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Birth AsphyxiaPhase 3OXTOXNCT00494702

Oxygen Toxicity in the Resuscitation in Extremely Premature Infants

A Phase 3 study testing Resuscitation in people with Birth Asphyxia and Premature Birth, run by Fundacion Para La Investigacion Hospital La Fe at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 1 minute to 3 minutes
Conditions the study is for
Birth Asphyxia, Premature Birth
What is being tested?
Resuscitation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteSpain
Study dates
Apr 2005to Sep 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 minute to 3 minutes
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Prematurity of less than 28 weeks gestation

Who cannot join

  • Severe malformations
  • Chromosomopathies
  • Informed consent not signed

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Servicio de Neonatologia

    Valencia, Valencia, 46009

Other trials in Spain

About this study

Official title: Achievement of a Targeted Saturation in Extremely Low Gestational Age Neonates Resuscitated With Low or High Oxygen Concentration: A Prospective Randomized Trial

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

Read the 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.

Being tested
Resuscitation
Keywords
Asphyxia, Resuscitation, Oxidative stress, Prematurity, Follow up
Medical subject headings
Asphyxia Neonatorum, Premature Birth, Asphyxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ResuscitationProcedure or surgery

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

  • ResuscitationProcedure or surgery

    Oxygen inspiratory fraction needed to keep oxygen saturation in the preset limits of 90-93%

Study groups in NCT00494702
Study groupRoleWhat they receive
LOXExperimentalLow saturation group of premature infants that will be kept within preset limits of 85-89%
Receives: Procedure: Resuscitation
HOXActive comparatorHOX group of premature infants will be kept within preset saturation limits of 90-93%
Receives: Procedure: Resuscitation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 30 min

Secondary outcomes (5)

  1. Neonatal mortality

    Measured: 28 days of life

  2. Oxidative stress

    Measured: at day 1, 2 and 7

  3. Bronchopulmonary dysplasia

    Measured: 36 weeks postconceptional age

  4. Retinopathy of prematurity

    Measured: 40 weeks postconceptional

  5. Neurodevelopment

    Measured: 24 months postnatal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2007 (estimated)
  2. Study startApr 2005
  3. Primary completionMar 2008
  4. Study completionSep 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00494702
Sponsor's protocol ID
PIO51O5
Other IDs
FISPI05105
Acronym
OXTOX
Status last verified
Oct 2008
First submitted
28 Jun 2007
Last updated
15 Oct 2008
Results posted
No
Data monitoring committee
Yes

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. doi: 10.1542/peds.107.4.642.

    PubMed 11335737

  • 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.

    PubMed 12537311

  • 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.

    PubMed 12640369

  • 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.

    PubMed 12897277

  • 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.

    PubMed 15452400

  • 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.

    PubMed 16141440

  • 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.

    PubMed 16882835

  • 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.

    PubMed 17426659

  • 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.

    PubMed 18450889

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Resuscitation in people with Birth Asphyxia and Premature Birth, run by Fundacion Para La Investigacion Hospital La Fe at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Achievement of a targeted saturation of 85% at 15 min of life. (time frame: 30 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00494702, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2008.

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