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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Two Early Treatments for Premature Babies and Their Effects Over Time

NCT07261046

Premature - Weight 1000g-2499g or Gestation of 28-37weeks Premature Baby 26 to 32 Weeks Premature Baby 33 to 36 Weeks +1 more

NOT_YET_RECRUITING NA

The Use of an Age-linked App for Parents During and After a NICU Stay

NCT03232190

Premature Birth

UNKNOWN NA

Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health

NCT06688695

Premature Infant Premature Babies

RECRUITING NA

Improving Parental Knowledge: Supplementation of Prematurity Counseling With Written Information

NCT01418950

Premature Birth

COMPLETED NA

Preemie Prep For Parents (P3): Home Antenatal Prematurity Education

NCT04093492

Premature Birth Decision Making Prenatal Care +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Behavioral Assessment of Children Early Intervention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

The parents of babies in this group will receive an educational and intervention program

Group Type EXPERIMENTAL

Comprehensive structured parent intervention

Intervention Type BEHAVIORAL

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

Control

The parents of babies in this group will receive the standard parent education and follow-up.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

21 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes