Oxygen Toxicity in the Resuscitation in Extremely Premature Infants (OXTOX)
|ClinicalTrials.gov Identifier: NCT00494702|
Recruitment Status : Completed
First Posted : July 2, 2007
Last Update Posted : October 15, 2008
|Condition or disease||Intervention/treatment||Phase|
|Birth Asphyxia Premature Birth||Procedure: Resuscitation||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Achievement of a Targeted Saturation in Extremely Low Gestational Age Neonates Resuscitated With Low or High Oxygen Concentration: A Prospective Randomized Trial|
|Study Start Date :||April 2005|
|Primary Completion Date :||March 2008|
|Study Completion Date :||September 2008|
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%
- Achievement of a targeted saturation of 85% at 15 min of life. [ Time Frame: 30 min ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494702
|Servicio de Neonatologia|
|Valencia, Spain, 46009|
|Principal Investigator:||Maximo Vento, Phd, Md||Hospital Universitario La Fe|