Trial · NCT04430790
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Death or severe disability | 2 years corrected age | Disability will be defined as cognitive delay, cerebral palsy, severe hearing loss, or bilateral blindness. Cognitive delay will be defined as a Mental Development Index score of less than 85 on the Bayley Scales of Infant and Toddler Development, Bayley Score of Infant Development (BSID) III scores. Cerebral palsy will be diagnosed if the child had a non-progressive motor impairment characterized by abnormal muscle tone and decreased range or control of movements. The level of gross motor function will be determined with the use of the Gross Motor Function Classification System. Audiometry will be performed to determine the presence or absence of hearing loss. Blindness will be defined as a corrected visual acuity less than 20/200 |
| Secondary | Broncho pulmonary dysplasia | 36 weeks post menstrual age | Diagnosed according to the National Institute of Child Health and Human Development (NICHD) criteria |
| Secondary | Death | until 36 weeks post menstrual age and until hospital discharge | Death at 36 weeks post menstrual age and hospital mortality |
| Secondary | Admission period | through study completion and until discharge home, average 3 months | Length of stay at the intensive care, length of stay in hospital |
| Secondary | Endotracheal intubations | Day 3, 7, 14, and 21 after start of study medication | Incidence of endotracheal intubations |
| Secondary | Oxygenation days and complications | During first hospital admittance and through study completion, average of 3 months | Number of days on invasive ventilation, number of days on ventilatory support (non-invasive ventilation, CPAP, humidified high flow, low flow), number of days with supplemental oxygen, respiratory complications (airleak, pneumonia, etc), use of (rescue) corticosteroids for respiratory reasons. |
| Secondary | Gastro-intestinal outcome measures | During first hospital admittance and until 36 weeks post menstrual age | solitary intestinal perforation, necrotizing enterocolitis \> stage 2 according to Bell, feeding problems with need for parental feeding (days with parental feeding after inclusion), body weight (gain, length), head circumference |
| Secondary | Neurological outcome measures | During first hospital admittance or at term equivalent age (37-42 weeks postmenstrual age), average 3 months | Intraventricular hemorhage(IVH) (all grades, grade III-IV, venous infarction), clinical seizures, periventricular leucomalacia (PVL) \> gr 1) |
| Secondary | Complications during neonatal period | During first hospital admittance or at term equivalent age (37-42 weeks postmenstrual age), average 3 months | Incidence of late onset sepsis (culture proven or clinical suspected) and meningitis after inclusion, need for inotropes/circulatory support |
| Secondary | Retinopathy of prematurity | During first hospital admittance or at term equivalent age (37-42 weeks postmenstrual age), average 3 months | Grade of retinopathy (including plus disease and need for therapy) |
| Secondary | Hearing | At term equivalent age, 37-42 weeks postmenstrual age, average 3 months | Hearing test |
| Secondary | Additional long term outcomes | 2 years corrected age | Readmissions since first discharge home, weight/length/head circumference, behavioral problems (Child Behavior Checklist) |
| Secondary | Parent reported outcome | 2 years corrected age | Parent reported outcome with the PARCA-R (Parent Report of Children's Abilities-Revised) questionnaire (expected mean standardised scores 100 (SD 15), higher score is better outcome) |
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/NCT04430790/registered