Oxygen Toxicity in the Resuscitation in Extremely Premature Infants (OXTOX)
The investigators hypothesize that using low oxygen concentrations during resuscitation of extremely premature infants will avoid oxidative stress derived damage and improve outcome.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Achievement of a Targeted Saturation in Extremely Low Gestational Age Neonates Resuscitated With Low or High Oxygen Concentration: A Prospective Randomized Trial|
- Achievement of a targeted saturation of 85% at 15 min of life. [ Time Frame: 30 min ] [ Designated as safety issue: Yes ]
- Neonatal mortality [ Time Frame: 28 days of life ] [ Designated as safety issue: No ]
- Oxidative stress [ Time Frame: at day 1, 2 and 7 ] [ Designated as safety issue: No ]
- Bronchopulmonary dysplasia [ Time Frame: 36 weeks postconceptional age ] [ Designated as safety issue: No ]
- Retinopathy of prematurity [ Time Frame: 40 weeks postconceptional ] [ Designated as safety issue: No ]
- Neurodevelopment [ Time Frame: 24 months postnatal ] [ Designated as safety issue: No ]
|Study Start Date:||April 2005|
|Study Completion Date:||September 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Low saturation group of premature infants that will be kept within preset limits of 85-89%
Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-88%
Active Comparator: HOX
HOX group of premature infants will be kept within preset saturation limits of 90-93%
Oxygen inspiratory fraction needed to keep oxygen saturation in the preset limits of 90-93%
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494702
|Servicio de Neonatologia|
|Valencia, Spain, 46009|
|Principal Investigator:||Maximo Vento, Phd, Md||Hospital Universitario La Fe|