Regional Neonatal ICU and CCN, University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
NCT Number: NCT03333174
To determine if servo-controlled oxygen environment is associated with reduction in (a) bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes
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All sexes
Interventional
Not applicable
Birmingham, Alabama, 35233, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Infants eligible for full care and resuscitation as necessary, and surviving beyond 24 h of age
Enrollment in main study protocol (Aim 1 of PreVENT Apnea) at <1 week post-natal age
This study will enroll the subset of infants from Aim 1 who are receiving oxygen supplementation at 32w and 36w PMA, and are not judged too unstable by the Attending neonatologist
Informed consent from parent/guardian
Exclusion criteria
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)
Time frame: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
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 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 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%
University of Alabama at Birmingham
Other
Prematurity-Related Ventilatory Control (PRE-VENT): Role in Respiratory Outcomes Clinical Research Centers (CRC) - Specific Aim 3
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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