An observational study in Respiratory Distress Syndrome of Prematurity, sponsored by Hospital General Universitario Gregorio Marañon. Status unknown. Open to participants aged 24 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2021-10-25.
Sponsored by Hospital General Universitario Gregorio Marañon · Observational
Respiratory distress syndrome of prematurity (RDSP) is an acute respiratory condition that occurs in preterm infants due to pulmonary surfactant deficiency.
Exogenous surfactant administration is a crucial therapeutic measure in the management of RDSP, being the 'less invasive surfactant administration technique' (LISA) the gold standard, according to the latest reviews.
Oximetry based on near-infrared spectroscopy is a non-invasive monitoring modality that provides continuous information on the degree of regional hemoglobin saturation present in the underlying tissue, mainly in the venous compartment. It is thus, a reflection of the balance between oxygen supply and demand of oxygen to the tissues.
We intend to perform a prospective analysis of newborns under 32 weeks of gestational age who require surfactant administration, as we wish to study cerebral and renal perfusion by oximetry in the group of patients who receive surfactant by LISA and in the group of patients who receive surfactant via endotracheal tube (patients intubated at birth for stabilization), since there are few data published in the literature.
Our main hypothesis is that the administration of surfactant by LISA technique does not negatively influence cerebral and renal oximetry.
Our secondary hypothesis is that patients requiring intubation at birth will present greater hemodynamic and respiratory instability in the first 72 hours of life, with a greater decrease in cerebral and renal oximetry with the administration of surfactant, compared to the group that does not require intubation at birth.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Hospital General Universitario Gregorio Marañon is the lead sponsor of 59 studies on the registry; 6 are open to participants now.
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Patients less than 32 weeks gestational age born in our center (Hospital General Universitario Gregorio Marañon) who require surfactant administration will be included
Exclusion Criteria:
Other: oximetry monitoring
Other: oximetry monitoring
monitoring oximetry in both groups using the INVOS™ system 5100C Oximeter
to evaluate the impact on cerebral and renal oximetry in preterm infants less than 32 weeks who are administered surfactant
Time frame: oximetry monitoring first 24 hours after birth
No study locations are listed for this record.
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
Hospital General Universitario Gregorio Marañon