NCT00355875

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

November 7, 2006

Status Verified

November 1, 2006

First QC Date

July 22, 2006

Last Update Submit

November 6, 2006

Conditions

PrematurityOxidative Pulmonary Injury

Keywords

newbornpretermresuscitationoxidative injuryprotein carbonyl

Outcome Measures

Primary Outcomes (1)

  • protein carbonyl concentration in the tracheal aspirate on day 1

Secondary Outcomes (5)

  • protein carbonyl concentration in the tracheal aspirate on day 3

  • protein carbonyl concentration in the tracheal aspirate on day 7

  • protein carbonyl concentration in the tracheal aspirate on day 14

  • protein carbonyl concentration in the tracheal aspirate on day 21

  • protein carbonyl concentration in the tracheal aspirate on day 28

Interventions

titration of oxygen during resuscitationPROCEDURE

Eligibility Criteria

Age23 Weeks - 32 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • lethal anomalies
  • cyanotic congenital heart disease
  • known hemoglobinopathy
  • risk factors for persistent pulmonary hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canada

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Yacov Rabi, MD, FRCPC

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 22, 2006

First Posted

July 25, 2006

Study Start

July 1, 2005

Study Completion

October 1, 2006

Last Updated

November 7, 2006

Record last verified: 2006-11

Locations

CA(1)