Sensorimotor intervention for Infants, Premature

Phase-Based Estimates
1
Effectiveness
1
Safety
Kingston Health Sciences Center, Kingston, Canada
+1 More
Sensorimotor intervention - Other
Eligibility
< 18
All Sexes
Eligible conditions
Infants, Premature

Study Summary

This study is evaluating whether a parent administered sensorimotor program can improve developmental outcomes for preterm infants.

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Eligible Conditions

  • Infants, Premature
  • Developmental Delay (Disorder)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Sensorimotor intervention will improve 1 primary outcome and 3 secondary outcomes in patients with Infants, Premature. Measurement will happen over the course of 3 years.

3 years
Attainment of independent oral feeds
Length of hospital stay
Test of infant motor performance
Weight gain

Trial Safety

Trial Design

2 Treatment Groups

Control
Sensorimotor intervention

This trial requires 84 total participants across 2 different treatment groups

This trial involves 2 different treatments. Sensorimotor Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Sensorimotor intervention
Other
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.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 years for reporting.

Closest Location

Kingston Health Sciences Center - Kingston, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Infants born < 34 weeks gestation
Infants whose parent (s) intend on visiting regularly (> 5 days)

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of infants, premature?

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The signs and symptoms of premature newborns vary by infant's gestational age. The premature newborn must be assessed by health care providers in order to determine which interventions are required. The newborn must then receive appropriate care.\n

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What are common treatments for infants, premature?

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Common treatment for infants, premature include nutritional supplementation, antibiotics, respiratory support, and oxygen therapy. Infants receiving prolonged mechanical ventilation may require a prolonged hospitalization. Physicians take a thorough medical history of the infant throughout their medical care. Early intervention is also key to reducing the need for hospitalization and improving long-term outcomes.\n\n- "

"Aldo Pago\n\nAldo Emilio Pago y Martínez (August 25, 1937 – October 27, 2010) was a Cuban professional baseball player. He made his major league debut with the New York Yankees in. He batted right-handed and threw right-handed.

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How many people get infants, premature a year in the United States?

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Most infants and children are born prematurely in the U.S., with 6.7 million having a birth birth certificate preterm. This is one of the highest rates in the world. The data is more informative over time than when compiled in single year tables; for example, 4.1 million were born prematurely in 1974, compared with 5.5 million births in 1999.

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What causes infants, premature?

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For premature infants no clear cause has been identified. However, it is likely that many of their complications (e.g. infection, feeding difficulties, sudden death) are caused by an imbalance or imbalance between good or bad substances in the body. Many infant diseases are the result of an imbalance between good and bad things in the body.\n

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Can infants, premature be cured?

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Findings from a recent study points to an increasing interest of new experimental and preliminary clinical treatment approaches for infants, premature children, and children who have not responded. This is the first phase II trial for infant patients in the US as well as in the world.

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What is infants, premature?

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Infants, premature is a term used mostly to describe babies under 1000 g in weight who are born before 39 weeks in the gestation period. These babies are thought to be premature because they are small and underdeveloped and because they emerge prematurely. The average birth weight in the UK is about 4 kg. Most live in close proximity to or in a Maternity Hospital. Infants are premature because of the number of illnesses they have. These are often due to infections by organisms that are present in the birth canal. These organisms and diseases can affect the fetus but they can also affect adults too.

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Who should consider clinical trials for infants, premature?

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Many infants with [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) that cannot be managed by standard therapies have not been investigated in clinical trials. Clinical trials may be necessary to test innovative therapeutic approaches in infants who have chronic pain, are not improved with standard treatments, and whose pain does not respond to treatment.

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Does sensorimotor intervention improve quality of life for those with infants, premature?

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Interventions targeting infants who have a diagnosis of CP and are born at an SGA seem to have an effect on improving their quality of life. This could be due to the intervention having a positive emotional impact. Larger multisite studies of this type are warranted.

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What is the latest research for infants, premature?

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Power shows [recent randomized clinical trials focusing on infants, premature] that, although not conclusive, studies have demonstrated the potential for these infants to survive and thrive.

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What does sensorimotor intervention usually treat?

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Sensorimotor intervention is a useful intervention for high-risk infants to reduce sensory and social delays. Further research is needed to identify the specific factors associated with adverse outcomes for infants. It is unclear whether infants are better or worse with sensory and social intervention. In practice, the choice of intervention will vary by circumstance. summary: Results from a recent paper is valuable because it allows clinicians to evaluate the effectiveness of sensory and social intervention for infants who are at risk for sensory and social delays.

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What are the common side effects of sensorimotor intervention?

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We developed a questionnaire (SSI) to measure parent perceptions. In a recent study, findings may provide a valid framework for future studies evaluating parent-led interventions to support infants at risk for neurodevelopmental delay and for use in pre-school assessments of infants at risk for language disorders and autism.

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Is sensorimotor intervention safe for people?

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People aged 12 months to 6 years and experiencing severe or multiple motor problems (e.g., flaccid muscle weakness, dysarthria) benefit from high-intensity sensorimotor training, which is well tolerated.

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