Primebrain Stimulation

Study Overview
=================
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).

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

Conditions
-----------------
Preterm Infants

Intervention / Treatment
-----------------
* Other: Primebrain


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primebrain<br>' Stimulation ' Infants group will receive Primebrain stimulation whose items were selected according to a Delphi process and discussed at the European Academy of Childhood Disability (2013). This sensorimotor stimulation programme is administered at home by parents (trained and monitored by a physical therapist), once a day between term-age and 6 months of corrected age. In addition, these infants undergo systematic monitoring for preterm and infants born with low birth weight as organized in Belgium ( INAMI convention ). | Other: Primebrain<br>* Primebrain stimulation programme aims to facilitate the infant's self-organization of postural competences by proposing varied sensorimotor experiences in a context supporting parent-child interaction.<br>|
| Other: usual care<br>Infants in the comparison group receive usual care for preterm and infants born with low birth weight as organized in Belgium ( INAMI convention ). | Other: Primebrain<br>* Primebrain stimulation programme aims to facilitate the infant's self-organization of postural competences by proposing varied sensorimotor experiences in a context supporting parent-child interaction.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor development using Bayley Scales of Infant Development (BSID-III) |  | at 24 months of corrected age. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Language and cognitive development using Bayley Scales of Infant Development (BSID-III) |  | at 6, 12, 18 and 24 months of corrected age | 
| Parental Stress Index (PSI), short form |  | at 6, 12,18 and 24 months of corrected age. |