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

Primary Purpose

Asphyxia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Resuscitation
100% oxygen
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asphyxia focused on measuring Asphyxia, Resuscitation, Room Air

Eligibility Criteria

34 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

• known chromosomal or congenital anomalies

Sites / Locations

  • Nanjing Maternal and Child Care Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Room air

100% Oxygen

Arm 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%

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

Outcomes

Primary Outcome Measures

oxidative stress status
oxygen saturations

Secondary Outcome Measures

Days on oxygen
Days on conventional ventilation
Days on high frequency ventilation
Days on nasal canula
Pneumothorax
Oxygen requirement
Patent ductus arteriosus
Necrotizing Enterocolitis
Intracranial hemorrhage
Hypoxic ischemic encephalopathy
Retinopathy of prematurity
Death

Full Information

First Posted
February 25, 2011
Last Updated
October 25, 2014
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01305031
Brief Title
Resuscitation of Late-preterm Infants by Using Room Air or 100% Oxygen
Official Title
Resuscitation of Late-preterm Infants by Using Room Air or 100% Oxygen
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asphyxia
Keywords
Asphyxia, Resuscitation, Room Air

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Room air
Arm Type
Experimental
Arm 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%
Arm Title
100% Oxygen
Arm Type
Active Comparator
Arm Description
Initiation of resuscitation with 100% Oxygen and achieve oxygen saturation in the preset limits 85-92%
Intervention Type
Other
Intervention Name(s)
Resuscitation
Intervention Description
Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-92%
Intervention Type
Other
Intervention Name(s)
100% oxygen
Intervention Description
Use of 100% oxygen needed to achieve oxygen saturation in the preset limits 85-92%
Primary Outcome Measure Information:
Title
oxidative stress status
Time Frame
7 days
Title
oxygen saturations
Time Frame
10 min
Secondary Outcome Measure Information:
Title
Days on oxygen
Time Frame
28 days
Title
Days on conventional ventilation
Time Frame
28 days
Title
Days on high frequency ventilation
Time Frame
28 days
Title
Days on nasal canula
Time Frame
28 days
Title
Pneumothorax
Time Frame
28 days
Title
Oxygen requirement
Time Frame
At 36 weeks adjusted age
Title
Patent ductus arteriosus
Time Frame
28 days
Title
Necrotizing Enterocolitis
Time Frame
28 days
Title
Intracranial hemorrhage
Time Frame
28 days
Title
Hypoxic ischemic encephalopathy
Time Frame
28 days
Title
Retinopathy of prematurity
Time Frame
28 days
Title
Death
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
34 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: inborn infant gestation 34 weeks to 36 weeks 6 days Exclusion Criteria: • known chromosomal or congenital anomalies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuping Han, PhD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing Maternal and Child Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China

12. IPD Sharing Statement

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

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