Trial Outcomes & Findings for Use of NIRS in Preterm Population Born at Altitude (NCT NCT04639583)

NCT ID: NCT04639583

Last Updated: 2024-05-29

Results Overview

Measure cRSO2 for the first 96 hours of life in infants born preterm.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: first 96 hours of life
• Results posted on: 2024-05-29

Participant Flow

Participant milestones

Measure	Observational Arm Any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life. It will be the goal to apply the NIRS sensors in the first 12 hours of life. All infants will have the same treatment if in the study, but clinicians will not be able to see the data obtained so that there is no clinical interpretation during this time. Near-infrared spectroscopy (NIRS) utilization: The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured.
Overall Study STARTED	21
Overall Study NIRS Monitoring	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of NIRS in Preterm Population Born at Altitude

Baseline characteristics by cohort

Measure	Observational Arm n=20 Participants Any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life. It will be the goal to apply the NIRS sensors in the first 12 hours of life. All infants will have the same treatment if in the study, but clinicians will not be able to see the data obtained so that there is no clinical interpretation during this time. Near-infrared spectroscopy (NIRS) utilization: The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured.
Age, Categorical <=18 years	20 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	28.5 weeks n=93 Participants
Sex: Female, Male Female	13 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants
Race/Ethnicity, Customized Hispanic latino	10 Participants n=93 Participants
Race/Ethnicity, Customized white	6 Participants n=93 Participants
Race/Ethnicity, Customized American Indian Alaska Native	3 Participants n=93 Participants
Race/Ethnicity, Customized other OR unknown	1 Participants n=93 Participants
Region of Enrollment United States	20 participants n=93 Participants
rcSO2 (cerebral regional oxygen saturation)	73.5 % of rcSO2 n=93 Participants
CRIB-II (Clinical Risk Index for Babies) II Scoring System	8.5 score n=93 Participants
cFTOE (cerebral fractional tissue oxygen extraction)	21.9 % of cFTOE n=93 Participants

PRIMARY outcome

Timeframe: first 96 hours of life

Measure cRSO2 for the first 96 hours of life in infants born preterm.

Outcome measures

Measure	Observational Arm n=20 Participants Any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life. It will be the goal to apply the NIRS sensors in the first 12 hours of life. All infants will have the same treatment if in the study, but clinicians will not be able to see the data obtained so that there is no clinical interpretation during this time. Near-infrared spectroscopy (NIRS) utilization: The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured.	Secondary Outcome ROP Infants requiring treatment for ROP	Secondary Outcome Sepsis Infants with late onset sepsis	Secondary Outcome PDA Infant with patent ductus arterioles requiring treatment	Secondary Outcome NEC Infants diagnosed with necrotizing enterocolitis
Cerebral Regional Oxygen Saturation (cRSO2)	73.4 percent rcSO2 Interval 15.0 to 95.0	—	—	—	—

SECONDARY outcome

Timeframe: From birth until the end of the birth hospitalization, which would be discharge home or death, whichever occurs first. Estimated time is up to 6 months of age.

Population: Infants with complications of prematurity

Additional items recorded to determine if there is any correlation with the cRSO2 values, including death, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, duration of supplemental oxygen required, time to taking full volume feeds via nippling, and hospital length of stay.

Outcome measures

Measure	Observational Arm n=20 Participants Any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life. It will be the goal to apply the NIRS sensors in the first 12 hours of life. All infants will have the same treatment if in the study, but clinicians will not be able to see the data obtained so that there is no clinical interpretation during this time. Near-infrared spectroscopy (NIRS) utilization: The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured.	Secondary Outcome ROP n=20 Participants Infants requiring treatment for ROP	Secondary Outcome Sepsis n=20 Participants Infants with late onset sepsis	Secondary Outcome PDA n=20 Participants Infant with patent ductus arterioles requiring treatment	Secondary Outcome NEC n=20 Participants Infants diagnosed with necrotizing enterocolitis
Incidence of Major Complications of Prematurity	9 number of infant with condition	2 number of infant with condition	3 number of infant with condition	3 number of infant with condition	2 number of infant with condition

Adverse Events

Observational Arm

Serious events: 19 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Observational Arm n=21 participants at risk Any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life. It will be the goal to apply the NIRS sensors in the first 12 hours of life. All infants will have the same treatment if in the study, but clinicians will not be able to see the data obtained so that there is no clinical interpretation during this time. Near-infrared spectroscopy (NIRS) utilization: The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured.
Nervous system disorders Intraventricular hemorrhage	42.9% 9/21 • birth until discharge from birth hospitalization (up to 1 year of age)
Eye disorders Retinopathy of Prematurity	9.5% 2/21 • birth until discharge from birth hospitalization (up to 1 year of age)
Gastrointestinal disorders Necrotizing enterocolitis	9.5% 2/21 • birth until discharge from birth hospitalization (up to 1 year of age)
Immune system disorders Late onset sepsis	14.3% 3/21 • birth until discharge from birth hospitalization (up to 1 year of age)
Cardiac disorders Patent Ductus Arteriosus	14.3% 3/21 • birth until discharge from birth hospitalization (up to 1 year of age)

Other adverse events

Adverse event data not reported

Additional Information

Jessie Maxwell, MD, MBA

University of New Mexico

Phone: 505-272-3967

Email: JRMaxwell@salud.unm.edu

Results disclosure agreements

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