Correlation Between Neonatal Cerebral Oxygenation and Later Psychomotor Outcome in Very-low-birth-weight Preterm Infants.
Sponsor study identifier
Secondary identifiers
OTHER · Ethic Committee of St. Orsola-Malpighi University Hospital
OTHER · Ethic Committee of St. Orsola-Malpighi University Hospital
observational
63
1 country
1
Study Start
November 1, 2013
Actual (reported)Primary Completion
December 31, 2016
Actual (reported)Study Completion
December 31, 2016
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2013
Actual (reported)December 31, 2016
Actual (reported)December 31, 2016
Actual (reported)April 3, 2017
Actual (reported)April 7, 2017
Actual (reported)Psychomotor outcome
Psychomotor outcome is assessed by Griffiths Mental Development Scales 0-2 years. Psychomotor outcome is considered normal if DQ\>88.6; lower values characterize psychomotor impairment, which is further defined as mild (-1 to -2 SD, corresponding to 88.6-76.9 DQ), moderate (-2 to -3 SD, corresponding to 76.8- 65.1 DQ) and severe (\<-3 SD, corresponding to 65 DQ).
24 months
Griffiths Mental Development Scales investigate 5 main areas (locomotor, personal and social skills, hearing and language, eye and hand coordination, performance), providing a general developmental quotient (DQ) of infant's abilities and five sub-scale quotients (SQ) for each developmental area. The assessments are performed individually in a quiet room, over a 45-min period, by the same professional trained psychologist for the whole study period and are implemented in the presence of the infant's parent. The obtained results are adjusted for corrected age, in order to consider the neurobiological maturation of the enrolled infants.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Preterm infants admitted to the Neonatal Intensive Care Unit (NICU) of St. Orsola-Malpighi Hospital, Bologna (Italy) fulfilling the eligibility criteria.
U.O. Neonatologia, Day Hospital
Bologna, BO, 40138, Italy
Thompson DK, Chen J, Beare R, Adamson CL, Ellis R, Ahmadzai ZM, Kelly CE, Lee KJ, Zalesky A, Yang JYM, Hunt RW, Cheong JLY, Inder TE, Doyle LW, Seal ML, Anderson PJ. Structural connectivity relates to perinatal factors and functional impairment at 7years in children born very preterm. Neuroimage. 2016 Jul 1;134:328-337. doi: 10.1016/j.neuroimage.2016.03.070. Epub 2016 Apr 1.
Fischi-Gomez E, Vasung L, Meskaldji DE, Lazeyras F, Borradori-Tolsa C, Hagmann P, Barisnikov K, Thiran JP, Huppi PS. Structural Brain Connectivity in School-Age Preterm Infants Provides Evidence for Impaired Networks Relevant for Higher Order Cognitive Skills and Social Cognition. Cereb Cortex. 2015 Sep;25(9):2793-805. doi: 10.1093/cercor/bhu073. Epub 2014 May 2.
63 participants (actual enrollment reported by the registry).
First Submitted
April 3, 2017
First Posted
April 7, 2017
Study Start
November 1, 2013
Actual (reported)High Confusion: Cannabis & Driving
Contact the study team to confirm eligibility.
Sansavini A, Pentimonti J, Justice L, Guarini A, Savini S, Alessandroni R, Faldella G. Language, motor and cognitive development of extremely preterm children: modeling individual growth trajectories over the first three years of life. J Commun Disord. 2014 May-Jun;49:55-68. doi: 10.1016/j.jcomdis.2014.02.005. Epub 2014 Feb 22.
Spittle A, Orton J, Anderson PJ, Boyd R, Doyle LW. Early developmental intervention programmes provided post hospital discharge to prevent motor and cognitive impairment in preterm infants. Cochrane Database Syst Rev. 2015 Nov 24;2015(11):CD005495. doi: 10.1002/14651858.CD005495.pub4.
Sood ED, Benzaquen JS, Davies RR, Woodford E, Pizarro C. Predictive value of perioperative near-infrared spectroscopy for neurodevelopmental outcomes after cardiac surgery in infancy. J Thorac Cardiovasc Surg. 2013 Feb;145(2):438-445.e1; discussion 444-5. doi: 10.1016/j.jtcvs.2012.10.033. Epub 2012 Dec 6.
Verhagen EA, Van Braeckel KN, van der Veere CN, Groen H, Dijk PH, Hulzebos CV, Bos AF. Cerebral oxygenation is associated with neurodevelopmental outcome of preterm children at age 2 to 3 years. Dev Med Child Neurol. 2015 May;57(5):449-55. doi: 10.1111/dmcn.12622. Epub 2014 Nov 8.
Primary Completion
December 31, 2016
Actual (reported)Study Completion
December 31, 2016
Actual (reported)Last Updated
April 7, 2017
Record last verified: 2017-04
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