Oxygen Toxicity in the Resuscitation in Extremely Premature Infants

NCT00494702 | Completed Phase 3 DMC

• 2 other identifiers: PIO51O5FISPI05105
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Birth Asphyxia; Premature Birth

Keywords

Asphyxia; Resuscitation; Oxidative stress; Prematurity; Follow up

Outcome Measures

Primary Outcomes (1)

• Achievement of a targeted saturation of 85% at 15 min of life.

  30 min

Secondary Outcomes (5)

• Neonatal mortality

  28 days of life

• Oxidative stress

  at day 1, 2 and 7

• Bronchopulmonary dysplasia

  36 weeks postconceptional age

• Retinopathy of prematurity

  40 weeks postconceptional

• Neurodevelopment

  24 months postnatal

Study Arms (2)

LOX

EXPERIMENTAL

Low saturation group of premature infants that will be kept within preset limits of 85-89%

Procedure: Resuscitation

HOX

ACTIVE COMPARATOR

HOX group of premature infants will be kept within preset saturation limits of 90-93%

Procedure: Resuscitation

Interventions

Resuscitation PROCEDURE

Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-88%

LOX

Eligibility Criteria

• Age: 1 Minute - 3 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Prematurity of less than 28 weeks gestation

You may not qualify if:

• Severe malformations
• Chromosomopathies
• Informed consent not signed

Sponsors & Collaborators

• Fundacion Para La Investigacion Hospital La Fe: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Servicio de Neonatologia

Valencia, Valencia, 46009, Spain

Location

Related Publications (9)

• 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.

  PMID: 11335737 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.

  PMID: 12537311 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.

  PMID: 12640369 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.

  PMID: 12897277 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.

  PMID: 15452400 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.

  PMID: 16141440 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.

  PMID: 16882835 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.

  PMID: 17426659 BACKGROUND

• 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.

  PMID: 18450889 DERIVED

MeSH Terms

Conditions

Asphyxia Neonatorum; Premature Birth; Asphyxia

Interventions

Resuscitation

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Emergency Treatment; Therapeutics

Study Officials

• Maximo Vento, Phd, Md

  Hospital Universitario La Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 28, 2007
• First Posted: July 2, 2007
• Study Start: April 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: September 1, 2008
• Last Updated: October 15, 2008

Record last verified: 2008-10

Locations

ES (1)