A Parent Administered Sensorimotor Intervention and Developmental Outcome of Preterm Infants

Developmental Delay Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03836326
• Other study ID #: 6023834
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2024
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 34 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Developmental Delay
• Premature Infant

Intervention

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.
• Control
Routine care provided by health professionals in the NICU
• Story telling attention refocusing intervention
A contact-free intervention where parents share stories with their infant for 10 minutes 3 times per week.

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Center	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Sandra Fucile

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attainment of independent oral feeds	Number of days to transition from complete tube to complete oral feeds.	3 years
Secondary	Weight gain	Weight gain velocity from start of study until hospital discharge	3 years
Secondary	Length of hospital stay	Number of days from birth to discharge home	3 years
Secondary	Test of infant motor performance	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.	3 years
Secondary	Acute stress of parents	The PSS: NICU assessment was used to assess acute stress of parents	3 years