Evaluation of an Early Preventive and Educational Care Pathway for Moderate and Late Preterm Infants. A Randomized Controlled Study
NCT07928830, Not applicable, Not yet recruiting, University Hospital, Caen
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Evaluation of an Early Preventive and Educational Care Pathway for Moderate and Late Preterm Infants. A Randomized Controlled Study | ClinicalTrials.gov |
| NCT number | NCT07928830 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 92 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Hospital, Caen | ClinicalTrials.gov |
| Conditions | Infant, Premature | ClinicalTrials.gov |
| Interventions | PREKINOU intervention | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Motor subscale of the Bayley Scales | 9 month | Infants' motor development will be assessed at 9 months of corrected age (41 weeks ± 14 days) using the Bayley Scales of Infant and Toddler Development, Fourth Edition (2022). Scores will be compared with the normative data from the French adaptation of the Bayley-4 | ClinicalTrials.gov |
| Secondary | Language and Cognitive Subscales of the Bayley-4 | 9 months | Infants' language and cognitive development will be assessed at 9 months of corrected age (41 weeks ± 14 days) using the Bayley Scales of Infant and Toddler Development, Fourth Edition (2022). Scores on the Cognitive and Language subtests will be compared with the normative data from the French adaptation of the Bayley-4. | ClinicalTrials.gov |
| Secondary | General Movement Assessment | 13 weeks | General Movements (GMs) will be assessed on two occasions in the experimental group: immediately before discharge from hospital or the maternity unit, and at 13 weeks of corrected age (3 months). In the control group, GMs will be assessed only at 13 weeks of corrected age. The Revised Motor Optimality Score (MOS-R) will be calculated for each infant during the video analysis of GMs performed at 13 weeks of corrected age | ClinicalTrials.gov |
| Secondary | Maternal Perceived Parental Self-Efficacy Questionnaire (PMP-SE) | 9 months | Parents in both groups will complete this questionnaire at 9 months of corrected age (41 weeks ± 14 days). | ClinicalTrials.gov |
| Secondary | Level of Parental Engagement | From enrollment to the end of the programme" | Parents will be asked to record the frequency of activities completed each week in logbooks . Adherence to the educational programme will be classified as follows: * Excellent adherence: parents complete at least two activities per day, on 5 out of 7 days. * Good adherence: parents complete at least two activities per day, on 3 out of 7 days. * Poor adherence: parents complete fewer than two activities per day, on 3 out of 7 days. | ClinicalTrials.gov |
| Secondary | Questionnaire on Parental Support for the Development of MLPT Infants | 9 months | To assess the impact of the PREKINOU pathway on parental support for infant development, parents will be asked to complete a questionnaire at the final assessment, at 9 months of corrected age (41 weeks ± 14 days). The questionnaire will address the following areas: The infant's environment, Positioning and daily routines, Sensory and motor stimulation and responses and adaptations to the infant's needs. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)