Evaluation of an Early Preventive and Educational Care Pathway for Moderate and Late Preterm Infants. A Randomized Controlled Study (PREKINOU)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infant, Premature
• Intervention / Treatment: Other: PREKINOU intervention

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Birth between 32 weeks + 0 days and 36 weeks + 6 days of gestational age at Flers Hospital or Caen University Hospital (CHU de Caen).
• Maternal and paternal age ≥ 18 years.
• At least one parent present in the hospital for more than 3 hours per day.
• Residence within a 60-kilometre radius of the place of birth.
• Parents' ability to understand and communicate in French, both orally and in writing.
• Written informed consent signed by the legal representatives holding parental responsibility.
• Affiliation with a social security system.

Exclusion Criteria:

• Suspected hypoxic-ischaemic encephalopathy requiring therapeutic hypothermia.
• Perinatal arterial ischaemic stroke, diagnosed between 20 weeks of fetal life and 28 days after birth.
• Abnormal brain growth: microcephaly, defined as a head circumference ≤ -2 standard deviations (SD) at birth and subsequently confirmed, or macrocephaly ≥ +3 SD for gestational age, persisting after a second measurement.
• First-degree family history of severe neurodevelopmental disorders (sibling or parent).
• Symptomatic congenital cytomegalovirus infection or other congenital infections affecting the fetus, including toxoplasmosis, Zika virus infection and rubella.
• Bacterial or herpesvirus encephalitis and meningoencephalitis.
• Complex congenital heart disease requiring surgery, including transposition of the great arteries and hypoplastic left heart syndrome.
• Prenatal exposure to a major toxic agent, including certain antiepileptic drugs or severe alcohol exposure and/or exposure associated with signs of fetal alcohol spectrum disorder.
• Major, prolonged and repeated surgery (cardiac, cerebral, abdominal or thoracic).
• Cortical blindness or retinopathy of prematurity resulting in blindness.
• Congenital musculoskeletal abnormality.
• Chromosomal or genetic abnormality.
• Infants born to mothers or fathers with documented histories of social problems (including child abuse, neglect or parental substance misuse) or mental illness.
• Multiple pregnancy involving three or more premature infants.
• Bronchopulmonary dysplasia with ongoing oxygen dependency after 36 weeks of gestational age.
• Any gastrointestinal or other condition preventing the infant from being placed in the prone position.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Infants will receive early preventive and educational care pathway (PREKINOU) in addition to standard care and mandatory medical examinations	Other: PREKINOU intervention; Specific early preventive and educational care pathway for moderately and late preterm (MLPT) infants.
No Intervention: Control group; Infants will receive only standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	9 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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).	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.	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.	9 months

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: VIRGILE FILLION BROQUET, CMPR (Center for Physical Medicine and Rehabilitation) La Clairière

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030

Study Registration Dates

• First Submitted: November 4, 2026
• First Submitted That Met QC Criteria: November 4, 2026
• First Posted (Actual): November 10, 2026

Study Record Updates

• Last Update Posted (Actual): November 10, 2026
• Last Update Submitted That Met QC Criteria: November 4, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: 25-0295

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No