Resuscitation of Late-preterm Infants by Using Room Air or 100% Oxygen
- Conditions
- Asphyxia
- Registration Number
- NCT01305031
- Lead Sponsor
- Nanjing Medical University
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- inborn infant
- gestation 34 weeks to 36 weeks 6 days
• known chromosomal or congenital anomalies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method oxidative stress status 7 days oxygen saturations 10 min
- Secondary Outcome Measures
Name Time Method Necrotizing Enterocolitis 28 days Retinopathy of prematurity 28 days Days on oxygen 28 days Intracranial hemorrhage 28 days Days on conventional ventilation 28 days Days on nasal canula 28 days Pneumothorax 28 days Days on high frequency ventilation 28 days Oxygen requirement At 36 weeks adjusted age Hypoxic ischemic encephalopathy 28 days Patent ductus arteriosus 28 days Death 28 days
Trial Locations
- Locations (1)
Nanjing Maternal and Child Care Hospital
🇨🇳Nanjing, Jiangsu, China
Nanjing Maternal and Child Care Hospital🇨🇳Nanjing, Jiangsu, China