Trial · NCT06855108
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite outcome, defined by the occurrence of any of the following: | 18-22 months | All-cause infant mortality or moderate to severe neurodevelopmental impairment |
| Secondary | Secondary composite outcome, defined by the occurrence of any of the following: | 18-22 months | All-cause infant mortality or severe neurodevelopmental impairment |
| Secondary | All-cause neonatal mortality | 28 days after delivery | Death from any cause to 28 days after delivery |
| Secondary | All-cause infant mortality | 12 months | Death from any cause before first birthday |
| Secondary | All-cause mortality | 18 months | Death from any cause |
| Secondary | Time to all-cause mortality | 18-22 months | Timespan from randomization to death from any cause |
| Secondary | Severe neurodevelopmental impairment | 18-22 months | |
| Secondary | Moderate neurodevelopmental impairment | 18-22 months | |
| Secondary | Composite cognitive, language, and motor scores on the Bayley Scales of Infant and Toddler Development-Fourth Edition | 18-22 months | Cognitive Scale on the Bayley Scales of Infant and Toddler Development - Fourth Edition \- Scale ranges from 55-145 such that higher scores indicate a better cognitive outcome. Language Scale on the Bayley Scales of Infant and Toddler Development - Fourth Edition - Scale ranges from 45-155 such that higher scores indicate a better language outcome. Motor Scale on the Bayley Scales of Infant and Toddler Development - Fourth Edition \- Scale ranges from 45-155 such that higher scores indicate a better motor outcome. |
| Secondary | Hammersmith Infant Neurological Exam score | 6 months | Ranges from 0 to 78 where higher scores indicate a better neurological outcome. |
| Secondary | Global Scale for Early Development D-score and DAZ | 12 months | Global Scale for Early Development D-score: Ranges from 0 to 100 where higher scores indicate a higher level of overall development. Global Scale for Early Development DAZ: Ranges from -5 to 5 where higher scores indicate a higher level of overall development. |
| Secondary | Global Scale for Early Development Short Form D-score and DAZ | 18-22 months | Global Scale for Early Development D-score: Ranges from 0 to 100 where higher scores indicate a higher level of overall development. Global Scale for Early Development DAZ: Ranges from -5 to 5 where higher scores indicate a higher level of overall development. |
| Secondary | Acute kidney injury within the first postnatal week | Postnatal days 2-4 | Defined as an increase in serum creatinine of 0.3 mg/dL or more on 2 measurements |
| Secondary | Manual blood pressure (systolic and diastolic) | 18-22 months | Systolic and diastolic blood pressure taken using manual measurement |
| Secondary | Hypertension | 18-22 months | Based on the systolic blood pressure at the ≥95% for age related normative values |
| Secondary | Serum creatinine | 18-22 months | Measured using serum creatinine testing. |
| Secondary | Serious adverse events (SAEs) | Discharge or 7 days after administration of the last study drug (whichever occurs first) | An SAE form will be completed for any event meeting the following criteria: * Results in participant death; * Is life-threatening; * Requires hospitalization or prolongs existing hospitalization; * Results in persistent or significant disability or incapacity; * Any other serious or unexpected AE that the study investigator(s) feels should be reported. |
| Secondary | Adverse events of special interest (AESIs) | Discharge or 7 days after administration of the last study drug (whichever occurs first) | To include: * Clinically diagnosed seizures * Receipt of any antiepileptic drug * Seizures not controlled on one antiepileptic drug * Hypoglycemia (BG \<30 mg/dL) * Hyperglycemia (BG \>200 mg/dL) * Heart rate \[HR\] \>180 beats per minute \[bpm\] within 30 minutes of study drug administration * Necrotizing enterocolitis (NEC): as defined by feeding intolerance, bloody stool and abdominal distension |
| Secondary | Length/height and length/height-for-age z-score | Birth, 1 month, 6 months, 12 months, and 18-22 months | Length/height and length/height-for-age z-score |
| Secondary | Weight and weight-for-age z-score | Birth, 1 month, 6 months, 12 months, and 18-22 months | Weight and weight-for-age z-score |
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
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GET https://conductscience.org/api/trials/v1/NCT06855108/registered