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

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ClinicalTrials.gov Identifier: NCT04783220
Recruitment Status : Recruiting
First Posted : March 5, 2021
Last Update Posted : February 18, 2022
Sponsor:
Information provided by (Responsible Party):
American University of Beirut Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Behavioral Assessment of Children Early Intervention Behavioral: Comprehensive structured parent intervention Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comprehensive PaREnting ProgrAm to Enhance PREterm Infants' Health and Development: A Randomized Controlled Trial (PREPARE Trial)
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : January 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
The parents of babies in this group will receive an educational and intervention program
 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
No Intervention: Control
The parents of babies in this group will receive the standard parent education and follow-up.


Outcome Measures
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Primary Outcome Measures :
  1. Child developmental outcome [ Time Frame: 9 months ]

    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.



Secondary Outcome Measures :
  1. Physiological state- Respiratory rate [ Time Frame: 1 year ]
    Physiological parameters including respiratory rate will be retrieved from the bedside monitors.

  2. Physiological state - Oxygen saturation [ Time Frame: 1 year ]
    Physiological parameters including oxygen saturation will be retrieved from the bedside monitors.

  3. Neurobehavioral state [ Time Frame: 1 year ]
    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

  4. Parental Knowledge assessment [ Time Frame: Before hospital discharge ]
    Parental knowledge assessment test will be administered before and after the education sessions using 10 true/false questions regarding topics addressed in the sessions.

  5. Parental stress [ Time Frame: 1 year ]

    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.


  6. Behavioral parenting activities [ Time Frame: 1 year ]
    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.

  7. Parents perceptions [ Time Frame: 1 year ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   up to 21 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04783220


Contacts
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Contact: Lama Charafeddine, MD 009611350000 ext 5874 lc12@aub.edu.lb

Locations
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Lebanon
American University of Beirut Recruiting
Beirut, Hamra, Lebanon, 1107 2020
Contact: Lama Charafeddine, MD    009611350000 ext 5874    lc12@aub.edu.lb   
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
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Principal Investigator: Lama Charafeddine, MD American University of Beirut Medical Center
More Information
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Additional Information:

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Responsible Party: American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT04783220    
Other Study ID Numbers: SBS-2020-0365
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: February 18, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by American University of Beirut Medical Center:
Preterm infant
Parental stress
Early child development
Parenting in the neonatal intensive care
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications