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

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.

Study Overview

• Status: Completed
• Conditions: Asphyxia
• Intervention / Treatment: Other: Resuscitation; Other: 100% oxygen

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210004
      • Nanjing Maternal and Child Care Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• known chromosomal or congenital anomalies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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%	Other: Resuscitation; Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-92%
Active Comparator: 100% Oxygen; Initiation of resuscitation with 100% Oxygen and achieve oxygen saturation in the preset limits 85-92%	Other: 100% oxygen; Use of 100% oxygen needed to achieve oxygen saturation in the preset limits 85-92%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
oxidative stress status	7 days
oxygen saturations	10 min

Secondary Outcome Measures

Outcome Measure	Time Frame
Death	28 days
Days on oxygen	28 days
Days on conventional ventilation	28 days
Days on high frequency ventilation	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

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Investigators: Study Director: Shuping Han, PhD, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: February 25, 2011
• First Submitted That Met QC Criteria: February 25, 2011
• First Posted (Estimate): February 28, 2011

Study Record Updates

• Last Update Posted (Estimate): October 28, 2014
• Last Update Submitted That Met QC Criteria: October 25, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Asphyxia; Resuscitation; Room Air
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Death; Asphyxia
• Other Study ID Numbers: NMU-FY2011-225, YKK10038