Trial · NCT02772081
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety: Study Treatment Administration: Number of Participants Who Received 1, 2, or 3 Doses of Treatment | First 72 hours of life. | Extent of exposure to study treatment is summarized by treatment group. Number of participants who received 1, 2, or 3 doses of treatment. All neonates received the first administration of Curosurf® 200 mg/kg. In case of lack of efficacy or clinical deterioration, a second dose of Curosurf® 100 mg/kg was administered using the same technique as the first dose. Neonates could receive a third Curosurf® 100 mg/kg dose if needed, administered using a standard technique. Results are presented as the number of neonates who received 1, 2, or 3 doses of Curosurf®, administered. |
| Primary | Safety: Study Treatment Administration: Number of Participants for Whom the First Attempt Failed to Insert the Catheter/Endotracheal Tube | At first surfactant administration, up to Day 1. | Number of participants for whom the first attempt failed to insert the catheter/endotracheal tube and the percentage of neonates with first failed attempt, is presented by treatment group. |
| Primary | Safety: Study Treatment Administration: Number of Maneuvers Discontinued Due to Neonate's Severe Destabilization | At first surfactant administration, up to Day 1 or at second administration, up to 2 days. | Number of manoeuvres (attempts) discontinued, due to neonate's severe destabilization is presented by treatment group. |
| Primary | Safety: Study Treatment Administration: Number of Attempts to First Successful Insertion | At first surfactant administration, up to Day 1 or at second administration, up to 2 days. | Number of attempts required to achieve first successful insertion is presented by treatment group. |
| Primary | Safety: Study Treatment Administration: Number of Device Misallocation for LISA Administration Group (Esophageal Insertion) | At first surfactant administration, up to Day 1 or at second administration, up to 2 days. | Number of device misallocation for LISA administration group (esophageal insertion). Data was not collected from participants in the "Curosurf Endotracheal Tube" -- the control arm of the study, because it is not applicable. |
| Primary | Safety: Study Treatment Administration: Duration of Surfactant Administration | At first surfactant administration, up to Day 1 or at second administration, up to 2 days. | Duration of surfactant administration is presented by treatment group. |
| Primary | Safety: Study Treatment Administration: Duration of the Whole Procedure | At first surfactant administration, up to Day 1 or at second administration, up to 2 days. | Duration of the whole procedure (starting from the insertion of laryngoscope up to the removal of the catheter/ETT), is presented by treatment group. |
| Secondary | Efficacy: Duration of Oxygen Alone Supplementation and Any Non-Invasive Ventilation (NIV) | First 72 hours of life, Up to 28 days Post-Natal Age (PNA), Up to 36 weeks Post-Menstrual Age (PMA). | The duration of oxygen alone supplementation and any non-invasive ventilation (NIV) during the study are presented by treatment group. PMA=Post-Menstrual Age PNA=Post-Natal Age |
| Secondary | Efficacy: Neonates Needing Additional 2 or 3 Doses of Surfactant | First 72 hours of life. | A summary of the percentage of neonates requiring at least one additional dose of surfactant, and respective statistical analysis, is presented by treatment group i.e. 2 or 3 doses of surfactant . |
| Secondary | Efficacy: Neonates Needing Additional Surfactant Doses | First 72 hours of life. | A summary of the percentage of neonates requiring at least one additional dose of surfactant, and respective statistical analysis, is presented by treatment group. |
| Secondary | Efficacy: Preductal Oxygen Saturation/Fraction of Inspired Oxygen (SpO2/FiO2) Ratio | Pre-procedure, at time 0 (T0, end of surfactant instillation) and post treatment after T0 at 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72, and 120 hours, on Day 28 PNA, 36 weeks PMA. | The mean SpO2/FiO2 ratio values at timepoints up to and including 120 hours post-treatment, and respective statistical analyses, are summarized by treatment group. |
| Secondary | Efficacy: Fraction of Inspired Oxygen (FiO2) | Pre-procedure, at time 0 (T0, end of surfactant instillation) and post treatment after T0 at 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72, and 120 hours, on Day 28 PNA, 36 weeks PMA. | The FiO2 values at timepoints up to and including 120 hours post-treatment and the changes from pre-procedure to each of those timepoints are presented by treatment group. The fraction of inspired oxygen (FiO2) is the concentration of oxygen in the gas mixture. |
| Secondary | Efficacy: Preductal Oxygen Saturation (SpO2) | Pre-procedure, at time 0 (T0, end of surfactant instillation) and post treatment after T0 at 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72, and 120 hours, on Day 28 PNA, 36 weeks PMA. | The mean SpO2 values at timepoints up to and including 120 hours post-treatment are summarized by treatment group. Oxygen saturation (SpO2) is a measurement of how much oxygen the blood is carrying as a percentage of the maximum it could carry. |
| Secondary | Efficacy: Percentage of Neonates Needing Any Intubation Procedure, Outside the Initial Surfactant Administration Period | First 72 hours of life, up to 28 days post-natal age (PNA), Up to 36 weeks Post-menstrual age (PMA) | The percentage of neonates needing any intubation procedure, outside the initial surfactant administration period (i.e., excluding endotracheal intubation\[s\] that were required for surfactant administration in the Conventional administration arm), in the first 72 hours of life, in the first 28 days post-natal age (PNA), and within 36 weeks Post-menstrual age (PMA), and respective statistical analyses, are presented. |
| Secondary | Efficacy: Median Duration of Invasive Mechanical Ventilation During the Study | Up to 28 days PNA, Up to 36 weeks PMA | The duration of invasive ventilation (MV) in the first 28 days PNA, and within 36 weeks PMA, are presented by treatment group. Participants who actually received invasive ventilation are reported in the table below. |
| Secondary | Efficacy: Duration of Invasive Mechanical Ventilation During the Study | First 72 hours of life | The duration of invasive ventilation (MV) in the first 72 hours of life and respective statistical analyses, are presented by treatment group. |
| Secondary | Efficacy: Percentage of Neonates Needing Invasive Mechanical Ventilation (MV) During the Study | First 72 hours of life, Up to 28 days Post-Natal Age (PNA), Up to 36 weeks PMA | The percentage of neonates needing invasive mechanical ventilation (MV) in the first 72 hours of life, in the first 28 days post-natal age (PNA), and within 36 weeks Post-Menstrual Age (PMA), and respective statistical analyses, are presented by treatment group. |
| Secondary | Efficacy: Blood Gas Analysis Parameters -- pH | First 72 hours of life (1h, 6h, 24h, 48h, 72h) | The blood gas analysis for blood pH at all timepoints and the changes from pre-procedure to each timepoint are presented. Results for pH values are based on a scale of 0 to 14. A pH value of 7 is neutral, pH less than 7 is acidic, and pH greater than 7 is basic. |
| Secondary | Efficacy: Blood Gas Analysis Parameters -- Partial Pressure of Carbon Dioxide (pCO2) | First 72 hours of life (1h, 6h, 24h, 48h, 72h) | The blood gas analysis partial pressure of carbon dioxide (pCO2) at all timepoints and the changes from pre-procedure to each timepoint are presented. |
| Secondary | Efficacy: Blood Gas Analysis Parameters -- Partial Pressure of Oxygen (pO2) | First 72 hours of life (1h, 6h, 24h, 48h, 72h) | The blood gas analysis partial pressure of oxygen (pO2) at all timepoints and the changes from pre-procedure to each timepoint are presented. |
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.
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