A Parent Administered Sensorimotor Intervention and Developmental Outcome of Preterm Infants

D

Dr. Sandra Fucile

Status

Enrolling

Conditions

Developmental Delay
Premature Infant

Treatments

Other: Sensorimotor intervention
Other: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT03836326
6023834

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 estimated patients

Sex

All

Ages

Under 34 weeks old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

84 participants in 2 patient groups

Sensorimotor intervention
Experimental group
Description:
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.
Treatment:
Other: Sensorimotor intervention
Control
Other group
Description:
Infants in the control group will receive standard care only.
Treatment:
Other: Control

Trial contacts and locations

1

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Central trial contact

Kimberly Dow, MD; Sandra Fucile, PhD

Data sourced from clinicaltrials.gov

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