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The Effect of Oxygen Exposure During Newborn Resuscitation on Lung Injury

NCT ID: NCT00355875

Last Updated: 2006-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-10-31

Brief Summary

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Hypothesis: In this feasibility study, hyperoxemia, as approximated by transcutaneous hemoglobin saturation with oxygen (Sp02), at the time of birth will cause sustained pulmonary oxidative stress as demonstrated by elevation of pulmonary protein carbonyl. Furthermore, this oxidative stress will be directly proportional to the imposed oxygen-burden during resuscitation at the time of birth.

This study will give us information regarding the magnitude of protein carbonyl elevation in the preterm infant. With these results we will be able to 1. establish the technique for the running or protein carbonyl assays and 2. calculate an appropriate sample size for a future randomized control trial.

Detailed Description

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Immediately prior to birth, preterm infants (\<= 32 weeks gestation) will be randomized to one of three groups: 1. Low Oxygen Burden (LOB) - initiation of resuscitation with 21% 02, II. Moderate Oxygen Burden (MOB) - initiation of resuscitation with 100% 02 and III. High Oxygen Burden (HOB) - 100% 02 used for the entire resuscitation. A pulse oximetry monitor will be connected to a probe on the infant's hand to measure the transcutaneous hemoglobin saturation with oxygen (Sp02). Adjustments to the inspired oxygen concentration will be made every 15 seconds for infants in the LOB and MOB groups to achieve a target Sp02 range of 85-92%. Resuscitation will otherwise proceed as per standard of care. The intervention will end upon arrival in the neonatal intensive care unit.

Conditions

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Prematurity Oxidative Pulmonary Injury

Keywords

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newborn preterm resuscitation oxidative injury protein carbonyl

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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titration of oxygen during resuscitation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* \<=32 weeks gestation
* inborn
* require intubation

Exclusion Criteria

* lethal anomalies
* cyanotic congenital heart disease
* known hemoglobinopathy
* risk factors for persistent pulmonary hypertension
Minimum Eligible Age

23 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Equipment loan from Masimo Corp.

UNKNOWN

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Principal Investigators

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Yacov Rabi, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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Canada

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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RT754957

Identifier Type: -

Identifier Source: org_study_id