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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

32 weeks - 36 weeks

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

92 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (0)

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No locations are listed. Use the official study contact.

Study team and timeline

Lead sponsor

University Hospital, Caen

Study start

2027-01 Estimated

Primary completion

2030-11 Estimated

Study completion

2030-11 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.