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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-92%
Use of 100% oxygen needed to achieve oxygen saturation in the preset limits 85-92%
Nanjing Maternal and Child Care Hospital
Nanjing, Jiangsu, China
oxidative stress status
Time frame: 7 days
oxygen saturations
Time frame: 10 min
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
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Death
Time frame: 28 days