Premature Birth Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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