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| ID | Type | Description | Link |
|---|---|---|---|
| FISPI05105 |
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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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The investigators hypothesize that using low oxygen concentrations during resuscitation of extremely premature infants will avoid oxidative stress derived damage and improve outcome.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LOX | Experimental | Low saturation group of premature infants that will be kept within preset limits of 85-89% |
|
| HOX | Active Comparator | HOX group of premature infants will be kept within preset saturation limits of 90-93% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resuscitation | Procedure | Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-88% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of a targeted saturation of 85% at 15 min of life. | 30 min |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal mortality | 28 days of life | |
| Oxidative stress | at day 1, 2 and 7 | |
| Bronchopulmonary dysplasia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maximo Vento, Phd, Md | Hospital Universitario La Fe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servicio de Neonatologia | Valencia | Valencia | 46009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11335737 | Background | Vento M, Asensi M, Sastre J, Garcia-Sala F, Pallardo FV, Vina J. Resuscitation with room air instead of 100% oxygen prevents oxidative stress in moderately asphyxiated term neonates. Pediatrics. 2001 Apr;107(4):642-7. doi: 10.1542/peds.107.4.642. | |
| 12537311 | Background | Vento M, Asensi M, Sastre J, Lloret A, Garcia-Sala F, Minana JB, Vina J. Hyperoxemia caused by resuscitation with pure oxygen may alter intracellular redox status by increasing oxidized glutathione in asphyxiated newly born infants. Semin Perinatol. 2002 Dec;26(6):406-10. doi: 10.1053/sper.2002.37312. |
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| ID | Term |
|---|---|
| D001238 | Asphyxia Neonatorum |
| D047928 | Premature Birth |
| D001237 | Asphyxia |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
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| ID | Term |
|---|---|
| D012151 | Resuscitation |
| ID | Term |
|---|---|
| D004638 | Emergency Treatment |
| D013812 | Therapeutics |
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| Resuscitation | Procedure | Oxygen inspiratory fraction needed to keep oxygen saturation in the preset limits of 90-93% |
|
| 36 weeks postconceptional age |
| Retinopathy of prematurity | 40 weeks postconceptional |
| Neurodevelopment | 24 months postnatal |
| 12640369 | Background | Vento M, Asensi M, Sastre J, Lloret A, Garcia-Sala F, Vina J. Oxidative stress in asphyxiated term infants resuscitated with 100% oxygen. J Pediatr. 2003 Mar;142(3):240-6. doi: 10.1067/mpd.2003.91. |
| 12897277 | Background | Saugstad OD, Ramji S, Irani SF, El-Meneza S, Hernandez EA, Vento M, Talvik T, Solberg R, Rootwelt T, Aalen OO. Resuscitation of newborn infants with 21% or 100% oxygen: follow-up at 18 to 24 months. Pediatrics. 2003 Aug;112(2):296-300. doi: 10.1542/peds.112.2.296. |
| 15452400 | Background | Saugstad OD, Ramji S, Vento M. Resuscitation of depressed newborn infants with ambient air or pure oxygen: a meta-analysis. Biol Neonate. 2005;87(1):27-34. doi: 10.1159/000080950. Epub 2004 Sep 20. |
| 16141440 | Background | Vento M, Sastre J, Asensi MA, Vina J. Room-air resuscitation causes less damage to heart and kidney than 100% oxygen. Am J Respir Crit Care Med. 2005 Dec 1;172(11):1393-8. doi: 10.1164/rccm.200412-1740OC. Epub 2005 Sep 1. |
| 16882835 | Background | Saugstad OD, Ramji S, Vento M. Oxygen for newborn resuscitation: how much is enough? Pediatrics. 2006 Aug;118(2):789-92. doi: 10.1542/peds.2006-0832. No abstract available. |
| 17426659 | Background | Bookatz GB, Mayer CA, Wilson CG, Vento M, Gelfand SL, Haxhiu MA, Martin RJ. Effect of supplemental oxygen on reinitiation of breathing after neonatal resuscitation in rat pups. Pediatr Res. 2007 Jun;61(6):698-702. doi: 10.1203/pdr.0b013e3180534171. |
| 18450889 | Derived | Escrig R, Arruza L, Izquierdo I, Villar G, Saenz P, Gimeno A, Moro M, Vento M. Achievement of targeted saturation values in extremely low gestational age neonates resuscitated with low or high oxygen concentrations: a prospective, randomized trial. Pediatrics. 2008 May;121(5):875-81. doi: 10.1542/peds.2007-1984. |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |