Hemodynamic Responses to Cardio-respiratory Events in Preterm Infants

NCT04184245 | Completed

• 1 other identifier: SO-CRE-2
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Apnea of Prematurity; Preterm Birth; Patent Ductus Arteriosus; Hypoxia, Brain; Cardiac Output, Low; Bradycardia Neonatal; Hypoxia Neonatal

Keywords

preterm infants; hypoxic episodes; non-invasive cardiac output monitoring; near infrared spectroscopy; cardiac output; cerebral oxygenation; bradycardia; cardiorespiratory events

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Effect of neonatal characteristics on cerebrovascular parameters

  0-72 hours of life

• Effect of neonatal characteristics on cardiovascular parameters

  0-72 hours of life

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants on spontaneous breathing during the transitional period (0-72 hours of life).

You may qualify if:

• gestational age \<32 weeks' gestation AND/OR birth weight \<1500 g

You may not qualify if:

• major congenital malformations
• congenital heart disease
• mechanical ventilation

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

S. Orsola-Malpighi University Hospital

Bologna, Emilia-Romagna, 40138, Italy

Location

MeSH Terms

Conditions

Apnea; Premature Birth; Ductus Arteriosus, Patent; Hypoxia, Brain; Cardiac Output, Low; Asphyxia Neonatorum; Bradycardia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia; Infant, Newborn, Diseases; Arrhythmias, Cardiac; Pathologic Processes

Study Officials

• Luigi Corvaglia, MD

  S. Orsola-Malpighi University Hospital, Bologna, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Neonatal Consultant

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 3, 2019
• Study Start: February 22, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 3, 2020
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)