At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 88 enrolled
Drug / intervention
Resuscitation +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Achievement of a Targeted Saturation in Extremely Low Gestational Age Neonates Resuscitated With Low or High Oxygen Concentration: A Prospective Randomized Trial
Fundacion Para La Investigacion Hospital La Fe·interventional·Posted Jul 2, 2007·Updated Oct 15, 2008
In Brief
A Phase 3 clinical trial evaluating Resuscitation for Birth Asphyxia and Premature Birth. Completed, enrolled 88 participants across 1 site.
Detailed Summary
The investigators hypothesize that using low oxygen concentrations during resuscitation of extremely premature infants will avoid oxidative stress derived damage and improve outcome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBirth Asphyxia, Premature Birth
CountriesSpain
CollaboratorsInstituto de Salud Carlos III
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2005
First PostedJul 2007
Primary CompletionMar 2008
Study CompletionSep 2008
TodayJul 2026
First PostedJul 2, 2007
Enrollment StartApr 1, 2005
Primary CompletionMar 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 19 years ago
Interventions
Resuscitationprocedure
Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-88%
Resuscitationprocedure
Oxygen inspiratory fraction needed to keep oxygen saturation in the preset limits of 90-93%