Evaluation of an Early Preventive and Educational Care Pathway for Moderate and Late Preterm Infants. A Randomized Controlled Study - NCT07928830

Sponsor: University Hospital, Caen Conditions: Infant, Premature 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.