NCT05657795 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Abdo M, Hanbal A, Asla MM, Ishqair A, Alfar M, Elnaiem W, Ragab KM, Nourelden AZ, Zaazouee MS
Automated versus manual oxygen control in preterm infants receiving respiratory support: a systematic review and meta-analysis. J Matern Fetal Neonatal Med. 2022 Dec;35(25):6069-6076. doi: 10.1080/14767058.2021.1904875. Epub 2021 Apr 8.
Lakshminrusimha S, Konduri GG, Steinhorn RH
Considerations in the management of hypoxemic respiratory failure and persistent pulmonary hypertension in term and late preterm neonates. J Perinatol. 2016 Jun;36 Suppl 2:S12-9. doi: 10.1038/jp.2016.44.
Ramadan G, Paul N, Morton M, Peacock JL, Greenough A
Outcome of ventilated infants born at term without major congenital abnormalities. Eur J Pediatr. 2012 Feb;171(2):331-6. doi: 10.1007/s00431-011-1549-8. Epub 2011 Aug 11.
Salverda HH, Cramer SJE, Witlox RSGM, Dargaville PA, Te Pas AB
Automated oxygen control in preterm infants, how does it work and what to expect: a narrative review. Arch Dis Child Fetal Neonatal Ed. 2021 Mar;106(2):215-221. doi: 10.1136/archdischild-2020-318918. Epub 2020 Jul 30.
Sturrock S, Ambulkar H, Williams EE, Sweeney S, Bednarczuk NF, Dassios T, Greenough A
A randomised crossover trial of closed loop automated oxygen control in preterm, ventilated infants. Acta Paediatr. 2021 Mar;110(3):833-837. doi: 10.1111/apa.15585. Epub 2020 Oct 6.
Williams LZJ, McNamara D, Alsweiler JM
Intermittent Hypoxemia in Infants Born Late Preterm: A Prospective Cohort Observational Study. J Pediatr. 2019 Jan;204:89-95.e1. doi: 10.1016/j.jpeds.2018.08.048. Epub 2018 Oct 1.

Does Closed-loop Automated Oxygen Control During Mechanical Ventilation Reduce the Duration of Supplementary Oxygen Treatment and the Amount of Time Spent in Hyperoxia? A Randomised Trial in Ventilated Infants Born at or Near Term

Details for clinical trial NCT05657795

Clinical trial NCT05657795 - References