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

This study has been completed.
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by:
Fundacion Para La Investigacion Hospital La Fe
ClinicalTrials.gov Identifier:
NCT00494702
First received: June 28, 2007
Last updated: October 14, 2008
Last verified: October 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Premature Birth
Asphyxia
Asphyxia Neonatorum
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 16, 2014