Trial · NCT01353313
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 40
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) | From day of randomization to 36 weeks post menstrual age | 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. |
| Primary | Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI) | From day of randomization to 22-26 months corrected age | 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). |
| Secondary | Number of Participants With Successful Extubation | From day of randomization to day 14 post randomization | 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. |
| Secondary | Total Deaths Before Discharge | From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | Infant died before discharge home. |
| Secondary | Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade at 36 Weeks Postmenstrual Age | At 36 weeks postmenstrual age | 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 |
| Secondary | Days of Mechanical Ventilation to 36 Weeks Postmenstrual Age (PMA) | From birth to 36 weeks postmenstrual age | Number of days on mechanical ventilation (using high frequency ventilator or conventional ventilator) |
| Secondary | Duration of Oxygen Supplementation up to Status | From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | Number of days of oxygen supplementation from birth to discharge home |
| Secondary | Length of Hospital Stay in Days Among Survivors to Discharge | From birth up to one year | Number of days infant stayed in hospitals, among those who survived to discharge |
| Secondary | Number of Participants With Dexamethasone Given Before 36 Weeks Postmenstrual Age (PMA) | From birth to 36 weeks postmenstrual age | Infant received dexamethasone anytime before 36 weeks postmenstrual age. |
| Secondary | Number of Participants With Normal/Mild, Moderate or Severe/Profound NDI | At 22-26 months corrected age | 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)) |
| Secondary | Number of Participants With Gross Motor Function Greater Than or Equal to Level 2 | At 22-26 months corrected age | 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) |
| Secondary | Number of Participants With Moderate-severe Cerebral Palsy | At 22-26 months corrected age | 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). |
| Secondary | Number of Participants With Severe Hearing Impairment (by Report) | At 22-26 months corrected age | Number of infants with bilateral hearing impairment with or without amplification (by report) |
| Secondary | Number of Participants With no/Some Functional Vision | At 22-26 months corrected age | Number of infants with severe vision impairment in both eyes (consistent with refraction less than 20-200) |
| Secondary | Weight Growth Measure Following Extremely Preterm Birth | At 36 weeks post-menstrual age | 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. |
| Secondary | Follow-up Weight Growth Measure Following Extremely Preterm Birth | At 22-26 months corrected age | 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. |
| Secondary | Length Growth Measure Following Extremely Preterm Birth | At 36 weeks post-menstrual age | 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. |
| Secondary | Follow-up Length Growth Measure Following Extremely Preterm Birth | At 22-26 months corrected age | 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. |
| Secondary | Head Circumference Growth Measure Following Extremely Preterm Birth | At 36 weeks post-menstrual age | 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. |
| Secondary | Follow-up Head Circumference Growth Measure Following Extremely Preterm Birth | At 22-26 months corrected age | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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