To determine if servo-controlled oxygen environment is associated with reduction in (a) bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes
This study will enroll the subset of infants enrolled in the main study (PreVENT Aim 1; 401-1000g at birth and/or 22w 0d-28w 6d; enrolled at \<1 week postnatal age; eligible for full care and surviving beyond 24 hours, with informed consent; and with no major malformations) who are receiving oxygen supplementation at 32w and 36w postmenstrual age (PMA), and are not judged too unstable by the Attending neonatologist. For infants on oxygen supplementation at 32w PMA, the investigators will use data from the 96 hours of intensive multiparametric physiologic monitoring at 32w PMA. For infants on oxygen supplementation at 36w PMA, we will use the 96 hours of intensive multiparametric physiologic monitoring at 36w PMA as well as data from the sleep study. The first 24 hours of data collection will be the baseline data. Over the next 72 hours, the investigators will evaluate 3 interventions in a cross-over manner with the initial intervention (cannula or oxygen environment) randomly assigned: Intervention 1 (24-48h of data), Intervention 2 (48-72h of data) and Intervention 3 (72-96h of data).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
The investigators will use high resolution physiologic monitoring of Heart Rate, Respiratory Rate, Pulse oximetry, (and near-infrared monitoring as well as microcapnography in selected infants) to evaluate control of breathing (apnea, bradycardia, desaturations)
Regional Neonatal ICU and CCN, University of Alabama at Birmingham
Birmingham, Alabama, United States
Hypoxemic episode
Hypoxemic episode defined as as oxygen saturation by pulse oximetry (SpO2) \<85% for \>10 seconds
Time frame: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Bradycardic episode
Bradycardic episode defined as heart rate (HR) \<100/min for \>10 seconds
Time frame: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Apnea episodes
Apnea defined as Respiratory Rate (RR)=0 for \>20 seconds, or RR=0 for \>10 seconds + oxygen saturation by pulse oximetry (SpO2) \<85% or heart rate (HR) \<100/min
Time frame: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Hypoxemic time defined as duration of time with SpO2 <85%
Hypoxemic time defined as duration of time with SpO2 \<85%
Time frame: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
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