Clinical Trials Logo

Clinical Trial Summary

Our current reflexion is that sensory dys-stimulations, including vestibule-proprioceptive disorders and unbalanced between brain and brainstem maturation of the neonatal period involve an early deviant development for immature infants that will be cascaded through the brain scaffolding and later development. The primary purpose is to determine whether the Early Psychomotor Therapy Intervention Program improves development and behavior in very preterm infants (VPI) at 24-month corrected age (CA).


Clinical Trial Description

VPI < 30 week of amenorrhea were randomized, in a simple blind controlled trial. The psychomotor development was evaluated according to the Bayley Scales of Infant Development-III (BSID-III) at 2 years CA. An intermediate point was provided at 9 months CA. Pediatric standardized assessments and psychologist semi-directive interviews were conducted. Parents also completed a self-administering questionnaire relating to the post-traumatic stress. The intervention consisted on 20 therapy sessions between 2 and 9 months CA, in order to support infants' development, and parent-infant interactions and adjustment. Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03093337
Study type Interventional
Source University Hospital, Toulouse
Contact
Status Completed
Phase N/A
Start date December 1, 2007
Completion date July 8, 2017

See also
  Status Clinical Trial Phase
Terminated NCT02550054 - Erythropoietin in Premature Infants to Prevent Encephalopathy Phase 2
Completed NCT03827252 - Respiratory Stability and Vegetative Coupling During Neonatal Skin-to-skin Care
Active, not recruiting NCT03345069 - Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS)
Completed NCT04067206 - The Effects Of Auditory Interventions On Pain And Comfort In Premature Infants N/A
Completed NCT03911674 - Effects of Oral Stimulation in Preterm Infants Phase 3
Completed NCT03324126 - Individualized Fortification of Breast Milk N/A
Completed NCT03704012 - Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas) N/A
Active, not recruiting NCT03241082 - Ultrasound Assessment of BC in the NICU
Completed NCT03701906 - Effect of a Mixture of New Probiotic Strains in Preterm Infants N/A
Completed NCT02133716 - Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm Phase 4
Not yet recruiting NCT05543005 - Efficacy Study of an Audio Device Outside Incubator Allowing Broadcasting Maternal Voice on Stability in Preterm Infants N/A
Recruiting NCT03852641 - Feeding Premature Infants During Non-invasive Respiratory Support N/A
Active, not recruiting NCT03423914 - Efficacy of Expressive Writing in Mothers of Preterm Infants N/A
Recruiting NCT04648787 - A Study of Family-integrated Care for Reducing Uncertainty N/A
Recruiting NCT04866342 - Servo Controlled Oxygen Targeting (SCO2T) Study: Masimo vs. Nellcor N/A
Not yet recruiting NCT02534090 - Evaluation of Feeding Intolerance in Premature Infants Using Near Infrared Spectroscopy N/A
Not yet recruiting NCT02601872 - Erythropoietin in Premature Infants to Prevent Encephalopathy Phase 2
Recruiting NCT06212427 - Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs) N/A
Suspended NCT03939169 - The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP) N/A
Completed NCT03706586 - The Hilo Pilot -Trial to Assess Feasibility N/A