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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Nanjing Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01305031
First received: February 25, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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 Intervention
Asphyxia
Other: Resuscitation
Other: 100% oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Resuscitation of Late-preterm Infants by Using Room Air or 100% Oxygen

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • oxidative stress status [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • oxygen saturations [ Time Frame: 10 min ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Days on oxygen [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Days on conventional ventilation [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Days on high frequency ventilation [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Days on nasal canula [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Pneumothorax [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Oxygen requirement [ Time Frame: At 36 weeks adjusted age ] [ Designated as safety issue: Yes ]
  • Patent ductus arteriosus [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Necrotizing Enterocolitis [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Intracranial hemorrhage [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Hypoxic ischemic encephalopathy [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Retinopathy of prematurity [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: February 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

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.

  Eligibility

Ages Eligible for Study:   34 Weeks to 37 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• known chromosomal or congenital anomalies

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305031

Locations
China, Jiangsu
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
  More Information

No publications provided

Responsible Party: Xirong Guo, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01305031     History of Changes
Other Study ID Numbers: NMU-FY2011-225, YKK10038
Study First Received: February 25, 2011
Last Updated: February 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Nanjing Medical University:
Asphyxia
Resuscitation
Room Air

Additional relevant MeSH terms:
Asphyxia
Death
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on April 14, 2014