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

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ClinicalTrials.gov Identifier: NCT01305031
Recruitment Status : Completed
First Posted : February 28, 2011
Last Update Posted : October 28, 2014
Information provided by (Responsible Party):

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
Asphyxia 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 Design

Study Type : Interventional  (Clinical Trial)
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 : February 2011
Primary Completion Date : February 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

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%

Outcome Measures

Primary Outcome Measures :
  1. oxidative stress status [ Time Frame: 7 days ]
  2. oxygen saturations [ Time Frame: 10 min ]

Secondary Outcome Measures :
  1. Days on oxygen [ Time Frame: 28 days ]
  2. Days on conventional ventilation [ Time Frame: 28 days ]
  3. Days on high frequency ventilation [ Time Frame: 28 days ]
  4. Days on nasal canula [ Time Frame: 28 days ]
  5. Pneumothorax [ Time Frame: 28 days ]
  6. Oxygen requirement [ Time Frame: At 36 weeks adjusted age ]
  7. Patent ductus arteriosus [ Time Frame: 28 days ]
  8. Necrotizing Enterocolitis [ Time Frame: 28 days ]
  9. Intracranial hemorrhage [ Time Frame: 28 days ]
  10. Hypoxic ischemic encephalopathy [ Time Frame: 28 days ]
  11. Retinopathy of prematurity [ Time Frame: 28 days ]
  12. Death [ Time Frame: 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   34 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

• known chromosomal or congenital anomalies

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305031

China, Jiangsu
Nanjing Maternal and Child Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Study Director: Shuping Han, PhD Nanjing Medical University
More Information

Responsible Party: Zhangbin Yu, Director, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01305031     History of Changes
Other Study ID Numbers: NMU-FY2011-225, YKK10038
First Posted: February 28, 2011    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014

Keywords provided by Zhangbin Yu, Nanjing Medical University:
Room Air

Additional relevant MeSH terms:
Pathologic Processes
Wounds and Injuries