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Completed

NCT Number: NCT01305031

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

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.

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Key information

Conditions

Asphyxia Death Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

34 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Maternal and Child Care Hospital

Nanjing, Jiangsu, 210004, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • known chromosomal or congenital anomalies

Treatment and study plan

Resuscitation

Other

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

100% Oxygen

Other

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

Primary outcomes

  1. oxidative stress status

    Time frame: 7 days

  2. oxygen saturations

    Time frame: 10 min

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 28, 2011
Registry last updated
Oct 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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