Effect of the IBAIP in Preterm Infants Neurodevelopment
ConditionPremature Birth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-32
SponsorUniversity Hospital, Brest
About this trial
Mortality in very preterm infants has decreased significantly over the past twenty years. However, neuromotor, behavioral and cognitive development disorders are more common in these children born before 33 weeks of gestation as compared to term born infants.
These neurodevelopmental disorders include difficulties with self-regulation, tone, posture or poor quality movements as well as inadequate responses to sensory simulation.
Post-hospital discharge follow-up and interventionsof children born very preterm ares very heterogeneous in France. They are mainly carried out in a rehabilitation center, based on caregivers whereas IBAIP is carried out at home and family centered.
Early interventions during hospitalization or after discharge appear potentially of great interest in improving the neurodevelopemental outcome of the very preterm infants. Several early interventions have been developed and evaluated in other countries. These interventions are designed to be used early in life, mainly during the first 3 years of life, and are based on brain plasticity and intense synaptogenesis during this period of life.
The IBAIP (Infant Behavior Assessment and Intervention Program) was developed on the same theoretical foundations as the NIDCAP (Neonatal Individualized Development Care and Assessment Program). IBAIP consists of providing the child and his family with an intervention, at home, starting just before hospital discharge up to a 6 months corrected age. .The aim of IBAIP is to support developmental functions including infant's self-regulation and focus on improving the responsiveness of parents' infant interactions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Preterm infants born (including multiple pregnancies) at a gestational age between 25 weeks +0 days and 32 weeks + 6days.
Written informed consent of at least one of the parents / legal guardian or 2 parents / legal guardians depending on the family context
Normal neurological examination between 36 and 41 weeks of corrected age
Disqualifiers
Intraventricular hemorrhage (III or IV), periventricular leukomalacia
Brain MRI abnormalities performed after 36 weeks of corrected age
Life-threatening pathology
Severe congenital abnomality
Trial design
Design model
Parallel
Treatments tested in this trial
IBAIP : Infant Behaviour Assessment and Intervention Program
Other interventionThe IBAIP intervention program consists of providing an intervention with the child and their family, at home, upon discharge from hospital and up to a corrected age of 6 months. Interventions therefore take place at the early stage of the child's brain development. The intervention is performed by a IBAIP-trained and certified physiotherapist or psychomotor therapist trained , at the rate of one session per month over a period of approximately 6 to 8 months (6 months of corrected age). The session takes place in the child's usual living environment, at home, in the presence of at least one of the parents. It focuses on the child's behaviors and consists of assisting the family in its interactions with the child so that these are adapted and responsive to the child's development needs over time through repeated interventions.
Standard Support
Other interventionOne medical consultation per month and, if indicated by the physician providing follow-up, medical specialist and / or paramedical (physiotherapy, speech therapy, psychomotricity, etc.) consultations including interventions in the case of developmental delays
Ages and Stages Questionnaire (ASQ)
Other interventionGlobal development screening tool
Parenting Stress Index (PSI)
Other interventionIndex used to detect difficulties sufficiently significant that they might require psychosocial intervention
Bayley Scales of Infant and Toddler Development (BSID-IV)
Other interventionThis test was designed to measure the development of infants / young children. This assessment examines all spheres of child development, identifies children with developmental delay and assesses children's developmental performance compared to their peers.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: IBAIP GroupExperimental treatment 4 interventions
Group B: Control groupActive comparator 4 interventions
Trial outcomes
Primary outcomes
1
To assess the effect of the Infant Behavior Assessment and Intervention Program Program (IBAIP) in very preterm infants (< 33 weeks of gestation) on neurodevelopment at the corrected age of 2 years
Patient neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development (BSID-IV) scale. This test studies the different notions of development: cognitive, language, motor skills, socio-emotional, behavioral, communication and autonomy.
Time frame
2 years of corrected ageSecondary outcomes
1
To assess the effect of IBAIP on the 5 sub-scores of BSID-IV: cognitive, language, motor, socio-emotional and behavioral adaptive
The BSID-IV scale can be analyzed at the level of each of these subscales. The different scores obtained allow us to identify precisely at what level the effect on neurodevelopment was the most significant.
Time frame
2 years of corrected age2
To assess the effect on the stress level of mothers and fathers
To assess through the response to the Parental Stress Index. This questionnaire consists in 120 items using a 5-level Likert scale. It allows the assessment of life stress score, parental stress and child stress.
Time frame
2 years of corrected age3
Parental assessment of psychomotor development
Ages and Stages questionnaire completed by the parents to assess the child's neurodevelopment in 5 areas (fine motor skills, gross motor skills, communication, problem solving, individual or social skills).
Time frame
2 years of corrected ageSponsors and contacts
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Source ClinicalTrials.gov