Status:
ACTIVE_NOT_RECRUITING
PaREnting ProgrAm to Enhance PREterm Infants' Health and Development (PREPARE Trial)
Lead Sponsor:
American University of Beirut Medical Center
Conditions:
Behavioral Assessment of Children
Early Intervention
Eligibility:
All Genders
1-21 years
Phase:
NA
Brief Summary
Preterm infants are at high risk of developmental delay or disabilities and they do benefit from early intervention programs. Many programs aiming at improving preterm infants' developmental outcome h...
Detailed Description
Education and intervention programs targeting parents of premature infants are lacking in low to middle income countries (LMIC) and in Arabic countries in particular. The main concept of this proposal...
Eligibility Criteria
Inclusion
- Couplets of parents and their preterm infants admitted to the NICU, who are \<35 weeks gestation at birth and who are deemed medically stable by their treating neonatologist.
Exclusion
- Infants with significant neurologic disorder precluding meaningful interaction with the parents as determined by the neurologist
- Infants with major congenital anomalies precluding meaningful interaction with the parents as determined by the neurologist
- Infants with systemic medical and/ or surgical conditions precluding interaction with the parents, other than preterm-related intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL).
- Parental refusal to participate
- Absence of clearance from the neonatologist
- Infants planned to be transferred to another facility for their NICU care.
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04783220
Start Date
November 1 2021
End Date
June 30 2025
Last Update
April 4 2025
Active Locations (1)
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1
American University of Beirut
Beirut, Hamra, Lebanon, 1107 2020