A Parent Administered Sensorimotor Intervention and Developmental Outcome of Preterm Infants

NCT03836326 | Completed

• 1 other identifier: 6023834
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Advances in medical technologies over the last three decades have increased survival rates in infants born preterm . Preterm infants are at high risk of developing developmental delays. Implementation of effective strategies aimed at improving the developmental outcome of preterm born children is critical. The proposed study is designed to evaluate the addition of a parent administered sensorimotor program on the developmental outcome of infants who are born preterm.

Conditions

Premature Infant; Developmental Delay

Keywords

Prematurity; Development; Parental engagement; Parental satisfaction

Outcome Measures

Primary Outcomes (1)

• Attainment of independent oral feeds

  Number of days to transition from complete tube to complete oral feeds.

  3 years

Secondary Outcomes (4)

• Weight gain

  3 years

• Length of hospital stay

  3 years

• Test of infant motor performance

  3 years

• Acute stress of parents

  3 years

Study Arms (2)

Sensorimotor intervention

EXPERIMENTAL

Is a 15-minute intervention consisting of tactile (i.e., stroking the whole body) and oral input (i.e., stroking the oral structures) for 15 minutes duration. The program will start 24 hours after nasal continuous positive airway pressure (NCPAP) is discontinued and 24 hours after 80 ml/kg/day of enteral feeds are tolerated. The program will be administered once a day for 10 days, within a 14-day period. The parents will perform all the interventions in the NICU. The infants will remain in the isolette for the duration of the program. This intervention does not involve any drugs or medical procedures. It is an intervention commonly used by occupational and physical therapists in the neonatal intensive care unit.

Other: Sensorimotor intervention; Other: Story telling attention refocusing intervention

Control

OTHER

Infants in the control group will receive standard care only.

Other: Control

Interventions

Sensorimotor intervention OTHER

Sensorimotor intervention involves, stroking of the whole body including the oral structures, trunk and limbs. This intervention does not involve any drugs or medical procedure.

Also known as: Supplemental stimulation, Sensory input, Tactile input, Oral input

Sensorimotor intervention

Control OTHER

Routine care provided by health professionals in the NICU

Control

Story telling attention refocusing intervention OTHER

A contact-free intervention where parents share stories with their infant for 10 minutes 3 times per week.

Also known as: STAR

Sensorimotor intervention

Eligibility Criteria

• Age: Up to 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born \< 34 weeks gestation
• Infants whose parent (s) intend on visiting regularly (\> 5 days)

You may not qualify if:

• Infants born with a metabolic disorder or congenital abnormality
• Infants whose parents are unable to participate due to cognitive, physical or social issues.

Sponsors & Collaborators

• Dr. Sandra Fucile: lead

Study Sites (1)

Kingston Health Sciences Center

Kingston, Ontario, k7l2v7, Canada

Location

MeSH Terms

Conditions

Premature Birth; Learning Disabilities

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Sandra Fucile, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: A prospective randomized block clinical trial will be conducted. Infants will be randomized into experimental (PASI program) and control (standard care program) groups using a block size of four per arm, where the first set of four participants will be in the experimental group and once they have completed the intervention, the subsequent set of four participants will be in the control group. A randomized block design was selected because the treatment assignment cannot be masked. The block randomization procedure will reduce the potential for contamination between groups.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Model Details: Randomized clinical trail

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 11, 2019
• Study Start: July 1, 2019
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)