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NCT Number: NCT04783220

PaREnting ProgrAm to Enhance PREterm Infants' Health and Development (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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Behavioral Assessment of Children Early Intervention Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–21 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American University of Beirut

Beirut, Hamra, 1107 2020, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Comprehensive structured parent intervention

Behavioral
  • 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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

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

Acronym: PREPARE

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Mar 5, 2021
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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