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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01305031

Enrollment

Registered

2011-02-28

Start date

2011-02-28

Completion date

2011-12-31

Last updated

2014-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asphyxia

Keywords

Asphyxia, Resuscitation, Room Air

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.

Interventions

OTHERResuscitation

Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-92%

OTHER100% oxygen

Use of 100% oxygen needed to achieve oxygen saturation in the preset limits 85-92%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

34 Weeks to 37 Weeks

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

• known chromosomal or congenital anomalies

Design outcomes

Primary

Measure	Time frame
oxidative stress status	7 days
oxygen saturations	10 min

Secondary

Measure	Time frame
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
Days on oxygen	28 days
Intracranial hemorrhage	28 days
Hypoxic ischemic encephalopathy	28 days
Retinopathy of prematurity	28 days
Death	28 days
Necrotizing Enterocolitis	28 days
Days on conventional ventilation	28 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026