NCT02159534

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

5.4 years

First QC Date

June 6, 2014

Last Update Submit

February 11, 2019

Conditions

Preterm Infants

Outcome Measures

Primary Outcomes (1)

  • Motor development using Bayley Scales of Infant Development (BSID-III)

    at 24 months of corrected age.

Secondary Outcomes (2)

  • 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.

Other Outcomes (1)

  • high-density electroencephalography recording

    at age-term, 3, 6, 12,18 and 24 months of corrected age

Study Arms (2)

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 ").

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 ").

Other: Primebrain

Interventions

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.

Primebrainusual care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Fabiola Children's University Hospital

Brussels, Belgium

Location

Related Publications (12)

  • 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.

    PMID: 16143580BACKGROUND

  • 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.

    PMID: 23216518BACKGROUND

  • 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.

    PMID: 26457641BACKGROUND

  • 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.

    PMID: 26862030BACKGROUND

  • 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.

    PMID: 26703327BACKGROUND

  • 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.

    PMID: 11530887BACKGROUND

  • 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.

    PMID: 27567276BACKGROUND

  • 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: 26597166BACKGROUND

  • 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.

    PMID: 26167670BACKGROUND

  • 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.

    PMID: 24237276BACKGROUND

  • 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.

    PMID: 15520122BACKGROUND

  • 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.

    PMID: 29203503DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2014

First Posted

June 10, 2014

Study Start

September 1, 2014

Primary Completion

February 1, 2020

Study Completion

September 1, 2020

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

BE(1)