Trial · NCT07903766
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assessment of preterm behavior using the NICU Network Neurobehavioral Scale (NNNS) neurobehavioral scale | 37 weeks of amenorrhea before the premature baby is discharged from hospital | The NNNS neurobehavioral scale comprises 13 dimensions: habituation (3 items rated between 1 and 9), orientation (7 items rated between 1 and 9), self-regulation (15 items rated between 1 and 9), hypertonia (10 items rated between 0 and 10), hypotonia (10 items rated between 0 and 10), asymmetry reflexes (16 items rated between 0 and 16), non-optimal reflexes (15 items rated between 0 and 15), excitability (15 items rated between 0 and 15), lethargy (15 items rated between 0 and 15), arousal (7 items rated between 1 and 9), quality of movement (6 items rated between 1 and 9), stress ( 50 items rated between 0 and 1) and handling tolerance (8 items rated between 0 and 1). This assessment is carried out at 37 weeks of amenorrhea by a trained pyschomotrician before the premature baby is discharged from hospital Higher scores reflect better neurobehavioral construction. |
| Secondary | Average weight gain (g/kg/d) | Day -1, at Day 1 and Day 10, at discharge and at 3 months corrected age | |
| Secondary | Baby's tolerance of multi-sensory stimulation | days 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of the multi-sensory stimulation | Simplified NIDCAP grid evaluation (Tolerance) |
| Secondary | Total length of hospital stay | At the time of hospital discharge (up to 6 months) | Number of days in hospital |
| Secondary | Duration of skin-to-skin contact per day from inclusion to incubator discharge | during hospitalisation (up to 6 months) and at the time of hospitalisation discharge (up to 6 months) | Hour(s)/day of skin-to-skin contact |
| Secondary | Duration of breast-feeding | At the time of hospital discharge (up to 6 months) and at the medical consultation at 3 months of corrected age | Number of days breastfeeding or bottle-feeding with breast milk |
| Secondary | Post-traumatic stress of mother and father | At the medical consultation at 3 months of corrected age | Parents will complete the Perinatal Posttraumatic stress disorder (PPQ) questionnaire |
| Secondary | Mother's and father's anxiety levels | At inclusion, at the baby's discharge from hospital (up to 6 months), and at the medical consultation at 3 months of corrected | Anxiety symptoms will be assessed using the Spielberger scale : from a score of 20 (no anxiety) to a score of 80 (high anxiety) |
| Secondary | Quality of life of mother and father | At the medical consultation at 3 months of corrected age | Quality of life will be assessed using the questionnaire (SF 36) |
| Secondary | Spontaneous motricity | At the medical consultation between 3 and 4 months of corrected age | Spontaneous motricity will be assessed using the Prechtl technique via video recording |
| Secondary | Staturo-ponderal growth | During hospitalization (up to 6 months) and at the time of hospitalisation discharge (up to 6 months), then at the medical consultation at 3 months of corrected age | |
| Secondary | Parent-child interaction | At the medical consultation at 3 months of corrected age | Interactive Behavior coding will be carried out during breastfeeding or bottle-feeding, using a video recording |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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