Clinical Trial: Correlation Between Cerebral Oxygenation and Neurodevelopment in VLBW Preterm Infants.

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Correlation Between Neonatal Cerebral Oxygenation and Later Psychomotor Outcome in Very-low-birth-weight Preterm Infants.

Brief Summary:

The recent improvements in neonatal intensive care have led to a substantial increase in the survival rate of preterm infants; nevertheless, this population is still at high risk for long-term neurodevelopmental disabilities. Significant anatomical changes in brain structures and abnormal patterns of neuronal myelination and brain connectivity have been associated with preterm birth, with possible long-term effects on cognitive, motor and social skills.

The validation of clinical tools able to predict neurodevelopmental outcomes in the preterm population might help at identifying infants at greatest risk of impairment, who would benefit most from early supportive interventions exploiting brain neuroplasticity.

Near infrared reflected spectroscopy (NIRS) provides a bedside, non-invasive, continuous monitoring of cerebral oxygen saturation (CrSO2), which has been proposed as a predictive marker for later neurodevelopment in neonates undergone cardiac surgery; to date, however, evidence on the correlation between CrSO2 and later neurodevelopment in preterm infants is almost lacking.

This study aims to evaluate whether CrSO2 monitoring, performed before NICU discharge in clinically stable very low birth weight (VLBW) preterm infants, can predict psychomotor outcomes during the first 24 months of corrected age (ca).

Detailed Summary:

The improvements in neonatal intensive care occurred over the last decades have led to a substantial increase in the survival rate of preterm infants, especially of extremely low birth weight. Nevertheless, the delicate maturation of central nervous system (CNS) in the extrauterine environment, together with the possible development of prematurity-related clinical complications that could result in brain injury, place this population at high risk for long-term neurodevelopmental disabilities.

Significant anatomical changes in brain structures have been associated with preterm birth; among these, enlarged ventricles and subarachnoid spaces, reduced subcortical white matter and decreased cortical and deep nuclear grey matter are the most common. Additionally, there is increasing evidence of abnormal patterns of neuronal myelination and brain connectivity in preterm infants, with possible concerning long-term effects on language, motor and social skills. As for cognitive abilities, a direct correlation with gestational age (GA) has been previously shown in a large cohort of preterm born children at school age.

In its early phases, the developmental of CNS is characterized by an intrinsic neuroplasticity, according which repeated experiences could influence the arrangement of synaptic connections and neural circuitries, thus resulting in structural and functional changes. By exploiting this feature, an early establishment of supportive interventions¬ might aid to compensate the anatomical and functional constraints connected to preterm birth and to improve preterm infants' neurodevelopment.

The validation of clinical tools able to predict neurodevelopmental outcomes in the preterm population might help at identifying infants at greatest risk of impairment, who would benefi
Sponsor: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Current Primary Outcome: Psychomotor outcome [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Dates:
Date Received: April 3, 2017
Date Started: November 1, 2013
Date Completion:
Last Updated: April 3, 2017
Last Verified: April 2017