NCT04783220

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

April 4, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

January 15, 2021

Last Update Submit

April 2, 2025

Conditions

Behavioral Assessment of ChildrenEarly Intervention

Keywords

Preterm infantParental stressEarly child developmentParenting in the neonatal intensive care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Physiological state- Respiratory rate

    1 year

  • Physiological state - Oxygen saturation

    1 year

  • Neurobehavioral state

    1 year

  • Parental Knowledge assessment

    Before hospital discharge

  • Parental stress

    1 year

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Comprehensive structured parent intervention

Control

NO INTERVENTION

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

Interventions

Comprehensive structured parent interventionBEHAVIORAL

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

Eligibility Criteria

Age1 Day - 21 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut

Beirut, Hamra, 1107 2020, Lebanon

Location

Related Links

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Lama Charafeddine, MD

    American University of Beirut Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2021

First Posted

March 5, 2021

Study Start

November 1, 2021

Primary Completion

October 14, 2024

Study Completion

June 30, 2025

Last Updated

April 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

LE(1)