Trials / Active Not Recruiting
Active Not RecruitingNCT04783220
PaREnting ProgrAm to Enhance PREterm Infants' Health and Development (PREPARE Trial)
Comprehensive PaREnting ProgrAm to Enhance PREterm Infants' Health and Development: A Randomized Controlled Trial (PREPARE Trial)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- Sponsor
- American University of Beirut Medical Center · Academic / Other
- Sex
- All
- Age
- 1 Day – 21 Days
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Comprehensive structured parent intervention | 1. Educational sessions and coaching on infants' behavior cues 2. Skills on motor stimulation 3. Written instructions for play and stimulation activities at discharge 4. Multidisciplinary follow-up 5. Developmental tracking and advice via a mobile app |
Timeline
- Start date
- 2021-11-01
- Primary completion
- 2024-10-14
- Completion
- 2025-06-30
- First posted
- 2021-03-05
- Last updated
- 2025-04-04
Locations
1 site across 1 country: Lebanon
Source: ClinicalTrials.gov record NCT04783220. Inclusion in this directory is not an endorsement.