Transitional Cerebrovascular Reactivity in Very Preterm Infants

NCT04423016 | Completed

• 1 other identifier: NEO-TOHRx
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The transitional period, defined as the first 72 hours after preterm birth, is often characterized by a significant hemodynamic instability and may also be associated with an impairment of cerebral autoregulation, with relevant clinical implications. The moving correlation coefficient between cerebral oxygenation and heart rate, also defined as TOHRx, has been previously proposed as a marker of cerebrovascular reactivity and provides an indirect estimation of cerebral autoregulation in preterm infants. This study aims to evaluate whether different antenatal, perinatal and postnatal factors may influence cerebrovascular reactivity in very preterm infants during the transitional period.

Conditions

Cerebral Autoregulation; Preterm Birth; Premature Infant Disease

Keywords

cerebral autoregulation; cerebrovascular reactivity; preterm infants; transitional period

Outcome Measures

Primary Outcomes (6)

• Correlation between TOHRx and gestational age

  Correlation between TOHRx and gestational age

  0-72 hours

• Correlation between TOHRx and antenatal steroids administration

  Correlation between TOHRx and antenatal steroids administration (full course vs. incomplete course or not given)

  0-72 hours

• Correlation between TOHRx and antenatal Doppler status

  Correlation between TOHRx and antenatal Doppler status (normal or abnormal)

  0-72 hours

• Correlation between TOHRx and ductal status

  Correlation between TOHRx and ductal status (hemodynamically significant, restrictive or closed)

  0-72 hours

• Correlation between TOHRx and respiratory support

  Correlation between TOHRx and respiratory support modality (mechanical ventilation, CPAP, nasal cannulas or self-ventilating in air)

  0-72 hours

• Correlation between TOHRx and inotropes

  Correlation between TOHRx and inotropes administration (dopamine; dobutamine; dopamine and dobutamine)

  0-72 hours

Interventions

Near Infrared Spectroscopy monitoring DEVICE

Non-invasive continuous monitoring of cerebral oxygenation

Electrical velocimetry and pulse oximetry DEVICE

Non-invasive continuous monitoring of cerebral oxygenation

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants \<32 weeks' gestation during the transitional period (0-72 hours of life)

You may qualify if:

• gestational age \<32 weeks' gestation

You may not qualify if:

• major congenital malformations
• congenital heart disease

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Sant'Orsola-Malpighi University Hospital

Bologna, Emilia-Romagna, 40138, Italy

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Oximetry

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

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

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: February 21, 2018
• Primary Completion: June 30, 2021
• Study Completion: July 3, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)