Oxygen Toxicity in the Resuscitation in Extremely Premature Infants - Full Text View

Purpose

The investigators hypothesize that using low oxygen concentrations during resuscitation of extremely premature infants will avoid oxidative stress derived damage and improve outcome.

Condition	Intervention	Phase
Birth Asphyxia Premature Birth	Procedure: Resuscitation	Phase 3

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy Premature Babies

U.S. FDA Resources

Further study details as provided by Fundacion Para La Investigacion Hospital La Fe:

Primary Outcome Measures:

Achievement of a targeted saturation of 85% at 15 min of life. [ Time Frame: 30 min ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Enrollment:	88
Study Start Date:	April 2005
Study Completion Date:	September 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LOX Low saturation group of premature infants that will be kept within preset limits of 85-89%	Procedure: Resuscitation 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%	Procedure: Resuscitation Oxygen inspiratory fraction needed to keep oxygen saturation in the preset limits of 90-93%

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	up to 3 Minutes
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Prematurity of less than 28 weeks gestation

Exclusion Criteria:

Severe malformations
Chromosomopathies
Informed consent not signed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494702

Locations

Spain
Servicio de Neonatologia
Valencia, Spain, 46009

Sponsors and Collaborators

Fundacion Para La Investigacion Hospital La Fe

Instituto de Salud Carlos III

Investigators

Principal Investigator:

Maximo Vento, Phd, Md

Hospital Universitario La Fe

More Information

Publications:

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.

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.

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. Erratum in: J Pediatr. 2003 Jun;142(6):616.

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.

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. Epub 2004 Sep 20. Review.

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. Epub 2005 Sep 1.

Saugstad OD, Ramji S, Vento M. Oxygen for newborn resuscitation: how much is enough? Pediatrics. 2006 Aug;118(2):789-92. No abstract available.

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 Apr 5; [Epub ahead of print]

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Escrig R, Arruza L, Izquierdo I, Villar G, Sáenz 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.

Responsible Party:	INSTITUTO DE SALUD CARLOS III -MINISTERIO DE SANIDAD Y CONSUMO -SPAIN, MAXIMO VENTO
ClinicalTrials.gov Identifier:	NCT00494702 History of Changes
Other Study ID Numbers:	PIO51O5, FISPI05105
Study First Received:	June 28, 2007
Last Updated:	October 14, 2008
Health Authority:	Spain: Ministry of Health and Consumption

Keywords provided by Fundacion Para La Investigacion Hospital La Fe:

Asphyxia
Resuscitation
Oxidative stress
Prematurity
Follow up

Additional relevant MeSH terms:

Asphyxia
Asphyxia Neonatorum
Premature Birth
Death
Pathologic Processes

Wounds and Injuries
Infant, Newborn, Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on May 16, 2013

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