N/A
N=111
Cerebral Oxygenation and Autoregulation in Preterm Infants
Intraventricular Hemorrhage of Prematurity · Complications of Prematurity
Bottom Line
View on ClinicalTrials.gov: NCT02147769 ↗Enrolled (actual)
111
Serious AEs
12.6%
Results posted
Apr 2020
Primary outcome: Primary: Mortality Before Hospital Discharge — 11 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- NIRS monitoring (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality Before Hospital Discharge |
11 | — |
| PRIMARY Severe Central Nervous System (CNS) Morbidity |
14 | — |
Summary
Premature infants are at high risk for variations in blood pressure and oxygenation during the first few days of life. The immaturity of the premature brain may further predispose these infants to death or the development of neurologic problems. The relationship between unstable blood pressure and oxygen levels and brain injury has not been well elucidated.
This study investigates the utility of near-infrared spectroscopy (NIRS), a non-invasive oxygen-measuring device, to identify preterm infants at highest risk for brain injury or death.
Eligibility Criteria
Inclusion Criteria
- inborn
- birth weight <= 1250 grams
- indwelling arterial catheter in place
- age <24 hours old
Exclusion Criteria
- lethal chromosomal abnormality
- major congenital anomaly
- skin integrity insufficient to allow placement of NIRS sensors
- decision to not provide full intensive care
Data sourced from ClinicalTrials.gov (NCT02147769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.