Status:
UNKNOWN
Epigenetics and Protective Factors in the Preterm Infant
Lead Sponsor:
IRCCS Eugenio Medea
Conditions:
Preterm Birth
Parent-Child Relations
Eligibility:
All Genders
Up to 30 years
Brief Summary
Preterm infants (PT) spend their first weeks of life in the Neonatal Intensive Care Unit (NICU) where they are exposed to unfavorable conditions with different effects on child development including l...
Detailed Description
Background: preterm infants (PT) spend their first weeks of life in the Neonatal Intensive Care Unit (NICU) where they are exposed to conditions with different effects on child development including l...
Eligibility Criteria
Inclusion
- Inclusion criteria for PT children are:
- gestational age: 26+0 to 31+6 weeks;
- absence of documented neurological pathology;
- absence of sensory deficits;
- absence of malformative syndromes and/or major malformations.
- Inclusion criteria for FT infants are:
- gestational age ≥ 37weeks;
- birth weight ≥ 2,500g;
- APGAR 5' ≥ 7 - delivery without any complications for the child and/or mother;
- no pre/postnatal/postnatal clinical conditions;
- no hospitalizations at the time of birth or postpartum;
- absence of malformative syndromes and/or major malformations.
- Inclusion criteria for mothers are:
- mothers of Italian nationality;
- mother over 18 years of age;
- mother with absence of manifest psychiatric and/or cognitive pathologies (must be previously diagnosed major psychiatric pathologies);
- non-addicted/no habitual use of psychotropic medications, drugs, alcohol no smoking;
- non-single-parent families.
- Exclusion criteria: refer to inclusion criteria.
Exclusion
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 4 2024
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04804280
Start Date
January 1 2019
End Date
September 4 2024
Last Update
October 18 2023
Active Locations (1)
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1
Associalzione La Nostra Famiglia - IRCCS Eugenio Medea
Bosisio Parini, Lecco, Italy, 23842