Regional Neonatal ICU and CCN, University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
NCT Number: NCT03333161
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.
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All sexes
Interventional
Not applicable
Birmingham, Alabama, 35233, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: During 24 hour time periods with targeted transcutaneous carbondioxide (TcCO2)
Hypoxemic episode defined as as oxygen saturation by pulse oximetry (SpO2 )<85% for >10 seconds
Time frame: During 24 hour time periods with targeted TcCO2
Bradycardic episode defined as heart rate (HR) <100/min for >10 seconds
Time frame: During 24 hour time periods with targeted TcCO2
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 defined as duration of time with SpO2 <85%
Time frame: 36 weeks PMA
BPD defined using physiologic definition at 36w Post-Menstrual Age (PMA)
University of Alabama at Birmingham
Other
Prematurity-Related Ventilatory Control (PRE-VENT): Role in Respiratory Outcomes Clinical Research Centers (CRC)
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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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