Comprehensive PaREnting ProgrAm to Enhance PREterm Infants' Health and Development: A Randomized Controlled Trial (PREPARE Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Child developmental outcome
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Day to 21 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Intervention
The parents of babies in this group will receive an educational and intervention program
Intervention: Comprehensive structured parent intervention (Behavioral)
Control
The parents of babies in this group will receive the standard parent education and follow-up.
Outcomes
Primary Outcomes
Child developmental outcome
Time Frame: 9 months
The developmental outcome of preterm children will be assessed using the Ages and Stages Questionnaire at 9 months of corrected age. The ASQ-3 covers 5 area of child development : Gross Motor, Fine Motor, Problem Solving, Personal-Social, Communication. Scores for each area should range between minimum 0 and maximum 60. Higher scores indicate that the child is developing properly.
Secondary Outcomes
- Physiological state- Respiratory rate(1 year)
- Physiological state - Oxygen saturation(1 year)
- Neurobehavioral state(1 year)
- Parental Knowledge assessment(Before hospital discharge)
- Parental stress(1 year)
- Behavioral parenting activities(1 year)
- Parents perceptions(1 year)