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A Parent Administered Sensorimotor Intervention and Developmental Outcome of Preterm Infants

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ClinicalTrials.gov Identifier: NCT03836326
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Sandra Fucile, Queen's University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Premature Infant Developmental Delay Other: Sensorimotor intervention Other: Control Not Applicable

Detailed Description:

Children who are born prematurely are at a higher risk of developing developmental delays than children born at term. Early experiences in the neonatal intensive care unit (NICU) can influence developmental outcomes. Sensorimotor interventions as well as parental engagement have been designed with the aim of improving the development of children born preterm. Substantial evidence supports the benefits of each intervention on improving developmental outcomes. However, there remains a significant gap in the literature on the efficacy of a parent administered sensorimotor intervention (PASI) program in the NICU on infant's development. The proposed study is designed to evaluate the potential benefits of such a program on infant's development. A randomized block clinical trial will be performed.

A total of 84 preterm infants (< 34 weeks gestation) will be recruited and randomized. Infants in the experimental group will receive the sensorimotor program,consisting of tactile (whole body) and oral input for 15 minutes, one time per day, for 10 days. Infants in the control group will receive standard care. The following outcomes will be monitored time to attainment of complete oral feeds (primary outcome), rate of weight gain, length of hospitalization, and developmental outcomes at 36 weeks corrected gestational age and at 4, 8, 12, 18 and 24 months corrected age. Results from this study will provide us with further knowledge on the impact of sensorimotor intervention on infants' developmental outcome as well as the effect of active parental involvement on infants' development. Provision of a PASI program is a safe and low cost effective intervention that may increase the development and quality of life of preterm born children and their family.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized clinical trail
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Developmental Outcome of Preterm Infants Enrolled in a Randomized Clinical of a Parent Administered Sensorimotor Intervention in the Neonatal Intensive Care Unit
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : July 1, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Sensorimotor intervention
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
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.
Other Names:
  • Supplemental stimulation
  • Sensory input
  • Tactile input
  • Oral input
Control
Infants in the control group will receive standard care only.
 Other: Control
Routine care provided by health professionals in the NICU


Outcome Measures
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Primary Outcome Measures :
  1. Attainment of independent oral feeds [ Time Frame: 3 years ]
    Number of days to transition from complete tube to complete oral feeds.


Secondary Outcome Measures :
  1. Weight gain [ Time Frame: 3 years ]
    Weight gain velocity from start of study until hospital discharge

  2. Length of hospital stay [ Time Frame: 3 years ]
    Number of days from birth to discharge home

  3. Test of infant motor performance [ Time Frame: 3 years ]
    A standardized assessment measuring postural control and motor function in infants from 32 weeks gestation to 4 months corrected gestational age. Total raw scores range from 0-142, higher scores represent better motor function.


Eligibility Criteria
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Ages Eligible for Study:   up to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Infants born with a metabolic disorder or congenital abnormality
  • Infants whose parents are unable to participate due to cognitive, physical or social issues.
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): NCT03836326


Contacts
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Contact: Sandra Fucile, PhD 613-548-6046 ext 2179 sandra.fucile@queensu.ca
Contact: Kimberly Dow, MD 613-548-6046 kdow@queensu.ca

Locations
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Canada, Ontario
Kingston Health Sciences Center Recruiting
Kingston, Ontario, Canada, k7l2v7
Contact: Sandra Fucile, PhD    613-548-9999 ext 2179    sandra.fucile@queensu.ca   
Sponsors and Collaborators
Dr. Sandra Fucile
Investigators
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Principal Investigator: Sandra Fucile, PhD Queen's University
More Information
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Responsible Party: Dr. Sandra Fucile, PI, Queen's University
ClinicalTrials.gov Identifier: NCT03836326    
Other Study ID Numbers: 6023834
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
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 Dr. Sandra Fucile, Queen's University:
Prematurity
Development
Parental engagement
Parental satisfaction