Preterm InfantsNCT02159534
Primebrain Stimulation
A study testing Primebrain in people with Preterm Infants, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterm Infants
- What is being tested?
- Primebrain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2014to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants born before 32 weeks of gestation or with a birth weight less than 1500 grams
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Preterm Infants
- Being tested
- Primebrain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrimebrainOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Primebrain | Experimental | ' 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 "). Receives: Other: Primebrain |
| usual care | Other | Infants in the comparison group receive usual care for preterm and infants born with low birth weight as organized in Belgium (" INAMI convention "). Receives: Other: Primebrain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor development using Bayley Scales of Infant Development (BSID-III)
Measured: at 24 months of corrected age.
Secondary outcomes (2)
Language and cognitive development using Bayley Scales of Infant Development (BSID-III)
Measured: at 6, 12, 18 and 24 months of corrected age
Parental Stress Index (PSI), short form
Measured: at 6, 12,18 and 24 months of corrected age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159534
- Sponsor's protocol ID
- HU15/neuro/primebrain
- Status last verified
- Feb 2019
- First submitted
- 6 Jun 2014
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16143580Spittle 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.
PubMed 23216518Linsell 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.
PubMed 26457641Linsell 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.
PubMed 26862030Linsell 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.
PubMed 26703327Hadders-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.
PubMed 11530887Ismail 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.
PubMed 27567276Spittle 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.
PubMed 26597166Musacchia 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.
PubMed 26167670Friel 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.
PubMed 24237276Engle 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.
PubMed 15520122Pelc 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.
PubMed 29203503
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02159534
- Acronym / sponsor ID
- HU15/neuro/primebrain
- Conditions
- Preterm Infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Queen Fabiola Children's University HospitalUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primebrain | Experimental | Other: 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 "). |
| usual care | Other | Other: PrimebrainInfants in the comparison group receive usual care for preterm and infants born with low birth weight as organized in Belgium (" INAMI convention "). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Infants born before 32 weeks of gestation or with a birth weight less than 1500 grams
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrimebrainPrimebrain 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 | Primebrain, usual care |
Primary outcome
Motor development using Bayley Scales of Infant Development (BSID-III)
Time frame: at 24 months of corrected age.
2 secondary outcomes
Language and cognitive development using Bayley Scales of Infant Development (BSID-III)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Background: PubMed 16143580Vohr 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.
- Background: PubMed 23216518Spittle 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.
- Background: PubMed 26457641Linsell 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.
- Background: PubMed 26862030Linsell 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.
- Background: PubMed 26703327Linsell 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.
- Background: PubMed 11530887Hadders-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.
- Background: PubMed 27567276Ismail 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.
- Background: PubMed 26597166Spittle 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.
- Background: PubMed 26167670Musacchia 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.
- Background: PubMed 24237276Friel 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.
- Background: PubMed 15520122Engle 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.
- Derived from this study: PubMed 29203503Pelc 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primebrain in people with Preterm Infants, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor development using Bayley Scales of Infant Development (BSID-III) (time frame: at 24 months of corrected age.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02159534, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.