Prematurity; Extreme
Conditions
Brief summary
Near-infrared spectroscopy (NIRS), is a technology that can provide continuous, non-invasive monitoring of oxygenation in tissue. The objective of this study is to obtain the cerebral regional oxygen saturation (cRSO2) in a preterm population that is born at altitude to determine if the range of normal values is different than those obtained at sea level.
Interventions
DEVICENear-infrared spectroscopy (NIRS) utilization
The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured.
Sponsors
University of New Mexico
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The study will be a prospective observational study, in which any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life.
Eligibility
Sex/Gender
ALL
Age
0 Hours to 24 Hours
Healthy volunteers
No
Inclusion criteria
* Infant must be \<32 weeks' gestational age at time of delivery. * Consenting mother/guardian of the infant must speak English. Other languages are not being included due to the need of a translator being brought into the unit, which adds risk to the vulnerable population. Additionally, as the time to consent is a narrow window, adding the complexity of getting a translator may delay the ability to get consent and thus make it more difficult to enroll patients. * Infants that require blood transfusions during the monitoring time may be included.
Exclusion criteria
* Any known cardiac anomaly or other anomaly which may impair perfusion and blood flow. * Infant born after placental abruption or concern for extreme blood loss immediately after birth. * Unable to consent the mother/guardian due to maternal health issues after delivering (eg requiring intubation or sedation after the delivery). * Mothers/guardians that are prisoners, as the study team would like to have continuing communication with the mother during the study period as needed. * Mothers/guardians that are \<18 years of age will not be approached for consent. * Any mother/guardian that is not able to consent due to having a legal representative will not be approached for consent in this study. * Any infant that is planned to be placed for adoption * Infant is greater than 24 hours of age at time of consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Regional Oxygen Saturation (cRSO2) | first 96 hours of life | Measure cRSO2 for the first 96 hours of life in infants born preterm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Major Complications of Prematurity | 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. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Observational Arm |
|---|---|
| Age, Categorical <=18 years | 20 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 28.5 weeks |
| cFTOE (cerebral fractional tissue oxygen extraction) | 21.9 % of cFTOE |
| CRIB-II (Clinical Risk Index for Babies) II Scoring System | 8.5 score |
| Race/Ethnicity, Customized American Indian Alaska Native | 3 Participants |
| Race/Ethnicity, Customized Hispanic latino | 10 Participants |
| Race/Ethnicity, Customized other OR unknown | 1 Participants |
| Race/Ethnicity, Customized white | 6 Participants |
| rcSO2 (cerebral regional oxygen saturation) | 73.5 % of rcSO2 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 19 / 21 |
Outcome results
Primary
Cerebral Regional Oxygen Saturation (cRSO2)
Measure cRSO2 for the first 96 hours of life in infants born preterm.
Time frame: first 96 hours of life
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Observational Arm | Cerebral Regional Oxygen Saturation (cRSO2) | 73.4 percent rcSO2 |
Secondary
Incidence of Major 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.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Observational Arm | Incidence of Major Complications of Prematurity | 9 number of infant with condition |
| Secondary Outcome ROP | Incidence of Major Complications of Prematurity | 2 number of infant with condition |
| Secondary Outcome Sepsis | Incidence of Major Complications of Prematurity | 3 number of infant with condition |
| Secondary Outcome PDA | Incidence of Major Complications of Prematurity | 3 number of infant with condition |
| Secondary Outcome NEC | Incidence of Major Complications of Prematurity | 2 number of infant with condition |