Trial · NCT05395195
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of babies who die or survive with moderate or severe disability | 18 to 22 months | Death or moderate or severe disability in survivors |
| Secondary | Number of babies who die | Upto 22 months | Mortality from all causes |
| Secondary | Number of babies who survive without neurodisability | 18 to 22 months | Survival with Bayley composite scale scores \>84 in all domains, no cerebral palsy, no seizure disorder, hearing or visual defect |
| Secondary | Number of babies with cerebral palsy | 18 to 22 months | Cerebral palsy with a Gross Motor Function Classification Score \>1 |
| Secondary | Number of babies with microcephaly | 18 to 22 months | Head circumference more than 2 standard deviations below the mean |
| Secondary | Number of babies with gastric bleeds | During neonatal hospitalisation (Expected average of 2 weeks) | Fresh blood \> 5 ml from nasogastric tube |
| Secondary | Number of babies with persistent pulmonary hypertension | During neonatal hospitalisation (Expected average of 2 weeks) | Severe hypoxemia disproportionate to the severity of lung disease with a significant pre-and post ductal saturation difference on pulse oximetry |
| Secondary | Number of babies with coagulopathy | During neonatal hospitalisation (Expected average of 2 weeks) | Prolonged blood coagulation requiring blood products |
| Secondary | Number of babies with intracranial haemorrhage | During neonatal hospitalisation (Expected average of 2 weeks) | Major parenchymal or intraventricular bleed on cranial ultrasound or magnetic resonance imaging. |
| Secondary | Number of babies with culture-proven sepsis | During neonatal hospitalisation (Expected average of 2 weeks) | Isolation of a pathogenic organism from blood or cerebrospinal fluid along with clinical evidence of sepsis or elevation of C-reactive protein |
| Secondary | Number of babies with severe thrombocytopenia | During neonatal hospitalisation (Expected average of 2 weeks) | Platelet count of less than 25 000 per μL or less than 50 000 per μL with active bleeding |
| Secondary | Number of babies with abnormal neurological examination at discharge | During neonatal hospitalisation (Expected average of 2 weeks) | Structured neurological examination as per the NICHD NRN trial (Shankaran et al NEJM 2005) discharge exam criteria |
| Other | Basal ganglia/thalami magnetic resonance (MR) Lactate/NAA peak area ratio | 10 to 14 days after birth | Lactate/NAA peak area metabolic rations in the deep brain nuclei on proton MR spectroscopy |
| Other | Basal ganglia/thalami magnetic resonance (MR) NAA/Creatine peak area ratio | 10 to 14 days after birth | NAA/Creatine peak area metabolic rations in the deep brain nuclei on proton MR spectroscopy |
| Other | White matter magnetic resonance (MR) NAA/Creatine peak area ratio | 10 to 14 days after birth | NAA/Creatine peak area metabolic rations in the White matter on proton MR spectroscopy |
| Other | White matter magnetic resonance (MR) Lactate/NAA peak area ratio | 10 to 14 days after birth | Lactate/NAA peak area metabolic rations in the White matter on proton MR spectroscopy |
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.
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GET https://conductscience.org/api/trials/v1/NCT05395195/registered