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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Nanjing Medical University

Current Primary Outcome:

  • oxidative stress status [ Time Frame: 7 days ]
  • oxygen saturations [ Time Frame: 10 min ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Days on oxygen [ Time Frame: 28 days ]
  • Days on conventional ventilation [ Time Frame: 28 days ]
  • Days on high frequency ventilation [ Time Frame: 28 days ]
  • Days on nasal canula [ Time Frame: 28 days ]
  • Pneumothorax [ Time Frame: 28 days ]
  • Oxygen requirement [ Time Frame: At 36 weeks adjusted age ]
  • Patent ductus arteriosus [ Time Frame: 28 days ]
  • Necrotizing Enterocolitis [ Time Frame: 28 days ]
  • Intracranial hemorrhage [ Time Frame: 28 days ]
  • Hypoxic ischemic encephalopathy [ Time Frame: 28 days ]
  • Retinopathy of prematurity [ Time Frame: 28 days ]
  • Death [ Time Frame: 28 days ]


Original Secondary Outcome: Same as current

Information By: Nanjing Medical University

Dates:
Date Received: February 25, 2011
Date Started: February 2011
Date Completion:
Last Updated: October 25, 2014
Last Verified: October 2014