Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2011-005717-36-ES
EUCTR2011-005717-36-ES
Active, not recruiting
Phase 1

Extremely low gestational age neonates randomly an assigned to be blindly resuscitated with 21% vs. 60% oxygen: influence upon mortality and chronic conditions in the neonatal period.

Instituto de Investigación Sanitaria La Fe0 sites304 target enrollmentMarch 29, 2012
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Instituto de Investigación Sanitaria La Fe
Enrollment
304
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 29, 2012
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Instituto de Investigación Sanitaria La Fe

Eligibility Criteria

Inclusion Criteria

  • •Preterm infants with gestational age of 30 weeks or less gestation born in tertiary referral centers and needing resuscitation/stabilization maneuvers with positive pressure ventilation immediately after birth
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 760
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Uncertainty about gestational age
  • •Refusal to participate (parents/guardian)
  • •Not fulfilling study protocol
  • •Decoding in the delivery room
  • •Chromosomopaties
  • •Major malformations

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Not Applicable
Prediction of mild developmental delay and typical outcome in at risk preterm infants.Infants born at less than 1500g or 32 weeks gestation with increased risk for neurodevelopmental delay.Reproductive Health and Childbirth - Complications of newborn
ACTRN12614000480684Mrs Rebecca Caesar104
Active, not recruiting
Phase 1
Extremely low gestational age infants' PARAcetamol StudyOpen ductus arteriosus of a premature infantTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
EUCTR2018-000566-11-FIniversity of Oulu40
Terminated
Not Applicable
Improving child and parent outcomes after preterm birth using a web-based early intervention program (e-prem)
ACTRN12614000906651Murdoch Childrens Research Institute103
Completed
Not Applicable
Can omega 3 fatty acids improve respiratory outcomes in preterm infants?Preterm infantsBronchopulmonary dysplasiaRespiratory - Other respiratory disorders / diseasesReproductive Health and Childbirth - Complications of newborn
ACTRN12612000503820South Australian Health and Medical Research Institute1,273
Recruiting
Phase 1
Human milk lyophilisate - Phase 1 and 2 study: safety, tolerability and effectivenessPreterm newbornHuman MilkHuman Milk BancNewrbornM01.060.703.520M01.060.703.520.520A12.200.467N02.278.065.600
RBR-8nnpfmConselho Nacional de Desenvolvimento Científico e Tecnológico