Trial · NCT03169881
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bayley III Composite Cognitive Score | 22-26 months corrected age (a median of 25 months corrected age, which corresponds to a median of 29 months calendar age in the analysis population), unless the subject died earlier | Bayley Scale of Infant and Toddler Development (BSID)-III composite cognitive score, where subjects who died prior to the follow-up assessment are assigned the lowest possible score of 54. This is a standardized scale where a score that is more than 1 normative standard deviation from the normative mean of 100 signifies mild developmental delay (score \< 85); 2 standard deviations below the mean, moderate delay (score \< 70); and 3 standard deviations below the mean, severe delay (score \< 55). This self-standing scale comprises the primary outcome for the Darbe study. |
| Secondary | Number of Transfusions Per Infant | Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks) | The number of transfusions recorded during the study, up to 35 completed weeks gestational age |
| Secondary | Total Volume of Transfusions Per Infant | Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks) | The total volume of transfusions for the infant if ever transfused |
| Secondary | Number of Donor Exposures Per Infant | Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks) | The number of donor exposures recorded during the study, up to 35 completed weeks gestational age |
| Secondary | Hematocrit | at 2 and at 7 weeks in the study | Hematocrit adjusted for center, gestational age group, and familial clustering |
| Secondary | Red Cell Mass | at 2 and at 7 weeks in the study | Red Cell Mass (Circulating Erythrocyte Volume), adjusted for center, gestational age group, and familial clustering |
| Secondary | Necrotizing Enterocolitis, Bells Stage >=2 With Surgery | Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days) | This is measured as Yes if experienced necrotizing enterocolitis, Bells stage \>=2 with surgery; Otherwise, No. |
| Secondary | Bronchopulmonary Dysplasia Grades 2 or 3 | At 36 weeks postmenstrual age | This is measured as Yes if infant is on invasive mechanical ventilation, nasal cannula \>2 L/min or noninvasive positive airway pressure at 36 weeks of postmenstrual age; Otherwise, No. |
| Secondary | Retinopathy of Prematurity Stage >=3 or Treatment for That Condition Received | Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days) | This is measured as Yes if experienced Retinopathy of prematurity stage \>=3 or treatment for that condition received; Otherwise, No. Higher stages of ROP indicate a worse outcome; the stages range from 1 for "mild" disease, to 5 for "severe" disease. |
| Secondary | Intraventricular Hemorrhage Grade I+ | Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days) | This is measured as Yes if experienced Grade I+ Intraventricular Hemorrhage; Otherwise, No. |
| Secondary | Length of Hospital Stay | At initial hospital discharge or at death if it occurs earlier (a median of 94 days), assessed up to one year of life. | This is measured as the length of stay up to hospital discharge or death, whichever occurred first. |
| Secondary | Death | Birth, through the 22-26 months corrected age follow-up window, which corresponds to a median of 29 months calendar age in the analysis population | This is measured as Yes if an infant died between birth and 22-26 months corrected age; Otherwise, No. |
| Secondary | Neurodevelopmental Impairment | At 22-26 months corrected age (a median of 25 months corrected age) | This is a 4-level outcome, where Severe NDI denotes a BSID III cognitive score less than 70, a Gross Motor Functional (GMF) level of 3-5 (where higher scores indicate worse outcomes), blindness (less than 20/200 vision), and/or profound hearing loss, Moderate NDI denotes a BSID III cognitive score from 70-84 and either a GMF level of 2 or limited blindness / moderate hearing loss, Mild NDI denotes a BSID III cognitive score from 70-84, or a cognitive score \>=85 with a GMF level of 1 and/or mild hearing loss, and No NDI denotes a cognitive score \>= 85 and an absence of neurosensory deficits. |
| Secondary | Any Cerebral Palsy | At 22-26 months corrected age (a median of 25 months corrected age) | This is measured as Yes if the child has been deemed by the medical examiner as having Cerebral Palsy; Otherwise, No. |
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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