Birth Asphyxia, Premature Birth
Conditions
Keywords
Asphyxia, Resuscitation, Oxidative stress, Prematurity, Follow up
Brief summary
The investigators hypothesize that using low oxygen concentrations during resuscitation of extremely premature infants will avoid oxidative stress derived damage and improve outcome.
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.
Interventions
Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-88%
Sponsors
Study design
Eligibility
Inclusion criteria
* Prematurity of less than 28 weeks gestation
Exclusion criteria
* Severe malformations * Chromosomopathies * Informed consent not signed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of a targeted saturation of 85% at 15 min of life. | 30 min |
Secondary
| Measure | Time frame |
|---|---|
| Neonatal mortality | 28 days of life |
| Oxidative stress | at day 1, 2 and 7 |
| Bronchopulmonary dysplasia | 36 weeks postconceptional age |
| Retinopathy of prematurity | 40 weeks postconceptional |
| Neurodevelopment | 24 months postnatal |
Countries
Spain