Clinical trial NCT04783220: PaREnting ProgrAm to Enhance PREterm Infants' Health and Development (PREPARE Trial)
Official title: Comprehensive PaREnting ProgrAm to Enhance PREterm Infants' Health and Development: A Randomized Controlled Trial (PREPARE Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Behavioral Assessment of Children
Early Intervention
Keywords: Preterm infant
Parental stress
Early child development
Parenting in the neonatal intensive care
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 72
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Child developmental outcome
timeFrame: 9 months
Secondary outcomes:
measure: Physiological state- Respiratory rate
timeFrame: 1 year
measure: Physiological state - Oxygen saturation
timeFrame: 1 year
measure: Neurobehavioral state
timeFrame: 1 year
measure: Parental Knowledge assessment
timeFrame: Before hospital discharge
measure: Parental stress
timeFrame: 1 year
measure: Behavioral parenting activities
timeFrame: 1 year
measure: Parents perceptions
timeFrame: 1 year
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut
state: Hamra
Study officials:
affiliation: American University of Beirut Medical Center
name: Lama Charafeddine, MD
role: PRINCIPAL_INVESTIGATOR
References: