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Not Yet Recruiting 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07928830). StuddyBuddy aggregates publicly available trial information.