Primebrain Stimulation

February 11, 2019 updated by: Queen Fabiola Children's University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Queen Fabiola Children's University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primebrain

' 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
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.
Other: usual care
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
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
high-density electroencephalography recording
Time Frame: at age-term, 3, 6, 12,18 and 24 months of corrected age
Exploratory outcome, evaluation of neurophysiological maturation
at age-term, 3, 6, 12,18 and 24 months of corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Fabiola Children's University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

June 6, 2014

First Submitted That Met QC Criteria

June 9, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HU15/neuro/primebrain

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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