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

Asphyxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305031
• Other study ID #: NMU-FY2011-225, YKK10038
• Status: Completed
• Phase: N/A
• First received: February 25, 2011
• Last updated: October 25, 2014
• Start date: February 2011
• Est. completion date: December 2011

Study information

• Verified date: October 2014
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 34 Weeks to 37 Weeks

Eligibility

Inclusion Criteria:

• inborn infant

• gestation 34 weeks to 36 weeks 6 days

Exclusion Criteria:

• known chromosomal or congenital anomalies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asphyxia

Intervention

Other:
• Resuscitation
Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-92%
• 100% oxygen
Use of 100% oxygen needed to achieve oxygen saturation in the preset limits 85-92%

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxidative stress status		7 days	Yes
Primary	oxygen saturations		10 min	Yes
Secondary	Days on oxygen		28 days	Yes
Secondary	Days on conventional ventilation		28 days	Yes
Secondary	Days on high frequency ventilation		28 days	Yes
Secondary	Days on nasal canula		28 days	Yes
Secondary	Pneumothorax		28 days	Yes
Secondary	Oxygen requirement		At 36 weeks adjusted age	Yes
Secondary	Patent ductus arteriosus		28 days	Yes
Secondary	Necrotizing Enterocolitis		28 days	Yes
Secondary	Intracranial hemorrhage		28 days	Yes
Secondary	Hypoxic ischemic encephalopathy		28 days	Yes
Secondary	Retinopathy of prematurity		28 days	Yes
Secondary	Death		28 days	Yes