NCT01305031

Resuscitation of Late-preterm Infants by Using Room Air or 100% Oxygen

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Nanjing Medical University · Academic / Other
• Sex: All
• Age: 34 Weeks – 37 Weeks
• Healthy volunteers: Not accepted

Summary

In this randomized control trial, the investigators hypothesize that late-preterm infants resuscitated with a "low oxygen delivery" strategy (initiation of resuscitation with room air) will result in a significant reduction in oxidant stress without any harmful clinical effects.

Detailed description

The delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Some studies have shown that resuscitation of term newborn infants with room air were safe and of great benefit. A static room air, however, may be inappropriate for resuscitation of preterm infants. The number of late-preterm infants has increased in recent years, which represent approximately 70% of all preterm infants. Our study will evaluate the safety and efficacy of using room air during resuscitation of late-preterm infants and whether this will avoid oxidative stress derived damage and improve outcomes.

Conditions

• Asphyxia

Interventions

Type	Name	Description
OTHER	Resuscitation	Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-92%
OTHER	100% oxygen	Use of 100% oxygen needed to achieve oxygen saturation in the preset limits 85-92%

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-02-01
• Completion: 2011-12-01
• First posted: 2011-02-28
• Last updated: 2014-10-28

Locations

1 site across 1 country: China