PaREnting ProgrAm to Enhance PREterm Infants' Health and Development (PREPARE Trial)

American University of Beirut Medical Center

Status

Active, not recruiting

Conditions

Behavioral Assessment of Children

Early Intervention

Treatments

Behavioral: Comprehensive structured parent intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04783220

SBS-2020-0365

Details and patient eligibility

About

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 have been proposed with mixed results. In low to middle-income countries, clinically relevant and effective low cost interventions empowering parents have yet to be established.

Full 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 is to develop a program in Arabic for parents of premature infants with the aim to increase their knowledge about short and long term problems of prematurity, increase their involvement in the care during their stay in the neonatal intensive care unit (NICU) and promote responsive and sensitive parenting in the NICU and after discharge. This is to empower parents and have them become active contributors to enhancing their infant's development through play activities and tracking of developmental milestones.

Enrollment

72 estimated patients

Sex

All

Ages

1 to 21 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.