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Completed

NCT Number: NCT03836326

A Parent Administered Sensorimotor Intervention and Developmental Outcome of Preterm Infants

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.

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Key information

Conditions

Premature Infant Communication Disorders Developmental Delay Female Urogenital Diseases and Pregnancy Complications Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Urogenital Diseases

Age range

Up to 34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kingston Health Sciences Center

Kingston, Ontario, k7l2v7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

Other names: Supplemental stimulation, Sensory input, Tactile input, Oral input

Control

Other

Routine care provided by health professionals in the NICU

Story telling attention refocusing intervention

Other

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

Other names: STAR

Primary outcomes

  1. Attainment of independent oral feeds

    Time frame: 3 years

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

Secondary outcomes

  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.

  4. Acute stress of parents

    Time frame: 3 years

    The PSS: NICU assessment was used to assess acute stress of parents

Sponsors and collaborators

Lead sponsor

Dr. Sandra Fucile

Other

Registry information

Official study title

Developmental Outcome of Preterm Infants Enrolled in a Randomized Clinical of a Parent Administered Sensorimotor Intervention in the Neonatal Intensive Care Unit

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Feb 11, 2019
Registry last updated
May 30, 2024

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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