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

Nanjing Medical University

Status: Completed

Conditions: Asphyxia

Treatments: Other: Resuscitation; Other: 100% oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT01305031

NMU-FY2011-225, YKK10038

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 34 to 37 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• inborn infant
• gestation 34 weeks to 36 weeks 6 days

Exclusion criteria

• known chromosomal or congenital anomalies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Room air

Experimental group

Description:

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%

Treatment:

Other: Resuscitation

100% Oxygen

Active Comparator group

Description:

Initiation of resuscitation with 100% Oxygen and achieve oxygen saturation in the preset limits 85-92%

Treatment:

Other: 100% oxygen