An interventional study of Cardiorespiratory monitoring in Infant,Premature, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 1 Day to 15 Days. Per ClinicalTrials.gov, last updated 2021-09-21.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
To determine if late (at or beyond postnatal day 14) mild permissive hypercapnia is associated with reduction in apnea, bradycardia, and hypoxemic episodes and with improved stability of oxygenation.
Preterm infants who remain intubated or on nasal mechanical ventilation (IMV) at 14 days postnatal age, meet blood gas criteria, have transcutaneous carbondioxide (TcCO2) monitoring with TcCO2 values that trend and correlate appropriately with PaCO2, and are not judged too unstable by Attending neonatologist will qualify.
The investigators will use the data from the 96 hours of intensive multiparametric physiologic monitoring at 2 weeks postnatal age.
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 randomly assigned: Intervention 1 (24-48h of data), Intervention 2 (48-72h of data) and Intervention 3 (72-96h of data).
Exclusion Criteria:
The investigators will evaluate the effects of attempts to increase blood carbon dioxide levels within a narrow range of 5 mm Hg (well within the range of usual clinical practice) in a cross-over manner for 24 hours at a time, over a 4-day period, and use Cardiorespiratory Monitoring to evaluate control of breathing. The investigators will attempt to adjust PCO2 by 5 mm Hg higher from baseline (to max of 70 mm Hg), as long as pH is \>7.2. The first 24 hours of the 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 randomly assigned: Intervention 1 (24-48h of data; Increase TcCO2 by 5 mm Hg), Intervention 2 (48-72h; TcCO2 back to baseline), and Intervention 3 (72-96h; increase TcCO2 again by 5 mm Hg).
Diagnostic Test: Cardiorespiratory monitoring
The investigators will evaluate the effects of attempts to decrease blood carbon dioxide levels within a narrow range of 5 mm Hg (well within the range of usual clinical practice) in a cross-over manner for 24 hours at a time, over a 4-day period, and use Cardiorespiratory Monitoring to evaluate control of breathing. The investigators will attempt to adjust PCO2 by 5 mm Hg lower than baseline (to minimum of 40 mm Hg), as long as pH is \<7.45.
Diagnostic Test: Cardiorespiratory monitoring
We 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).
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 targeted transcutaneous carbondioxide (TcCO2)
Bradycardic episode
Bradycardic episode defined as heart rate (HR) \<100/min for \>10 seconds
Time frame: During 24 hour time periods with targeted TcCO2
Apnea episodes
Apnea defined as Respiratory Rate (RR)=0 for \>20 seconds, or RR=0 for \>10 seconds + SpO2 \<85% or HR \<100/min
Time frame: During 24 hour time periods with targeted TcCO2
Hypoxemic time
Hypoxemic time defined as duration of time with SpO2 \<85%
Time frame: During 24 hour time periods with targeted TcCO2
Bronchopulmonary dysplasia (BPD)
BPD defined using physiologic definition at 36w Post-Menstrual Age (PMA)
Time frame: 36 weeks PMA
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University of Alabama at Birmingham