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

Sponsor

Nanjing Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT01305031

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asphyxia	Other: Resuscitation Other: 100% oxygen	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

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%

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%

Outcome Measures

Primary Outcome Measures

oxidative stress status [7 days]
oxygen saturations [10 min]

Secondary Outcome Measures

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]
Death [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

34 Weeks to 37 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

inborn infant
gestation 34 weeks to 36 weeks 6 days

Exclusion Criteria:

• known chromosomal or congenital anomalies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanjing Maternal and Child Care Hospital	Nanjing	Jiangsu	China	210004

Sponsors and Collaborators

Nanjing Medical University

Investigators

Study Director: Shuping Han, PhD, Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhangbin Yu, Director, Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT01305031

Other Study ID Numbers:

NMU-FY2011-225, YKK10038

First Posted:

Feb 28, 2011

Last Update Posted:

Oct 28, 2014

Last Verified:

Oct 1, 2014

Keywords provided by Zhangbin Yu, Director, Nanjing Medical University

Asphyxia

Resuscitation

Room Air

Additional relevant MeSH terms:

Asphyxia

Study Results

No Results Posted as of Oct 28, 2014