Topics

Cardio-respiratory Events in Preterm Infants During Transition

2019-10-16 10:39:19 | BioPortfolio

Summary

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.

Description

Background Cardio-respiratory events (CRE), defined as intermittent hypoxic and/or 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 (i.e., 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 parents/legal 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 [LA:Ao] ratio <1.5), hemodynamically significant PDA (hsPDA; pulsatile shunt pattern, LA:Ao ratio ≥1.5 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 25.0, will be used for statistical analysis. The significance level is set at p<0.05.

Study Design

Conditions

Apnea of Prematurity

Intervention

pulse oximetry monitoring

Location

Sant'Orsola-Malpighi University Hospital
Bologna
Emilia-Romagna
Italy
40138

Status

Recruiting

Source

Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-16T10:39:19-0400

Clinical Trials [1649 Associated Clinical Trials listed on BioPortfolio]

Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study

Apnea of prematurity is a common condition that is usually treated with methylxanthines. Methylxanthines are adenosine receptor blockers that have powerful influences on the central nervou...

Plethysmographic and Acoustic Respiration Rate Clinical Data Collection

The objective of this clinical investigation is to collect high-resolution pulse oximetry, RRp, and RAM data in pediatric subjects for the purpose of algorithm optimization and to build a ...

Non-invasive Intervention for Apnea of Prematurity

Purpose of Study: Apnea of Prematurity (AOP) is common, affecting the majority of infants born

SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry

Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. There are two devices ...

Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis

Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome cause by different types of viruses and occurs in young children. Although bronchiolitis is a widespread and fairly co...

PubMed Articles [4849 Associated PubMed Articles listed on BioPortfolio]

Comparison of nocturnal pulse oximetry with polysomnography in children with sleep disordered breathing.

Polysomnography (PSG) is the gold standard in the diagnosis of obstructive sleep apnea (OSA). However, due to high cost and limited availability, this is difficult to access and often delayed. To eval...

Pulse oximetry screening in a midwifery-led maternity setting with high antenatal detection of congenital heart disease.

To assess local and individual factors that should be consideration in the design of a pulse oximetry screening strategy in New Zealand's midwifery-led maternity setting.

The use of oximetry and a questionnaire in primary care enables exclusion of a subsequent obstructive sleep apnea diagnosis.

The study aims to prospectively validate the prognostic value of oximetry alone or combined in a two-step strategy with a questionnaire for the exclusion of obstructive sleep apnea (OSA) in primary ca...

Characterization of respiratory compromise and the potential clinical utility of capnography in the post-anesthesia care unit: a blinded observational trial.

The utility of capnography to detect early respiratory compromise in surgical patients after anesthesia is unclear due to limited prospective data. The purpose of this trial was to determine the frequ...

Calculated arterial blood gas values from a venous sample and pulse oximetry: Clinical validation.

Arterial blood gases (ABG) are essential for assessment of patients with severe illness, but sampling is difficult in some settings and more painful than for peripheral venous blood gas (VBG). Venous ...

Medical and Biotech [MESH] Definitions

The determination of oxygen-hemoglobin saturation of blood either by withdrawing a sample and passing it through a classical photoelectric oximeter or by electrodes attached to some translucent part of the body like finger, earlobe, or skin fold. It includes non-invasive oxygen monitoring by pulse oximetry.

Monitoring of fetal heart frequency before birth in order to assess impending prematurity in relation to the pattern or intensity of antepartum UTERINE CONTRACTION.

A condition associated with multiple episodes of sleep apnea which are distinguished from obstructive sleep apnea (SLEEP APNEA, OBSTRUCTIVE) by the complete cessation of efforts to breathe. This disorder is associated with dysfunction of central nervous system centers that regulate respiration. This condition may be idiopathic (primary) or associated with lower brain stem lesions; chronic obstructive pulmonary disease (LUNG DISEASES, OBSTRUCTIVE); HEART FAILURE, CONGESTIVE; medication effect; and other conditions. Sleep maintenance is impaired, resulting in daytime hypersomnolence. Primary central sleep apnea is frequently associated with obstructive sleep apnea. When both forms are present the condition is referred to as mixed sleep apnea (see SLEEP APNEA SYNDROMES). (Adams et al., Principles of Neurology, 6th ed, p395; Neurol Clin 1996;14(3):611-28)

Disorders characterized by multiple cessations of respirations during sleep that induce partial arousals and interfere with the maintenance of sleep. Sleep apnea syndromes are divided into central (see SLEEP APNEA, CENTRAL), obstructive (see SLEEP APNEA, OBSTRUCTIVE), and mixed central-obstructive types.

An abnormal pattern of breathing characterized by alternating periods of apnea and deep, rapid breathing. The cycle begins with slow, shallow breaths that gradually increase in depth and rate and is then followed by a period of apnea. The period of apnea can last 5 to 30 seconds, then the cycle repeats every 45 seconds to 3 minutes.

More From BioPortfolio on "Cardio-respiratory Events in Preterm Infants During Transition"

Quick Search

Relevant Topics

Cardiology
Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...

Respiratory
Asthma COPD Cystic Fibrosis Pneumonia Pulmonary Medicine Respiratory Respiratory tract infections (RTIs) are any infection of the sinuses, throat, airways or lungs.  They're usually caused by viruses, but they can also ...

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...


Searches Linking to this Trial