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Effect of the IBAIP in Preterm Infants Neurodevelopment

Study acronym: IBAIP
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Site details revised at 3 of 9 sites
    • Eligibility criteria expanded, about 1 word
    v8
  2. Minor Interventions: Ages and Stages Questionnaire (ASQ) (Other), Bayley Scales of Infant and Toddler Development (BSID-III) (Other), IBAIP : Infant Behaviour… to Ages and Stages Questionnaire (ASQ) (Other), Bayley Scales of Infant and Toddler Development (BSID-IV) (Other), IBAIP : Infant Behaviour…v7 Show 4 more changesShow less
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints revised (3)
    • Site contacts updated at 1 of 9 sites
    • Study description expanded, about 3 words
  3. Minor Site details revised at 2 of 9 sitesv6
  4. Notable Primary and study completion dates: Jan 8, 2026 to Jan 8, 2028
    • Study sites: 8 to 9
    v5
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 30, 2022 to Nov 8, 2022
    • Study sites: 7 to 8
    • Primary and study completion dates: Aug 30, 2025 to Jan 8, 2026
    v4
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  1. Notable Primary and study completion dates: Jun 30, 2024 to Aug 30, 2025
    • Start date: Apr 30, 2021 to Jun 30, 2022
    v3
  2. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04685356
Lead Sponsor University Hospital, Brest
Conditions
(from sponsor)
Premature Birth
Related terms Premature Birth
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov