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OpenTrials
Completed

NCT Number: NCT00355875

The Effect of Oxygen Exposure During Newborn Resuscitation on Lung Injury

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.

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Oxidative Pulmonary Injury Pregnancy Complications Premature Birth Urogenital Diseases

Age range

23 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canada

Calgary, Alberta, T2N 2T9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • <=32 weeks gestation
  • inborn
  • require intubation

Exclusion criteria

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

Treatment and study plan

titration of oxygen during resuscitation

Procedure

Primary outcomes

  1. protein carbonyl concentration in the tracheal aspirate on day 1

Secondary outcomes

  1. protein carbonyl concentration in the tracheal aspirate on day 3

  2. protein carbonyl concentration in the tracheal aspirate on day 7

  3. protein carbonyl concentration in the tracheal aspirate on day 14

  4. protein carbonyl concentration in the tracheal aspirate on day 21

  5. protein carbonyl concentration in the tracheal aspirate on day 28

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Equipment loan from Masimo Corp.

Registry information

Official study title

Oxygen Exposure During Newborn Resuscitation and Pulmonary Oxidative Stress

Important dates

Study start
2005
Study completion
2006
First posted
Jul 25, 2006
Registry last updated
Nov 7, 2006

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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