Clinical Trial: Oxygen Toxicity in the Resuscitation in Extremely Premature Infants
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Achievement of a Targeted Saturation in Extremely Low Gestational Age Neonates Resuscitated With Low or High Oxygen Concentration: A Prospective Randomized Trial
Brief Summary: The investigators hypothesize that using low oxygen concentrations during resuscitation of extremely premature infants will avoid oxidative stress derived damage and improve outcome.
Detailed Summary:
This is a prospective randomized trial enrolling premature infants of less than 28 weeks gestation. Patients are randomly assigned to become resuscitation with an initial oxygen inspiratory fraction (FiO2) of 30% or 90%. Main objective is to reach a target saturation of 85% at 15 min of life.
Immediately after birth pre-and-postductal pulse oximeters are set and oxygen saturation (SpO2) continuously monitored and registered as long as the patient requires oxygen supplementation. FiO2 is stepwise adjusted (increased or decreased 10%) every 90 sec according to heart rate, SpO2 and responsiveness.
Blood samples are drawn from umbilical cord and at day 1, 2 and 7 from peripheral vein to determine oxidative stress markers (GSH, GSSG), angiogenic factors (VEGF, VEGF receptors, Angiopoietin), pro-inflammatory markers (IL8, TNF alfa) and pro-apoptotic markers (Fas Ligand; Cytochrome C).
Urine is collected every day during the first week of life to determine oxidative stress markers (8-oxo-dG; O-tyrosine; F2 isoprostanes; Isofurans).
Babies are followed in the NICU and clinical condition recorded. Serial examinations for ROP and Auditory evoked potentials will be performed. Neurodevelopmental outcome is evaluated at 2 years of postnatal life. Main outcome: Achievement of a target saturation of 85% at 15 min of life. Secondary outcomes: acute complications during delivery; chronic complications (BPD, ROP, IPVH); mortality in the neonatal period.
Sponsor: Fundacion Para La Investigacion Hospital La Fe
Current Primary Outcome: Achievement of a targeted saturation of 85% at 15 min of life. [ Time Frame: 30 min ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Neonatal mortality [ Time Frame: 28 days of life ]
- Oxidative stress [ Time Frame: at day 1, 2 and 7 ]
- Bronchopulmonary dysplasia [ Time Frame: 36 weeks postconceptional age ]
- Retinopathy of prematurity [ Time Frame: 40 weeks postconceptional ]
- Neurodevelopment [ Time Frame: 24 months postnatal ]
Original Secondary Outcome: Same as current
Information By: Fundacion Para La Investigacion Hospital La Fe
Dates:
Date Received: June 28, 2007
Date Started: April 2005
Date Completion:
Last Updated: October 14, 2008
Last Verified: October 2008