Intraventricular Hemorrhage of Prematurity, Complications of Prematurity
Conditions
Keywords
cerebral autoregulation, preterm, near-infrared spectroscopy
Brief 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.
Interventions
DEVICENIRS monitoring
All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure.
Sponsors
Medtronic - MITG
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality Before Hospital Discharge | 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. | Participants will be followed for the outcome of death prior to hospital discharge. |
| Severe Central Nervous System (CNS) Morbidity | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Preterm Infants Monitored With NIRS 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.
NIRS monitoring: All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure. | 111 |
| Total | 111 |
Baseline characteristics
| Characteristic | Preterm Infants Monitored With NIRS |
|---|---|
| Age, Categorical <=18 years | 111 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 26 weeks gestational age STANDARD_DEVIATION 1.7 |
| Death or Neuroradiographic abnormality at baseline | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 29 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 56 Participants |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 11 / 111 |
| other Total, other adverse events | 0 / 111 |
| serious Total, serious adverse events | 14 / 111 |
Outcome results
Primary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preterm Infants Monitored With NIRS | Mortality Before Hospital Discharge | 11 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preterm Infants Monitored With NIRS | Severe Central Nervous System (CNS) Morbidity | 14 Participants |