Trial Outcomes & Findings for Cerebral Oxygenation and Autoregulation in Preterm Infants (NCT NCT02147769)

NCT ID: NCT02147769

Last Updated: 2020-04-07

Results Overview

Participants will be followed for the outcome of death prior to hospital discharge.

• Recruitment status: COMPLETED
• Target enrollment: 111 participants
• Primary outcome timeframe: 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.
• Results posted on: 2020-04-07

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	111
Overall Study COMPLETED	111
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cerebral Oxygenation and Autoregulation in Preterm Infants

Baseline characteristics by cohort

Measure	Preterm Infants Monitored With NIRS n=111 Participants 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.
Age, Categorical <=18 years	111 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	26 weeks gestational age STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	29 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants
Race (NIH/OMB) White	56 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Death or Neuroradiographic abnormality at baseline	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Preterm Infants Monitored With NIRS n=111 Participants 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.

Mortality Before Hospital Discharge

11 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Preterm Infants Monitored With NIRS n=111 Participants 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.

Severe Central Nervous System (CNS) Morbidity

14 Participants

Adverse Events

Preterm Infants Monitored With NIRS

Serious events: 14 serious events

Other events: 0 other events

Deaths: 11 deaths

Serious adverse events

Measure

Preterm Infants Monitored With NIRS n=111 participants at risk 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.

Nervous system disorders CNS abnormality

12.6% 14/111 • Number of events 14 • Adverse events were collected until hospital discharge or 6 months (whichever occurred first).

Other adverse events

Adverse event data not reported

Additional Information

Valerie Chock, MD

Stanford University

Phone: 650-723-5711

Email: vchock@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place