Premature InfantNCT03836326
A Parent Administered Sensorimotor Intervention and Developmental Outcome of Preterm Infants
A study testing Sensorimotor intervention and Story telling attention refocusing intervention in people with Premature Infant and Developmental Delay, run by Dr. Sandra Fucile at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 34 weeks
- Conditions the study is for
- Premature Infant, Developmental Delay
- What is being tested?
- Sensorimotor intervention and Story telling attention refocusing intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2019to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born < 34 weeks gestation
- Infants whose parent (s) intend on visiting regularly (> 5 days)
Who cannot join
- Infants born with a metabolic disorder or congenital abnormality
- Infants whose parents are unable to participate due to cognitive, physical or social issues.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developmental Outcome of Preterm Infants Enrolled in a Randomized Clinical of a Parent Administered Sensorimotor Intervention in the Neonatal Intensive Care Unit
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.
Read the detailed 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.
- Conditions
- Premature Infant, Developmental Delay
- Being tested
- Sensorimotor intervention, Control, Story telling attention refocusing intervention
- Keywords
- Prematurity, Development, Parental engagement, Parental satisfaction
- Medical subject headings
- Premature Birth, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensorimotor interventionOther
Also called Supplemental stimulation, Sensory input, Tactile input, Oral input
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.
ControlOther
Routine care provided by health professionals in the NICU
Story telling attention refocusing interventionOther
Also called STAR
A contact-free intervention where parents share stories with their infant for 10 minutes 3 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Sensorimotor intervention | Experimental | 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. Receives: Other: Sensorimotor intervention; Other: Story telling attention refocusing intervention |
| Control | Other | Infants in the control group will receive standard care only. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attainment of independent oral feeds
Number of days to transition from complete tube to complete oral feeds.
Measured: 3 years
Secondary outcomes (4)
Weight gain
Weight gain velocity from start of study until hospital discharge
Measured: 3 years
Length of hospital stay
Number of days from birth to discharge home
Measured: 3 years
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.
Measured: 3 years
Acute stress of parents
The PSS: NICU assessment was used to assess acute stress of parents
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start1 Jul 2019
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized clinical trail
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Sandra Fucile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Sandra Fucile, Queen's University
- Investigators
- Sandra Fucile, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836326
- Sponsor's protocol ID
- 6023834
- Status last verified
- May 2024
- First submitted
- 6 Feb 2019
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Outcome of Preterm Infants Enrolled in a Randomized Clinical of a Parent Administered Sensorimotor Intervention in the Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03836326
- Acronym / sponsor ID
- 6023834
- Conditions
- Premature Infant, Developmental Delay
- Keywords
- Prematurity, Development, Parental engagement, Parental satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Dr. Sandra FucileUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trail
| Arm | Type | Receives |
|---|---|---|
| Sensorimotor intervention | Experimental | Other: Sensorimotor intervention, Other: Story telling attention refocusing interventionIs 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. |
| Control | Other | Other: ControlInfants in the control group will receive standard care only. |
Who may qualify
- Ages
- Up to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants born < 34 weeks gestation
- Infants whose parent (s) intend on visiting regularly (> 5 days)
Key exclusion criteria (2 listed)
- Infants born with a metabolic disorder or congenital abnormality
- Infants whose parents are unable to participate due to cognitive, physical or social issues.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensorimotor interventionAlso: Supplemental stimulation, Sensory input, Tactile input, Oral inputSensorimotor 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 | Sensorimotor intervention |
| ControlRoutine care provided by health professionals in the NICU | Other | Control |
| Story telling attention refocusing interventionAlso: STARA contact-free intervention where parents share stories with their infant for 10 minutes 3 times per week. | Other | Sensorimotor intervention |
Primary outcome
Attainment of independent oral feeds
Time frame: 3 years
Number of days to transition from complete tube to complete oral feeds.
4 secondary outcomes
Weight gain
Time frame: 3 years
Length of hospital stay
Time frame: 3 years
Test of infant motor performance
Time frame: 3 years
Acute stress of parents
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Fucile, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensorimotor intervention and Story telling attention refocusing intervention in people with Premature Infant and Developmental Delay, run by Dr. Sandra Fucile at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attainment of independent oral feeds (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.