Preterm Birth Clinical Trial
Official title:
Cardiovascular and Cerebrovascular Responses to Cardio-respiratory Events in Very Preterm Infants During the Transitional Period
NCT number | NCT04184245 |
Other study ID # | SO-CRE-2 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 22, 2018 |
Est. completion date | January 3, 2020 |
Intermittent episodes of hypoxemia and/or bradycardia, also defined as cardio-respiratory events (CRE) are very frequent in preterm infants and may result in transient hypoxia and hypoperfusion of target organs, with possible clinical implications. The hemodynamic instability that characterizes the first 72 hours of life, also called as transitional period, place preterm infants at high risk of complications and may contribute to enhance fluctuations in end-organ perfusion and oxygenation induced by CRE. In this study we aimed to explore cardiovascular and cerebrovascular changes determined by different CRE types in preterm infants during the transitional period.
Status | Completed |
Enrollment | 42 |
Est. completion date | January 3, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 3 Days |
Eligibility |
Inclusion Criteria: - gestational age <32 weeks' gestation AND/OR birth weight <1500 g Exclusion Criteria: - major congenital malformations - congenital heart disease - mechanical ventilation |
Country | Name | City | State |
---|---|---|---|
Italy | S. Orsola-Malpighi University Hospital | Bologna | Emilia-Romagna |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Increase/reduction of cTOI during isolated desaturation, isolated bradycardia and desaturation-bradycardia | Comparison of percentage cTOI changes (cTOI at baseline/during the event) among isolated desaturation, isolated bradycardia and desaturation-bradycardia | 0-72 hours of life | |
Primary | Increase/reduction of cFTOE during isolated desaturation, isolated bradycardia and desaturation-bradycardia | Comparison of percentage cFTOE changes (baseline/during the event) among isolated desaturation, isolated bradycardia and desaturation-bradycardia | 0-72 hours of life | |
Primary | Increase/reduction of cTHI during isolated desaturation, isolated bradycardia and desaturation-bradycardia | Comparison of percentage cTHI changes (baseline/during the event) among isolated desaturation, isolated bradycardia and desaturation-bradycardia | 0-72 hours of life | |
Primary | Increase/reduction of CO during isolated desaturation, isolated bradycardia and desaturation-bradycardia | Comparison of percentage CO changes (CO at baseline/during the event) among isolated desaturation, isolated bradycardia and desaturation-bradycardia | 0-72 hours of life72 hours | |
Primary | Increase/reduction of SV during isolated desaturation, isolated bradycardia and desaturation-bradycardia | Comparison of percentage SV changes (baseline/during the event) among isolated desaturation, isolated bradycardia and desaturation-bradycardia | 0-72 hours of life | |
Primary | Increase/reduction of ICON during isolated desaturation, isolated bradycardia and desaturation-bradycardia | Comparison of percentage ICON changes (baseline/during the event) among isolated desaturation, isolated bradycardia and desaturation-bradycardia | 0-72 hours of life | |
Primary | Increase/reduction of SVR during isolated desaturation, isolated bradycardia and desaturation-bradycardia | Comparison of percentage SVR changes (baseline/during the event) among isolated desaturation, isolated bradycardia and desaturation-bradycardia | 0-72 hours of life | |
Secondary | Effect of neonatal characteristics on cerebrovascular parameters | Generalized estimating equation (GEE) analysis evaluating the effect of clinical variables (e.g., GA, uREDF, antenatal steroids, ductal and ventilatory status etc.) on percentage changes of cTOI, cFTOE, cTHI. | 0-72 hours of life | |
Secondary | Effect of neonatal characteristics on cardiovascular parameters | Generalized estimating equation (GEE) analysis evaluating the effect of clinical variables (e.g., GA, uREDF, antenatal steroids, ductal and ventilatory status etc.) on percentage changes of CO, SV, ICON, SVR | 0-72 hours of life |
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