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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
Sponsor:
Information provided by (Responsible Party):
Silvia Martini, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Brief 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.


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

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: pulse oximetry monitoring
    pulse oximetry monitoring as per routine clinical practice


Primary Outcome Measures :
  1. Definition of CRE characteristics [ Time Frame: 0-72 hours of life ]
    Total number of desaturations, bradycardias and combined events

  2. Time distribution of CRE [ Time Frame: 0-72 hours of life ]
    Daily incidence of desaturations, bradycardias and combined events

  3. 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.

  4. 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.



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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Preterm newborns age 0 to 72 hours of life with non-invasive ventilatory support.
Criteria

Inclusion Criteria:

- gestational age <32 weeks and/or birth weight <1500 g

Exclusion Criteria:

  • mechanical ventilation
  • major congenital malformations
  • genetic abnormalities

Information from the National Library of Medicine

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


Contacts
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Contact: Silvia Martini, MD 0039 051 214774 silvia.martini9@unibo.it
Contact: Luigi Corvaglia, Prof 0039 051 214774 luigi.corvaglia@unibo.it

Locations
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Italy
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      
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
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Principal Investigator: Silvia Martini, MD Sant'Orsola-Malpighi University Hospital, Bologna, Italy

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Responsible Party: Silvia Martini, PhD student, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT04123691     History of Changes
Other Study ID Numbers: SO-CRE-1
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Silvia Martini, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
cardio-respiratory events
preterm infants
transitional period
desaturation
bradycardia
apnea
Additional relevant MeSH terms:
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Premature Birth
Bradycardia
Ductus Arteriosus, Patent
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities