Active — Not RecruitingNot Applicable

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

Lebanon72 participantsStarted 2021-11-01

Plain-language 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.

Who can participate

Age range1 Day – 21 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Child developmental outcome

Timeframe: 9 months

Trial details

NCT IDNCT04783220

SponsorAmerican University of Beirut Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-14

View on ClinicalTrials.gov More Behavioral Assessment of Children trials