An observational study in Intraventricular Hemorrhage of Prematurity and Complications of Prematurity, sponsored by Stanford University. Completed at 7 sites in United States. Open to participants aged Up to 24 Hours. Per ClinicalTrials.gov, last updated 2020-04-07.
Sponsored by Stanford University · Observational
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.
2,557 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 111 is close to the median of 112 across 778 observational studies indexed under Premature Birth.
Browse Premature Birth studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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All inborn preterm infants with birth weight \<=1250 grams and with an indwelling arterial catheter already in place are eligible for study enrollment if they are \<24 hours old at the time of enrollment. These preterm infants are at risk for impaired cerebral autoregulation and may undergo non-invasive monitoring of cerebral oxygenation using near-infrared spectroscopy (NIRS).
Exclusion Criteria:
All infants enrolled in the study will be monitored with cerebral near-infrared spectroscopy (NIRS monitoring) to measure cerebral oxygenation levels in the first 96 hours of life. Mean arterial blood pressure will simultaneously be monitored.
Device: NIRS monitoring
All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure.
Mortality Before Hospital Discharge
Participants will be followed for the outcome of death prior to hospital discharge.
Time frame: Outcome measure will be assessed at the time of subject's initial discharge from the hospital (on average by 40 weeks postmenstrual age), but at a maximum of 1 year of life.
Severe Central Nervous System (CNS) Morbidity
Routine cranial ultrasound obtained within the first ten days of life will be utilized to detect grade 3 or 4 intraventricular hemorrhage, periventricular leukomalacia, significant ventriculomegaly, or white matter abnormalities.
Time frame: Outcome measure will be assessed on day 10 of life. Participants will be followed for neuroradiographic evidence of CNS morbidity in the first ten days of life
| Milestone | Preterm Infants Monitored With NIRS |
|---|---|
| Started | 111 |
| Completed | 111 |
| Not completed | 0 |
Participants will be followed for the outcome of death prior to hospital discharge.
| Participants | Preterm Infants Monitored With NIRS |
|---|---|
| Mortality Before Hospital Discharge | 11 |
Routine cranial ultrasound obtained within the first ten days of life will be utilized to detect grade 3 or 4 intraventricular hemorrhage, periventricular leukomalacia, significant ventriculomegaly, or white matter abnormalities.
| Participants | Preterm Infants Monitored With NIRS |
|---|---|
| Severe Central Nervous System (CNS) Morbidity | 14 |
Collected over Adverse events were collected until hospital discharge or 6 months (whichever occurred first).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Preterm Infants Monitored With NIRS | 11/111 (9.9%) | 14/111 (12.6%) | 0/111 (0%) |
| Event | Preterm Infants Monitored With NIRS |
|---|---|
| CNS abnormalityNervous system disorders | 14/111 |
| Age, Categorical(Participants) | Preterm Infants Monitored With NIRS |
|---|---|
| <=18 years | 111 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(weeks gestational age) | Preterm Infants Monitored With NIRS |
|---|---|
| Mean | 26 ± 1.7 |
| Sex: Female, Male(Participants) | Preterm Infants Monitored With NIRS |
|---|---|
| Female | 55 |
| Male | 56 |
| Race (NIH/OMB)(Participants) | Preterm Infants Monitored With NIRS |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 29 |
| Native Hawaiian or Other Pacific Islander | 3 |
| Black or African American | 18 |
| White | 56 |
| More than one race | 5 |
| Unknown or Not Reported | 0 |
| Death or Neuroradiographic abnormality at baseline(Participants) | Preterm Infants Monitored With NIRS |
|---|---|
| Count of participants | 0 |
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