Trial · NCT01702805
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Death or Neurodevelopmental Impairment | Birth to 22-26 months corrected age | A composite outcome that measures the occurrence of death or neurodevelomental impairment between birth and 22-26 months corrected age. |
| Primary | Death | Birth to 22-26 months corrected age | This is measured as Yes if an infant died between birth and 22-26 months corrected age; Otherwise, No. |
| Primary | Neurodevelopmental Impairment | at 22-26 months corrected age | This is measured as Yes if any hearing impairment or visual impairment is noted, if severe or moderate cerebral palsy is noted, or if the cognitive score of the Bayley III score is more than 1 standard deviation below the average; Otherwise, No. |
| Primary | Cognitive Delay | at 22-26 months corrected age | This is measured as Yes if the Bayley Scale of Infant and Toddler Development (BSID)-III cognitive score is more than 1 standard deviation below the average; Otherwise, No. |
| Primary | Moderate or Severe Cerebral Palsy | at 22-26 months corrected age | This is measured as Yes if the Gross Motor Function Classification System (GMFCS) score is level II or higher; Otherwise, No. Higher values of the GMFCS are worse than lower values; a level of "I" denotes mild cerebral palsy (CP); level "II" or "III" moderate CP; level "IV" or "V" severe CP. |
| Primary | Severe Vision Impairment | at 22-26 months corrected age | This is measured as Yes if the corrected visual acuity in the better eye of less than 20/200; Otherwise, No. |
| Primary | Severe Hearing Impairment | at 22-26 months corrected age | This is measured as Yes if bilateral hearing loss occurred for which hearing aids or cochlear implants were warranted; Otherwise, No. |
| Secondary | Survival to Discharge Without Severe Complications | Birth to initial hospital discharge or to death if it occurs earlier (a median of 97 days) | This is measured as Yes if survived to discharge without severe morbidity, defined as bronchopulmonary dysplasia, retinopathy of prematurity (stage 3 or higher or requiring treatment), or serious brain abnormality; Otherwise, No. |
| Secondary | Bronchopulmonary Dysplasia, Diagnosed on the Basis of the Need for Supplemental Oxygen After a Standardized Oxygen Reduction Test at 36 Weeks of Postmenstrual Age | at 36 weeks postmenstrual age | This is measured as Yes if experienced bronchopulmonary dysplasia, diagnosed on the basis of the need for supplemental oxygen after a standardized oxygen reduction test 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 97 days) | This is measured as Yes if experienced Retinopathy of Prematurity (ROP) Stage \>=3 or received treatment for that condition; Otherwise, No. Higher stages of ROP indicate a worse outcome; the stages range from 1 for "mild" disease, to 5 for "severe" disease. |
| Secondary | Grade 3 or 4 Intraventricular Hemorrhage, Cystic Periventricular Leukomalacia, or Ventriculomegaly Diagnosed on Ultrasonographic Examination | Birth to initial hospital discharge or to death if it occurs earlier (a median of 97 days) | This is measured as Yes if experienced Grade 3 or 4 intraventricularhemorrhage, cystic periventricular leukomalacia, or ventriculomegaly diagnosed on ultrasonographic examination; Otherwise, No. |
| Secondary | Necrotizing Enterocolitis, Bell's Stage >=2 | Birth to initial hospital discharge or to death if it occurs earlier (a median of 97 days) | This is measured as Yes if experienced necrotizing enterocolitis (NEC), Bell's stage \>=2; Otherwise, No. Higher scores of Bell's staging criteria denote a worse outcome, where "1" denotes suspect, "2" definite and "3" advanced NEC. |
| Secondary | Number of Transfusions Per Infant | Birth, up to the earliest of: death, hospital discharge, or 36 weeks postmenstrual age (PMA) | This is measured as the number of protocol compliant transfusions, clinically justified non-protocol transfusions and unjustified non-protocol transfusions (violations) |
| Secondary | Weight-for-age: Z-score | at 36 weeks postmenstrual age or initial hospital discharge, whichever occurs first | This is measured as the weight-for-age Z-score at 36 weeks postmenstrual age or at initial hospital discharge, whichever occurs first. The Z-score is determined using Olsen percentile curves, and is derived from a normal distribution, where 0 designates average weight-for-age, and negative scores denote less than average weight-for-age. |
| Secondary | Length-for-age: Z-score | at 36 weeks postmenstrual age or initial hospital discharge, whichever occurs first | This is measured as the length-for-age Z-score at 36 weeks postmenstrual age or at initial hospital discharge, whichever occurs first. The Z-score is determined using Olsen percentile curves, and is derived from a normal distribution, where 0 designates average length-for-age, and negative scores denote less than average length-for-age. |
| Secondary | Head Circumference-for-age: Z-score | at 36 weeks postmenstrual age or initial hospital discharge, whichever occurs first | This is measured as the head circumference-for-age Z-score at 36 weeks postmenstrual age or at initial hospital discharge, whichever occurs first. The Z-score is determined using Olsen percentile curves, and is derived from a normal distribution, where 0 designates average head circumference-for-age, and negative scores denote less than average head circumference-for-age. |
| Secondary | Postmenstrual Age at Final Trachael Extubation | at final trachael extubation, assessed from birth up to the earliest of: death, hospital discharge, or 36 weeks postmenstrual age | This is measured as the average postmenstrual age (in weeks) at final tracheal extubation in infants who were intubated. |
| Secondary | Postmenstrual Age at Final Caffeine Dose in Infants Who Received Caffeine Treatment | at final caffeine dose, assessed from birth up to the earliest of: death, hospital discharge, or 36 weeks postmenstrual age | This is measured as the average postmenstrual age (in weeks) at final caffeine dose in infants who received caffeine treatment. |
| Secondary | Length of Stay | at initial hospital discharge or at death if it occurs earlier (a median of 97 days) | This is measured as the length of stay (in days) up to initial hospital discharge or death, whichever occurred first. |
| Secondary | Time to Full Enteral Feeding | at first full enteral feeding, assessed from birth up to initial hospital discharge or to death if it occurs earlier (a median of 97 days) | This is measured as the amount of days it took for full enteral feeding to occur. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01702805/registered