A Parent Administered Sensorimotor Intervention and Developmental Outcome of Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2024-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sensitivity Training For Parents of Preterm Infants

NCT00883974

Development Preterm Birth

COMPLETED NA

A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways

NCT01807533

Premature Birth

COMPLETED NA

Sensory Optimization of the Hospital Environment

NCT05230199

Preterm Parent-Child Relations Parents +2 more

RECRUITING NA

Reading Stories to Premature Babies Reinforces Mother-baby Synchronies?

NCT03114644

Premature Infant Mother-Baby Synchrony

UNKNOWN NA

Family-Centered Intervention for Preterm Children: Effects at School Age and Biosocial Mediators

NCT03668626

Premature Birth

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premature Infant Developmental Delay

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized clinical trail

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Sensorimotor intervention

Intervention Type 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.

Story telling attention refocusing intervention

Intervention Type OTHER

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

Control

Infants in the control group will receive standard care only.

Group Type OTHER

Control

Intervention Type OTHER

Routine care provided by health professionals in the NICU

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Control

Routine care provided by health professionals in the NICU

Intervention Type OTHER

Story telling attention refocusing intervention

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Supplemental stimulation Sensory input Tactile input Oral input STAR

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Maximum Eligible Age

34 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No