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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Room air | Experimental | Initiation of resuscitation with 21% Oxygen, adjustments to the inspired oxygen concentration (increased 10%) will be made every 60 seconds for infants to achieve a target SpO2 range of 85-92% |
|
| 100% Oxygen | Active Comparator | Initiation of resuscitation with 100% Oxygen and achieve oxygen saturation in the preset limits 85-92% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resuscitation | Other | Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-92% |
|
| Measure | Description | Time Frame |
|---|---|---|
| oxidative stress status | 7 days | |
| oxygen saturations | 10 min |
| Measure | Description | Time Frame |
|---|---|---|
| Days on oxygen | 28 days | |
| Days on conventional ventilation | 28 days | |
| Days on high frequency ventilation |
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Inclusion Criteria:
Exclusion Criteria:
• known chromosomal or congenital anomalies
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| Name | Affiliation | Role |
|---|---|---|
| Shuping Han, PhD | Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Maternal and Child Care Hospital | Nanjing | Jiangsu | 210004 | China |
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| ID | Term |
|---|---|
| D001237 | Asphyxia |
| ID | Term |
|---|---|
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D012151 | Resuscitation |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D004638 | Emergency Treatment |
| D013812 | Therapeutics |
| D018011 | Chalcogens |
| D004602 | Elements |
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| 100% oxygen | Other | Use of 100% oxygen needed to achieve oxygen saturation in the preset limits 85-92% |
|
| 28 days |
| Days on nasal canula | 28 days |
| Pneumothorax | 28 days |
| Oxygen requirement | At 36 weeks adjusted age |
| Patent ductus arteriosus | 28 days |
| Necrotizing Enterocolitis | 28 days |
| Intracranial hemorrhage | 28 days |
| Hypoxic ischemic encephalopathy | 28 days |
| Retinopathy of prematurity | 28 days |
| Death | 28 days |
| D007287 |
| Inorganic Chemicals |
| D005740 | Gases |