Correlation Between Cerebral Oxygenation and Neurodevelopment in VLBW Preterm Infants.

NCT03104296 | Completed

• 3 other identifiers: SO-2016-GQPRET_01_13NIRS-SO
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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).

Conditions

Psychomotor Impairment

Keywords

NIRS; Griffiths Mental Development Scales; prematurity

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Griffiths Mental Development Scales DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 15 Days - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants admitted to the Neonatal Intensive Care Unit (NICU) of St. Orsola-Malpighi Hospital, Bologna (Italy) fulfilling the eligibility criteria.

You may qualify if:

• gestational age \<32 weeks
• birth weight \<1500 g.

You may not qualify if:

• congenital abnormalities
• hypoxic-ischemic encephalopathy
• intraventricular haemorrhage grade 3-4
• post-haemorrhagic ventricular dilatation
• periventricular leukomalacia and/or porencephalic cysts
• general anaesthesia

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

U.O. Neonatologia, Day Hospital

Bologna, BO, 40138, Italy

Location

Related Publications (6)

• 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.

  PMID: 27046108 BACKGROUND

• 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.

  PMID: 24794920 BACKGROUND

• 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.

  PMID: 24630591 BACKGROUND

• 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.

  PMID: 26597166 BACKGROUND

• 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.

  PMID: 23219333 BACKGROUND

• 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.

  PMID: 25382744 BACKGROUND

MeSH Terms

Conditions

Psychomotor Disorders; Premature Birth

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

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: April 3, 2017
• First Posted: April 7, 2017
• Study Start: November 1, 2013
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: April 7, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)