Oxygen Toxicity in the Resuscitation in Extremely Premature Infants (OXTOX)
|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|