An interventional study of PREKINOU intervention in Infant, Premature, sponsored by University Hospital, Caen. Not yet recruiting. Open to participants aged 32 Weeks to 36 Weeks. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University Hospital, Caen · Not applicable, Interventional, and Prevention
Prematurity is associated with a high risk of neurodevelopmental disorders (NDDs). The prognosis for moderate and late preterm infants (32 to \<37 weeks of gestational age) is better than that for very preterm infants (\<32 weeks of gestational age).
According to the French National Authority for Health (Haute Autorité de Santé, HAS), moderate and late preterm (MLPT) infants are at moderate risk of NDDs. However, although their risk is lower than that of very preterm infants, it remains significant. Recent research has challenged the misconception that MLPT births are associated with little or no increase in developmental delays compared with full-term births. The risk of NDDs is two to three times higher in these infants than in infants born at term. Prematurity, regardless of its degree, affects the motor and cognitive performance of children born preterm. Impaired neurological development persists at different follow-up ages.
Moderate and late preterm infants account for 85% of all preterm births. Consequently, the number of infants with NDDs is substantial, highlighting the need for appropriate care to limit the impact on the healthcare system.
When an NDD is suspected, the HAS recommends providing parental guidance to help parents initiate activities at home while awaiting the implementation of early intervention. However, these children currently receive no standardised follow-up. The lack of specific assessment of MLPT infants, due to underestimation of their neuromotor risk, leads to delays in care. These delays may result in delayed neuromotor development and potentially long-term sequelae. Yet interventions initiated before discharge from the neonatal unit have the greatest positive impact on the neuromotor development of preterm infants.
Parental education is an effective early intervention strategy. It provides a significant opportunity to improve young children's motor, language, cognitive and socio-emotional development, as well as attachment. It also helps parents develop a better understanding of their infants and promotes parent-infant interactions.
We hypothesise that an early preventive care pathway (PREKINOU) could improve the motor development scores of MLPT infants at 9 months of corrected age.
The objective of the study is to evaluate the effectiveness of an early preventive and educational care pathway (PREKINOU) on the motor development of MLPT infants at 9 months of corrected age (41 weeks ± 14 days), compared with standard care.
This study will include 92 infants born moderately or late preterm. The infants will be randomised into two groups. Infants in the experimental group (n = 46) will follow the PREKINOU pathway in addition to standard care and mandatory medical examinations, both in the maternity unit and after discharge home, until 13 weeks of corrected age (CA).
At 9 months of corrected age (41 weeks ± 14 days), infants in both the experimental and control groups will undergo a blinded assessment using the motor, cognitive and language subscales of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4). The assessment will be conducted by a psychomotor therapist trained in the administration of this scale.
Parents' perceptions of their ability to care for their infants will also be assessed at 9 months of corrected age using the Maternal Perceived Parental Self-Efficacy questionnaire (PMP-SE).
The level of parental engagement in the experimental group will be measured using logbooks. Parental support for the development of infants in both the experimental and control groups will be assessed at 9 months of corrected age using a questionnaire.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 92 is close to the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University Hospital, Caen is the lead sponsor of 512 studies on the registry; 82 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infants will receive early preventive and educational care pathway (PREKINOU) in addition to standard care and mandatory medical examinations
Other: PREKINOU intervention
Infants will receive only standard care
Specific early preventive and educational care pathway for moderately and late preterm (MLPT) infants.
Motor subscale of the Bayley Scales
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
Time frame: 9 month
Language and Cognitive Subscales of the Bayley-4
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.
Time frame: 9 months
General Movement Assessment
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
Time frame: 13 weeks
Maternal Perceived Parental Self-Efficacy Questionnaire (PMP-SE)
Parents in both groups will complete this questionnaire at 9 months of corrected age (41 weeks ± 14 days).
Time frame: 9 months
Level of Parental Engagement
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.
Time frame: From enrollment to the end of the programme"
Questionnaire on Parental Support for the Development of MLPT Infants
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.
Time frame: 9 months
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