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

NCT04783220 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-04-04

No results posted yet for this study

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.

Conditions

  • Behavioral Assessment of Children
  • Early Intervention

Interventions

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

Sponsors & Collaborators

  • American University of Beirut Medical Center

    lead OTHER

Principal Investigators

  • Lama Charafeddine, MD · American University of Beirut Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
21 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2024-10-14
Completion
2025-06-30

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04783220 on ClinicalTrials.gov