Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
Summary
This study hopes to determine whether nitric oxide along with oxygen during the first 20 minutes of life in infants needing help with breathing will reduce the percentage and total exposure to oxygen during that time frame. Although the use of oxygen in management of breathing is an important part of supporting baby immediately after delivery, there is more evidence that too much exposure to oxygen may lead to potential problems for your baby later. Oxygen exposure can be harmful to premature babies developing lungs.
Timeline
- Start
- 2011-04
- Primary completion
- 2017-01
- Completion
- 2017-05-01
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo 20ppm vs iNO 20 Ppm; p = 0.0012; Mean Difference (Final Values) 9; t-test, 2 sided NCT01220687 ↗
registry analysis (superiority test); Placebo 20ppm vs iNO 20 Ppm; p <0.0001; Rate Ratio 1.91 (95% CI 1.68 to 2.18); Poisson NCT01220687 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | iNO | Unknown | 20 ppm | Inhaled |