Trial · NCT01222247
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Neonatal Composite Outcome | 72 hours of life | Need for respiratory support: Continuous positive airway pressure (CPAP) or humidified high-flow nasal cannula (HHFNC) for greater than or equal to 2 hours or more in the first 72 hours, or fraction of inspired oxygen (FiO2) greater than or equal to 0.30 for 4 hours or more in the first 72 hours, or mechanical ventilation in the first 72 hours, or Extracorporeal membrane oxygenation (ECMO) Stillbirth, or neonatal death less than 72 hours of age |
| Secondary | Number of Neonates With Severe Respiratory Complication, | 72 hours of life | A severe respiratory complication was defined as any of the following occurrences within 72 hours after birth: CPAP or high-flow nasal cannula for at least 12 hours, supplemental oxygen with a fraction of inspired oxygen of 0.30 or more for at least 24 hours, mechanical ventilation, stillbirth or neonatal death, or the need for ECMO. Except for the duration of CPAP or high-flow nasal cannula and the duration of a fraction of inspired oxygen of 0.30 or more, the criteria for a severe respiratory complication overlap with those of the primary outcome. |
| Secondary | Neonates Needing Immediate Resuscitation After Birth | Within the first 30 minutes of birth | Need for resuscitation after birth: any intervention in the first 30 minutes other than blow-by oxygen |
| Secondary | Number of Neonates With Respiratory Distress Syndrome | Delivery | Respiratory distress defined as the presence of clinical signs of respiratory distress (tachypnea, retractions, flaring, grunting, or cyanosis) with an oxygen requirement and a chest x-ray that shows hypoaeration and reticulogranular infiltrates |
| Secondary | Number of Neonates With Transient Tachypnea of the Newborn | by 72 hours after delivery | TTN is defined as signs of respiratory distress, specifically tachypnea, that are resolved by 72 hours of age. TTN may be diagnosed in the absence of a chest X-ray or with a chest X-ray that is normal or shows signs of increased perihilar interstitial markings |
| Secondary | Number of Infants With Neonatal Apnea | 72 hours of life | Neonatal apnea with respiratory pauses of more than 20 seconds duration resulting in bradycardia or oxygen desaturation below baseline. |
| Secondary | Number of Infants withChronic Lung Disease / Bronchopulmonary Dysplasia (BPD) Requiring Supplemental Oxygen | 28 days of life | Infants requiring supplemental oxygen of more than 0.21 for the first 28 days of life |
| Secondary | Neonates With Pneumonia | by 72 hours of life | Neonatal pneumonia |
| Secondary | Number of Neonates Needing Surfactant Administration | Delivery | Administration of surfactant for neonatal respiratory treatment |
| Secondary | Neonatal Outcome Composite | 72 hours of life | Transient tachypnea of the newborn (TTN), respiratory distress syndrome (RDS), and apnea |
| Secondary | Number of Neonates With Pulmonary Air Leak | 72 hours post delivery | Neonatal pulmonary air leak syndrome |
| Secondary | Neonatal Death After 72 Hours of Delivery | 72 hours after delivery through hospital discharge up to 3 weeks | Neonatal death after 72 hours of life but before hospital discharge. |
| Secondary | Birth Weight | Delivery | Weight in grams at delivery |
| Secondary | Birth Weight Less Than 10th Percentile | Delivery | Neonates whose birth weight is less than the 10th percentile at delivery |
| Secondary | Gestational Age at Delivery | Delivery | Number of neonates delivered at ≤ 34 weeks 6 days, between 35 weeks 0 days and 35 weeks 6 days, between 36 weeks 0 days and 36 weeks 6 days, between 37 weeks 0 days and 38 weeks 6 days, or on or after 39 weeks 0 days |
| Secondary | Number of Neonates With Necrotizing Enterocolitic (NEC) | Delivery | Defined as modified Bell Stage 2 or 3. Stage 2: Clinical signs and symptoms with pneumatosis intestinalis on radiographs. Stage 3: Advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation. |
| Secondary | Number of Infants With Neonatal Sepsis | Delivery | Clinical suspicion of systemic infection with a positive blood, cerebral spinal fluid, or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evience of cardiovascular collapse or an X-ray confirming infection. |
| Secondary | Number of Neonates With Intraventricular Hemorrhage | Delivery | Grade 3 or 4 Intraventricular Hemorrhage |
| Secondary | Neonatal Morbidity Composite | Delivery | A composite endpoint of morbidities known to be affected by steroid administration will also be evaluated. Specifically, this composite will include RDS, intraventricular hemorrhage (IVH), and NEC |
| Secondary | Number of Neonates With Hypoglycemia | Delivery through hospital discharge up to 3 weeks | Glucose \< 40 mg per deciliter (2.2 mmol per liter) at any time |
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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