MedTrace Logo

Cardio-respiratory Events in Preterm Infants During Transition

NCT04123691 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2019-11-26

No results posted yet for this study

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

Interventions

DEVICE

pulse oximetry monitoring

pulse oximetry monitoring as per routine clinical practice

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Silvia Martini, MD · Sant'Orsola-Malpighi University Hospital, Bologna, Italy

Eligibility

Min Age
1 Hour
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-21
Primary Completion
2019-08-31
Completion
2019-09-02

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04123691 on ClinicalTrials.gov