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

Comprehensive PaREnting ProgrAm to Enhance PREterm Infants' Health and Development: A Randomized Controlled Trial (PREPARE Trial)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Early Intervention; Behavioral Assessment of Children
• Intervention / Treatment: Behavioral: Comprehensive structured parent intervention

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Hamra
    • Beirut, Hamra, Lebanon, 1107 2020
      • American University of Beirut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 weeks (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The parents of babies in this group will receive an educational and intervention program	Behavioral: Comprehensive structured parent intervention; Educational sessions and coaching on infants' behavior cues; Skills on motor stimulation; Written instructions for play and stimulation activities at discharge; Multidisciplinary follow-up; Developmental tracking and advice via a mobile app
No Intervention: Control; The parents of babies in this group will receive the standard parent education and follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child developmental outcome	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.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological state- Respiratory rate	Physiological parameters including respiratory rate will be retrieved from the bedside monitors.	1 year
Physiological state - Oxygen saturation	Physiological parameters including oxygen saturation will be retrieved from the bedside monitors.	1 year
Neurobehavioral state	Behavioral state will be assessed by a cerified trained developmental specialist using a 7-point score that include: (i) Quiet/deep sleep, (ii) Active sleep, (iii) Awake State, (iv) drowsy, (v) quiet alert, (vi) active alert, (vii) crying	1 year
Parental Knowledge assessment	Parental knowledge assessment test will be administered before and after the education sessions using 10 true/false questions regarding topics addressed in the sessions.	Before hospital discharge
Parental stress	The Arabic parenting stress index short form questionnaire will be used. The PSI-SF is a self-administered questionnaire and consists of 36 items divided into three subscales of 12 items each: parental distress, parent-child dysfunctional interaction and difficult child. For each subscales scores ranges should be between 12 and 60. For the total stress score , the minimum score is 36 and the maximum is 180. Higher scores mean more depressive symptoms.	1 year
Behavioral parenting activities	A questionnaire derived from the UNICEF MICS 6 questionnaire will be used. MICS or "MULTIPLE INDICATOR CLUSTER SURVEY" is a tool used to assess the activities of parents with their infants.	1 year
Parents perceptions	The Perceived Maternal Parenting Self-Efficacy questionnaire is a standardized valid and reliable instrument to assess parent's perceptions of their ability to care for their infants. PMP-SE is composed of 20 items divided into four subscales: care taking procedures, evoking behaviours, reading behaviours or signalling, and situational beliefs. Those items are formulated as statements using a five-point Likert scale. Scoring ranges from 20 to 80 where a higher score indicates a higher self-efficacy.	1 year

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Lama Charafeddine, MD, American University of Beirut Medical Center

Publications and helpful links

Helpful Links

• Agency for Healthcare Reserach and Quality (2018). NICU-2-HOME: Using Health IT to Support Parents of NICU Graduates Transitioning to Home (Illinois) | AHRQ National Resource Center; Health Information Technology: Best Practices Transforming Quality, S

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): October 14, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Preterm infant; Parental stress; Early child development; Parenting in the neonatal intensive care
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: SBS-2020-0365

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No