Ignite Creation Date:
2024-05-06 @ 1:48 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04123691
Status:
COMPLETED
Last Update Posted:
2019-11-26
First Post:
2019-10-09
Brief Title:
Cardio-respiratory Events in Preterm Infants During Transition
Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Organization:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study Overview
Official Title:
Cardio-respiratory Events in VLBW Preterm Infants During the Transitional Period Clinical Features and Impact of Neonatal Characteristics
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cardio-respiratory events CRE defined as intermittent episodes of hypoxemia andor 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 SpO285 isolated bradycardia IB HR100 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 andor 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
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 SpO285 isolated bradycardia IB HR100 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 andor 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
Detailed Description:
Background Cardio-respiratory events CRE defined as intermittent hypoxic andor bradycardic episodes are very common among premature infants The poor respiratory drive together with the increased metabolic oxygen consumption and the reduced total blood oxygen carrying capacity of this population significantly enhance CRE frequency and severity
Evidence from animal models has shown that CRE either alone or combined to specific clinical factors ie intrauterine growth restriction support modality need for supplemental oxygen etc can trigger oxidative stress which may contribute to adverse neonatal outcomes In particular a significant association between CRE and the development of retinopathy of prematurity ROP has been largely established with evidence of a positive correlation between ROP severity and CRE duration depth of desaturation and persistency after 3 to 5 weeks of age A critical role for CRE on early brain development has also been suggested by several studies showing a relationship between the ensuing hypoxic burden and poor neurodevelopment from early infancy up to early school age Eventually a possible association between CRE severity and the development of bronchopulmonary dysplasia has been recently reported in very-low-birth-weight VLBW neonates
Most of the available literature on CRE characteristics physiological mechanisms and effects in the premature population however is based on infants aged 2-weeks or older while data from the transitional period defined as the first 72 hours after birth are scarce
The transitional period represents a critical phase of physiological adaptation and may affect several organ systems most notably the heart and the lungs In particular the dynamic cardiovascular changes that characterize the transition from fetal to neonatal circulation may enhance preterm infants cardiorespiratory instability with possible effects on CRE characteristics In turn the hemodynamic and respiratory disturbances that characterize post-natal transition may exacerbate the clinical burden of CRE during this period with possible clinical implications
This study aims to characterize CRE during transitional periods in VLBW preterm infants and to evaluate whether specific neonatal characteristics may have an influence on CRE type and severity
Methods Infants born at S Orsola-Malpighi Hospital are consecutively enrolled in this observational prospective study if fulfilling the following eligibility criteria gestational age GA 32 weeks gestation birth weight 1500 g 0-12 hours of life written informed consent obtained from the parentslegal guardians of each infant
Peripheral oxygen saturation SpO2 and heart rate HR are routinely monitored during hospital stay using a Masimo Radical 7 Masimo Corporation Irvine CA USA pulse oximeter with a 1-Hz sampling frequency
Isolated desaturations ID are defined as SpO2 85 and classified into mild SpO2 80-84 moderate SpO2 70-79 and severe SpO2 70
Isolated bradycardias IB are defined as any HR drop 100 bpm or 30 from baseline values calculated daily over the first 72 hours of life and further stratified into mild HR 80-100 bpm or any drop between 31-50 of the baseline moderate HR 60-79 bpm or any drop between 51-70 of baseline or severe HR 60 bpm or any drop 70 of baseline
Desaturations and bradycardias occurring within a 60-sec time window are considered as combined events DB
Event duration is calculated as the period spent below the SpO2 and HR thresholds described for CRE definition According to their duration CRE are defined as mild 10-60 sec moderate 61-120 sec or severe 120 sec
Neonatal clinical characteristics The following antenatal and neonatal data are tracked down on a specific case report form GA antenatal steroids complete course vs incomplete course or not given evidence of reversed end-diastolic flow at antenatal umbilical Doppler uREDF present vs absent ventilatory status over the first 72 hours of life continuous positive airway pressure CPAP vs nasal cannulas or self-ventilating in air SVIA
A screening echocardiogram is routinely performed at the time of enrollment using an ultrasound scanner CX50 Philips Healthcare with a 12-MHz probe and repeated 6-12 hourly in the presence of a patent ductus arteriosus PDA or 12-24 hourly if there is no evidence of PDA Based on echocardiographic features the ductal status is classified as follows no evidence of PDA noPDA restrictive PDA rPDA restrictive shunt pattern and left atrium to aortic root ratio LAAo ratio 15 hemodynamically significant PDA hsPDA pulsatile shunt pattern LAAo ratio 15 or presence of reversed end-diastolic flow REDF either in the descending aorta or in the anterior cerebral artery
Statistical analysis Generalized estimating equation GEE models will be used to analyze the effect of GA uREDF antenatal steroids ductal and ventilatory status on CRE type ID IB DB and severity mild moderate and severe and the relation of different neonatal characteristics and event types with event duration Variations in the daily number of ID IB and DB over the 3 days of life adjusted for the effective hours of recording will be analyzed using Repeated Measures ANOVA RM-ANOVA IBM SPSS version 250 will be used for statistical analysis The significance level is set at p005
Evidence from animal models has shown that CRE either alone or combined to specific clinical factors ie intrauterine growth restriction support modality need for supplemental oxygen etc can trigger oxidative stress which may contribute to adverse neonatal outcomes In particular a significant association between CRE and the development of retinopathy of prematurity ROP has been largely established with evidence of a positive correlation between ROP severity and CRE duration depth of desaturation and persistency after 3 to 5 weeks of age A critical role for CRE on early brain development has also been suggested by several studies showing a relationship between the ensuing hypoxic burden and poor neurodevelopment from early infancy up to early school age Eventually a possible association between CRE severity and the development of bronchopulmonary dysplasia has been recently reported in very-low-birth-weight VLBW neonates
Most of the available literature on CRE characteristics physiological mechanisms and effects in the premature population however is based on infants aged 2-weeks or older while data from the transitional period defined as the first 72 hours after birth are scarce
The transitional period represents a critical phase of physiological adaptation and may affect several organ systems most notably the heart and the lungs In particular the dynamic cardiovascular changes that characterize the transition from fetal to neonatal circulation may enhance preterm infants cardiorespiratory instability with possible effects on CRE characteristics In turn the hemodynamic and respiratory disturbances that characterize post-natal transition may exacerbate the clinical burden of CRE during this period with possible clinical implications
This study aims to characterize CRE during transitional periods in VLBW preterm infants and to evaluate whether specific neonatal characteristics may have an influence on CRE type and severity
Methods Infants born at S Orsola-Malpighi Hospital are consecutively enrolled in this observational prospective study if fulfilling the following eligibility criteria gestational age GA 32 weeks gestation birth weight 1500 g 0-12 hours of life written informed consent obtained from the parentslegal guardians of each infant
Peripheral oxygen saturation SpO2 and heart rate HR are routinely monitored during hospital stay using a Masimo Radical 7 Masimo Corporation Irvine CA USA pulse oximeter with a 1-Hz sampling frequency
Isolated desaturations ID are defined as SpO2 85 and classified into mild SpO2 80-84 moderate SpO2 70-79 and severe SpO2 70
Isolated bradycardias IB are defined as any HR drop 100 bpm or 30 from baseline values calculated daily over the first 72 hours of life and further stratified into mild HR 80-100 bpm or any drop between 31-50 of the baseline moderate HR 60-79 bpm or any drop between 51-70 of baseline or severe HR 60 bpm or any drop 70 of baseline
Desaturations and bradycardias occurring within a 60-sec time window are considered as combined events DB
Event duration is calculated as the period spent below the SpO2 and HR thresholds described for CRE definition According to their duration CRE are defined as mild 10-60 sec moderate 61-120 sec or severe 120 sec
Neonatal clinical characteristics The following antenatal and neonatal data are tracked down on a specific case report form GA antenatal steroids complete course vs incomplete course or not given evidence of reversed end-diastolic flow at antenatal umbilical Doppler uREDF present vs absent ventilatory status over the first 72 hours of life continuous positive airway pressure CPAP vs nasal cannulas or self-ventilating in air SVIA
A screening echocardiogram is routinely performed at the time of enrollment using an ultrasound scanner CX50 Philips Healthcare with a 12-MHz probe and repeated 6-12 hourly in the presence of a patent ductus arteriosus PDA or 12-24 hourly if there is no evidence of PDA Based on echocardiographic features the ductal status is classified as follows no evidence of PDA noPDA restrictive PDA rPDA restrictive shunt pattern and left atrium to aortic root ratio LAAo ratio 15 hemodynamically significant PDA hsPDA pulsatile shunt pattern LAAo ratio 15 or presence of reversed end-diastolic flow REDF either in the descending aorta or in the anterior cerebral artery
Statistical analysis Generalized estimating equation GEE models will be used to analyze the effect of GA uREDF antenatal steroids ductal and ventilatory status on CRE type ID IB DB and severity mild moderate and severe and the relation of different neonatal characteristics and event types with event duration Variations in the daily number of ID IB and DB over the 3 days of life adjusted for the effective hours of recording will be analyzed using Repeated Measures ANOVA RM-ANOVA IBM SPSS version 250 will be used for statistical analysis The significance level is set at p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None