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

Not Applicable

Completed

• Conditions: Asphyxia
• Interventions: Other: 100% oxygen; Other: Resuscitation

• 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.

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-02
• Study First Submitted: 2011-02-25
• Study First Submitted QC: 2011-02-25
• Study First Posted: 2011-02-28
• Study Completion: 2011-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-25
• Last Update Posted: 2014-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

• known chromosomal or congenital anomalies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
100% Oxygen	100% oxygen	Initiation of resuscitation with 100% Oxygen and achieve oxygen saturation in the preset limits 85-92%
Room air	Resuscitation	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%

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