Clinical trial NCT02159534: Primebrain Stimulation
Official title: Multicentric Prospective Randomised Single-blind Controlled Clinical Study Assessing the Effect and the Safety of Primebrain Sensorimotor Stimulation on Neurological Development of Preterm Infants (Born Before 32 Weeks' Gestation) or Infants Born Weighing Less Than 1500 g
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Infants
Lead sponsor: Queen Fabiola Children's University Hospital
Sponsor class: OTHER
First posted: 2014-06-10
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background : Brain vulnerability is particularly marked in preterm neonates and has long-term consequences. Unlike lesions affecting other organs, those that affect the brain can currently not 'be repaired' by producing new cells. However, exeprience-driven brain plasticity allows the brain to reorganise its connections to compensate (at least partially) the effects of an injury.

Purpose : To evaluate the influence of Primebrain stimulation programme administred by parents until 6 months post-term on motor and neurophysiological development of infants born \<32 weeks' gestation or with birth weight \<1500 g.

Detailed description: Preterm and very low birth weight infants are at risk for neurodevelopmental disorders, including cerebral palsy, sensory impairment and intellectual disability. Several early intervention approaches have been designed in the hope of optimising neurological development in this context. These programmes show high variety in the type of intervention, frequency of sessions and total duration of the intervention, as well as the duration of follow-up. Depending on studies, there is an inconstant benefit on cognitive and behavioural development in the first 2 years and preschool age. According to the most recent studies, it seems important that the intervention takes into account parental mental health, focuses on parent-child interactions and lasts sufficiently long.

This prospective randomized-controlled clinical study has been designed to evaluate the effects of an additional parent-administed programme to the usual care in this developmental risk population,.

The intervention is carried out at home by parents coached by physiotherapist from term-age to 6 months of corrected age. The monitoring and evaluation period for all infants participating in the study ends at 24 months of corrected age and includes clinical, neurodevelopmental, parental stress and neurophysiological assessments using high density electroencephalography and recording of event-related potentials at term age, 3, 6, 12 ,18 and 24 months of corrected age (ActiveTwo, BioSemi).

Eligibility criteria: Inclusion Criteria:

* Infants born before 32 weeks of gestation or with a birth weight less than 1500 grams

Exclusion Criteria:

* Severe congenital malformation (cerebral, cardiac or within a syndrome)
* Neurodevelopmental genetic syndrome
* Cytomegalovirus, rubella or toxoplasmosis congenital infection
* Neonatal hypothyroidism
* Peripheral neurological disorder or congenital muscular disorder
* Neurodegenerative disorder

Primary outcomes:
measure: Motor development using Bayley Scales of Infant Development (BSID-III)
timeFrame: at 24 months of corrected age.
Secondary outcomes:
measure: Language and cognitive development using Bayley Scales of Infant Development (BSID-III)
timeFrame: at 6, 12, 18 and 24 months of corrected age
measure: Parental Stress Index (PSI), short form
timeFrame: at 6, 12,18 and 24 months of corrected age.
Other outcomes:
measure: high-density electroencephalography recording
timeFrame: at age-term, 3, 6, 12,18 and 24 months of corrected age
Locations:
city: Brussels
country: Belgium
facility: Queen Fabiola Children's University Hospital
Study officials:
References:
citation: Vohr BR, Wright LL, Poole WK, McDonald SA. Neurodevelopmental outcomes of extremely low birth weight infants <32 weeks' gestation between 1993 and 1998. Pediatrics. 2005 Sep;116(3):635-43. doi: 10.1542/peds.2004-2247.
citation: Spittle AJ, Spencer-Smith MM, Eeles AL, Lee KJ, Lorefice LE, Anderson PJ, Doyle LW. Does the Bayley-III Motor Scale at 2 years predict motor outcome at 4 years in very preterm children? Dev Med Child Neurol. 2013 May;55(5):448-52. doi: 10.1111/dmcn.12049. Epub 2012 Dec 6.
citation: Linsell L, Malouf R, Morris J, Kurinczuk JJ, Marlow N. Prognostic Factors for Poor Cognitive Development in Children Born Very Preterm or With Very Low Birth Weight: A Systematic Review. JAMA Pediatr. 2015 Dec;169(12):1162-72. doi: 10.1001/jamapediatrics.2015.2175.
citation: Linsell L, Malouf R, Morris J, Kurinczuk JJ, Marlow N. Prognostic factors for cerebral palsy and motor impairment in children born very preterm or very low birthweight: a systematic review. Dev Med Child Neurol. 2016 Jun;58(6):554-69. doi: 10.1111/dmcn.12972. Epub 2016 Feb 10.
citation: Linsell L, Malouf R, Johnson S, Morris J, Kurinczuk JJ, Marlow N. Prognostic Factors for Behavioral Problems and Psychiatric Disorders in Children Born Very Preterm or Very Low Birth Weight: A Systematic Review. J Dev Behav Pediatr. 2016 Jan;37(1):88-102. doi: 10.1097/DBP.0000000000000238.
citation: Hadders-Algra M. Early brain damage and the development of motor behavior in children: clues for therapeutic intervention? Neural Plast. 2001;8(1-2):31-49. doi: 10.1155/NP.2001.31.
citation: Ismail FY, Fatemi A, Johnston MV. Cerebral plasticity: Windows of opportunity in the developing brain. Eur J Paediatr Neurol. 2017 Jan;21(1):23-48. doi: 10.1016/j.ejpn.2016.07.007. Epub 2016 Aug 9.
citation: 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.
citation: Musacchia G, Ortiz-Mantilla S, Realpe-Bonilla T, Roesler CP, Benasich AA. Infant Auditory Processing and Event-related Brain Oscillations. J Vis Exp. 2015 Jul 1;(101):e52420. doi: 10.3791/52420.
citation: Friel KM, Chakrabarty S, Martin JH. Pathophysiological mechanisms of impaired limb use and repair strategies for motor systems after unilateral injury of the developing brain. Dev Med Child Neurol. 2013 Nov;55 Suppl 4:27-31. doi: 10.1111/dmcn.12303.
citation: Engle WA; American Academy of Pediatrics Committee on Fetus and Newborn. Age terminology during the perinatal period. Pediatrics. 2004 Nov;114(5):1362-4. doi: 10.1542/peds.2004-1915.
citation: Pelc K, Daniel I, Wenderickx B, Dan B; Primebrain group. Multicentre prospective randomised single-blind controlled study protocol of the effect of an additional parent-administered sensorimotor stimulation on neurological development of preterm infants: Primebrain. BMJ Open. 2017 Dec 3;7(12):e018084. doi: 10.1136/bmjopen-2017-018084.