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Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interactions and Social Cognition in Very Premature Children

Study acronym: CALIN
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv9
  2. Primary completion date: Jan 19, 2025 to Jan 19, 2027
    • Study completion date: Jan 19, 2032 to Jan 19, 2033
    v8
  3. Re-verified, no change to tracked fieldsv7
  4. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Primary completion date: Sep 2023 to Jan 19, 2025
    • Study completion date: Sep 2028 to Jan 19, 2032
    • Start date changed from estimate of Oct 2022 to Jan 19, 2023
    • Site details revised
  5. Start date: Mar 2022 to Oct 2022v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Sep 2021 to Mar 2022v4
  2. Start date: Sep 2020 to Sep 2021v3
  3. Re-verified, no change to tracked fieldsv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
CHU de Reims
79 trials monitored
See 2 trials at risk
Attachment is built primarily on the first interactions of the first 9 months of a baby's life. These first interactions and their effects of stress, pleasure and displeasure are retained to establish some of the baby's attachment behaviours and future relationships with others. Extreme prematurity strongly modify these first interactions between parents and child. Very preterm child is separated from his parents and is placed in a stressful, technical and potentially painful environment. Early interventions stimulate neuroplasticity and can positively affect the neurological development of very preterm infant. Tactile stimuli such as skin-to-skin contact and massages carried out by parents can be pleasant experiences that can support early interactions between parents and child.
Trial Details
NCT Number NCT04380051
Lead Sponsor CHU de Reims
Conditions
(from sponsor)		 Very Preterm Birth
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov