Cardio-respiratory Events in Preterm Infants During Transition
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|ClinicalTrials.gov Identifier: NCT04123691|
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Cardio-respiratory events (CRE), defined as intermittent episodes of hypoxemia and/or bradycardia, are particularly common among preterm infants. It has been previously shown that CRE result in transient brain hypoxia and hypoperfusion and may represent a possible risk factor for neurodevelopmental impairment and retinopathy of prematurity. The high cardio-respiratory instability typically seen in preterm infants during the first 72 hours of life may influence CRE occurrence, with possible clinical implications. This study aims to characterize CRE features in this transitional period and to evaluate whether specific neonatal and clinical characteristics are associated with different CRE types.
Newborn infants with gestational age (GA) <32 weeks or birth weight (BW) <1500 g are enrolled. Congenital malformations and mechanical ventilation are exclusion criteria. During the first 72 hours, heart rate (HR) and peripheral oxygen saturation (SpO2) are continuously monitored, and an echocardiogram is performed to assess the status of the ductus arteriosus. CRE are clustered into isolated desaturation (ID, SpO2<85%), isolated bradycardia (IB, HR<100 bpm or <70% baseline), combined desaturation and bradycardia (DB, occurrence of the two events within a 60-sec window). According to their duration and SpO2 and/or HR nadir values, CRE are also classified as mild (SpO2 80-84% and HR 80-100 bpm and duration <60 sec), moderate (SpO2 70-79% or HR 80-60 bpm or duration 61-120 sec) or severe (SpO2 <70% or HR <60 bpm or duration >120 sec). A generalized estimating equation (GEE) will be used to examine the impact of relevant variables on CRE type and severity.
|Condition or disease||Intervention/treatment|
|Apnea of Prematurity Apneic Spells of Newborn Nos Patent Ductus Arteriosus Premature Birth Desaturation of Blood Bradycardia Neonatal||Device: pulse oximetry monitoring|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Cardio-respiratory Events in VLBW Preterm Infants During the Transitional Period: Clinical Features and Impact of Neonatal Characteristics.|
|Actual Study Start Date :||February 21, 2018|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||November 2, 2019|
- Device: pulse oximetry monitoring
pulse oximetry monitoring as per routine clinical practice
- Definition of CRE characteristics [ Time Frame: 0-72 hours of life ]Total number of desaturations, bradycardias and combined events
- Time distribution of CRE [ Time Frame: 0-72 hours of life ]Daily incidence of desaturations, bradycardias and combined events
- Effect of neonatal characteristics on CRE type [ Time Frame: 0-72 hours of life ]Generalized estimating equation (GEE) analysis evaluating the effect of GA, uREDF, antenatal steroids, ductal and ventilatory status on CRE type (ID, IB, DB) using multinomial distribution/probit link.
- Effect of neonatal characteristics on CRE severity [ Time Frame: 0-72 hours of life ]Generalized estimating equation (GEE) analysis evaluating the effect of GA, uREDF, antenatal steroids, ductal and ventilatory status on CRE severity (mild, moderate and severe) using multinomial distribution/probit link.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123691
|Contact: Silvia Martini, MD||0039 051 email@example.com|
|Contact: Luigi Corvaglia, Prof||0039 051 firstname.lastname@example.org|
|Sant'Orsola-Malpighi University Hospital||Recruiting|
|Bologna, Emilia-Romagna, Italy, 40138|
|Contact: Silvia Martini, MD 0039 051 2144774|
|Contact: Luigi Corvaglia, Prof 0039 051 2144774|
|Principal Investigator:||Silvia Martini, MD||Sant'Orsola-Malpighi University Hospital, Bologna, Italy|