The Effect of Oxygen Exposure During Newborn Resuscitation on Lung Injury

Prematurity Clinical Trial

Official title:

Oxygen Exposure During Newborn Resuscitation and Pulmonary Oxidative Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355875
• Other study ID #: RT754957
• Status: Completed
• Phase: N/A
• First received: July 22, 2006
• Last updated: November 6, 2006
• Start date: July 2005
• Est. completion date: October 2006

Study information

• Verified date: November 2006
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 23 Weeks to 32 Weeks

Eligibility

Inclusion Criteria:

• <=32 weeks gestation

• inborn

• require intubation

Exclusion Criteria:

• lethal anomalies

• cyanotic congenital heart disease

• known hemoglobinopathy

• risk factors for persistent pulmonary hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lung Injury
• Oxidative Pulmonary Injury
• Prematurity

Intervention

Procedure:
• titration of oxygen during resuscitation

Locations

Country	Name	City	State
Canada	Canada	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Equipment loan from Masimo Corp.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	protein carbonyl concentration in the tracheal aspirate on day 1
Secondary	protein carbonyl concentration in the tracheal aspirate on day 3
Secondary	protein carbonyl concentration in the tracheal aspirate on day 7
Secondary	protein carbonyl concentration in the tracheal aspirate on day 14
Secondary	protein carbonyl concentration in the tracheal aspirate on day 21
Secondary	protein carbonyl concentration in the tracheal aspirate on day 28