Cardio-respiratory Events in Preterm Infants During Transition

NCT04123691 | Completed

• 1 other identifier: SO-CRE-1
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Apnea of Prematurity; Apneic Spells of Newborn Nos; Patent Ductus Arteriosus; Premature Birth; Desaturation of Blood; Bradycardia Neonatal

Keywords

cardio-respiratory events; preterm infants; transitional period; desaturation; bradycardia; apnea

Outcome Measures

Primary Outcomes (4)

• Definition of CRE characteristics

  Total number of desaturations, bradycardias and combined events

  0-72 hours of life

• Time distribution of CRE

  Daily incidence of desaturations, bradycardias and combined events

  0-72 hours of life

• Effect of neonatal characteristics on CRE type

  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.

  0-72 hours of life

• Effect of neonatal characteristics on CRE severity

  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.

  0-72 hours of life

Interventions

pulse oximetry monitoring DEVICE

pulse oximetry monitoring as per routine clinical practice

Eligibility Criteria

• Age: 1 Hour - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm newborns age 0 to 72 hours of life with non-invasive ventilatory support.

You may qualify if:

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

You may not qualify if:

• mechanical ventilation
• major congenital malformations
• genetic abnormalities

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

Apnea; Ductus Arteriosus, Patent; Premature Birth; Bradycardia

Condition Hierarchy (Ancestors)

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

Study Officials

• Silvia Martini, MD

  Sant'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: PhD student

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 11, 2019
• Study Start: February 21, 2018
• Primary Completion: August 31, 2019
• Study Completion: September 2, 2019
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)