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NCT07928830
Evaluation of an Early Preventive and Educational Care Pathway for Moderate and Late Preterm Infants. A Randomized Controlled Study
Conditions: Infant, Premature
Sex: All
Ages: 32 Weeks – 36 Weeks
Healthy volunteers: No
Phase: NA
Enrollment: 92
Sponsor: University Hospital, Caen
Summary
Prematurity is associated with a high risk of neurodevelopmental disorders (NDDs). The prognosis for moderate and late preterm infants (32 to \
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07928830). StuddyBuddy aggregates publicly available trial information.