support/room air; 2. Nasal cannula (NC) O2 less than or equal to 2L; 3. NC O2 greater than 2L or CPAP/NIPPV; 4. Invasive PPV

The analysis population includes all randomized infants with available data at hospital discharge.

Number of days on mechanical ventilation (using high frequency ventilator or conventional ventilator)

The analysis population includes all randomized infants with available data at hospital discharge.

Number of days of oxygen supplementation from birth to discharge home

The analysis population includes all randomized infants with available data who survived up to hospital discharge.

Number of days infant stayed in hospitals, among those who survived to discharge

The analysis population includes all randomized infants with available data at hospital discharge.

Infant received dexamethasone anytime before 36 weeks postmenstrual age.

The analysis population includes all randomized infants with available data at hospital discharge.

Severity of neurodevelopmental impairment, defined as one or more of: Bayley Scales of Infant Development-III (Bayley-III) cognitive score <85 (standardized mean 100, SD 15, range 55-145), Bayley-III motor score <85 (standardized mean 100, range 45-155), Gross Motor Function Classification System (GMFCS) level ≥2, severe vision impairment in both eyes (consistent with refraction <20-200), or bilateral hearing impairment with or without amplification (by report).

Bayley-III = Bayley Scales of Infant Development III (Cognitive score standardized mean 100, SD 15, range 55-145 motor score standardized mean 100, range 45-155; higher score indicates better performance (20))

The analysis population includes all randomized infants with available data who survived up to the two-year followup.

Number of infants with Gross Motor Function Classification System (GMFCS) level greater than or equal to II (on a scale from level I to V; I=normal and progressively higher levels indicate greater impairment)

The analysis population includes all randomized infants with available data who survived up to the two-year followup.

Number of infants with moderate or severe grade of cerebral palsy. Cerebral Palsy was diagnosed when there were definite abnormalities observed in the neuromotor exam, and functional challenges as classified by GMFCS level, and classified as moderate if GMFCS level was II or III and severe if level IV or V (40).

The analysis population includes all randomized infants with available data who survived up to the two-year followup.

Number of infants with bilateral hearing impairment with or without amplification (by report)

The analysis population includes all randomized infants with available data who survived up to the two-year followup.

Number of infants with severe vision impairment in both eyes (consistent with refraction less than 20-200)

The analysis population includes all randomized infants with available data who survived up to the two-year followup.

This is measured as the weight Z-score at 36 weeks postmenstrual age. The Z-score is derived using Fenton growth curves, and follows a standardized normal distribution with a mean 0. A z-score of 0 designates average weight, and negative scores denote less than average weight.

The analysis population includes all randomized infants with available data between 35 and 37 weeks at discharge.

This is measured as the weight Z-score at 22-26 months corrected age. The Z-score is determined using the WHO weight-for-age chart, and is derived from a standardized normal distribution, where 0 designates average weight-for-age, and negative scores denote less than average weight-for-age.

The analysis population includes all randomized infants with available data between 18 and 30 months at follow-up.

This is measured as the length Z-score at 36 weeks postmenstrual age. The Z-score is derived using Fenton growth curves, and follows a standardized normal distribution with a mean 0. A z-score of 0 designates average length, and negative scores denote less than average length.

The analysis population includes all randomized infants with available data between 35 and 37 weeks at discharge.

This is measured as the length Z-score at 22-26 months corrected age. The Z-score is determined using the WHO length-for-age chart, and is derived from a standardized normal distribution, where 0 designates average length-for-age, and negative scores denote less than average length-for-age.

The analysis population includes all randomized infants with available data between 18 and 30 months at follow-up.

This is measured as the head circumference Z-score at 36 weeks postmenstrual age. The Z-score is derived using Fenton growth curves, and follows a standardized normal distribution with a mean 0. A z-score of 0 designates average head circumference, and negative scores denote less than average head circumference.

The analysis population includes all randomized infants with available data between 35 and 37 weeks at discharge.

This is measured as the head circumference Z-score at 22-26 months corrected age. The Z-score is determined using the WHO head circumference-for-age chart, and is derived from a standardized normal distribution, where 0 designates average head circumference-for-age, and negative scores denote less than average head circumference-for-age.

The analysis population includes all randomized infants with available data between 18 and 30 months at follow-up.

BPD grade at 40 weeks postmenstrual age. BPD grades are defined as: 1. No support/room air; 2. Nasal cannula (NC) O2 less than or equal to 2L; 3. NC O2 greater than 2L or CPAP/NIPPV; 4. Invasive PPV

The analysis population includes all randomized infants with available data at hospital discharge.

Number of days on mechanical ventilation (using high frequency ventilator or conventional ventilator) up to status

The analysis population includes all randomized infants with available data who survived up to hospital discharge.

Number of days of oxygen supplementation from birth to 36 weeks post menstrual age

The analysis population includes all randomized infants with available data at hospital discharge.

Number of days on invasive PPV after postnatal day 14

The analysis population includes all randomized infants with available data who were extubated prior to hospital discharge.

Number of days of non-invasive PPV after postnatal day 14

The analysis population includes all randomized infants with available data who were extubated prior to hospital discharge.

Number of infants who received Inhaled glucocorticoids during the study intervention period

The analysis population includes all randomized infants with available data at hospital discharge.

Number of infants who received other systemic glucocorticoids during the study intervention period

The analysis population includes all randomized infants with available data at hospital discharge.

Number of days infant received dexamethasone anytime before 36 weeks postmenstrual age.

The analysis population includes all randomized infants with available data at hospital discharge.

Number of infants with a Patent Ductus Arteriosus (PDA) that was treated with medicine or surgery

The analysis population includes all randomized infants with available data at hospital discharge.

Number of infants diagnosed with Necrotizing Enterocolitis (NEC)

The analysis population includes all randomized infants with available data at hospital discharge.

Number of infants diagnosed with ROP stage 3 or worse in either eye. ROP stage 3 or worse is determined based on the extent of extraretinal fibrovascular proliferation. Higher stages of ROP indicate a worse outcome; the stages range from 1 for "mild" disease, to 5 for "severe" disease.

The analysis population includes all randomized infants with available data at hospital discharge.

Number of infants receiving therapy for Retinopathy of prematurity (ROP)

The analysis population includes all randomized infants with available data at hospital discharge.

Number of infants with severe IVH, grade 3 or 4. Severity of IVH is hierarchical. Grade 3 occurs when the ventricular size is enlarged and blood/echodensity is in the ventricle. Grade 4 occurs when blood/echodensity is in the parenchyma.

The analysis population includes all randomized infants with available data at hospital discharge.

Number of infants with Periventricular leukomalacia

The analysis population includes all randomized infants with available data at hospital discharge.

Number of infants with NDI. NDI is defined as defined as any of: Bayley Scales of Infant and Toddler Development-III (Bayley-III) cognitive composite score less than 85 (standardized mean 100, SD 15, range 55-145) or motor composite score less than 85 (standardized mean 100, range 45-155) (lower scores indicating greater impairment), Gross Motor Function Classification System (GMFCS) level greater than or equal to II (on a scale from level I to V; I=normal and progressively higher levels indicate greater impairment), severe vision impairment in both eyes (consistent with refraction less than 20-200), or bilateral hearing impairment with or without amplification (by report).

The analysis population includes all randomized infants with available data at the two-year followup.

Number of infants with a BSID-III cognitive composite score less than 85. (standardized mean 100, SD 15, range 55-145). Higher scores indicate better performance. Composite BSID-III scores of less than 85 are less than 1 standard deviation below the mean of 100.

The analysis population includes all randomized infants with available data at the two-year followup.

Number of infants with a BSID-III cognitive composite score less than 70. (standardized mean 100, SD 15, range 55-145). Composite BSID-III scores of less than 70 are less than 2 standard deviations below the mean of 100.

The analysis population includes all randomized infants with available data at the two-year followup.

Number of infants with a BSID-III motor composite score less than 85. (standardized mean 100, SD 15, range 55-145). Composite BSID-III scores of less than 85 are less than 1 standard deviation below the mean of 100.

The analysis population includes all randomized infants with available data at the two-year followup.

Number of infants with a BSID-III motor composite score less than 70. (standardized mean 100, SD 15, range 55-145). Composite BSID-III scores of less than 70 are less than 2 standard deviations below the mean of 100.

The analysis population includes all randomized infants with available data at the two-year followup.

Number of infants with cerebral palsy. Cerebral Palsy was diagnosed when there were definite abnormalities observed in the neuromotor exam, and functional challenges as classified by GMFCS level, and classified as moderate if GMFCS level was II or III and severe if level IV or V (40).

The analysis population includes all randomized infants with available data at the two-year followup.