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

NCT ID: NCT01305031

Last Updated: 2014-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-12-31

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.

Conditions

Asphyxia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Room air

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%

Group Type: EXPERIMENTAL

Resuscitation

Intervention Type: OTHER

Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-92%

100% Oxygen

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

Group Type: ACTIVE_COMPARATOR

100% oxygen

Intervention Type: OTHER

Use of 100% oxygen needed to achieve oxygen saturation in the preset limits 85-92%

Interventions

Resuscitation

Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-92%

Intervention Type: OTHER

100% oxygen

Use of 100% oxygen needed to achieve oxygen saturation in the preset limits 85-92%

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• known chromosomal or congenital anomalies

• Minimum Eligible Age: 34 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhangbin Yu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shuping Han, PhD

Role: STUDY_DIRECTOR

Nanjing Medical University

Locations

Nanjing Maternal and Child Care Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

NMU-FY2011-225, YKK10038

Identifier Type: -

Identifier Source: org_study_id