PrematurityNCT03372590
NEO Rehab for Infants at Risk of Cerebral Palsy
A study testing NICU-based rehabilitation bundle in people with Prematurity and Cerebral Palsy, run by University of Virginia at 1 site in United States.
Trial summary
Premature infants are at increased risk of developing cerebral palsy (CP). Early interventions for at risk infants have the potential to decrease disease severity and improve quality of life. Read more about this study
- Who is it for?
- Ages Up to 33 weeks
- Conditions the study is for
- Prematurity, Cerebral Palsy
- What is being tested?
- NICU-based rehabilitation bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2018to 30 Jun 2019
- 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 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant Gestational age <32 weeks AND/OR birth weight <1500g
Who cannot join
- Any clinical condition / diagnosis that would restrict the ability of the mother to do Kangaroo Care per the current UVA Kangaroo Care guideline
- Non-English-speaking mother
- Mother is a prisoner
- Confirmed inability to return for follow-up appointment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: NEO Rehabilitation Program for Premature Infants at Risk for Cerebral Palsy
Premature infants are at increased risk of developing cerebral palsy (CP). Early interventions for at risk infants have the potential to decrease disease severity and improve quality of life. All infants demonstrate general movements (GMs), which are reliable indicators of brain function and can be reproducibly evaluated using the General Movement Assessment (GMA) tool.
Prior studies have demonstrated the impact of early maternal-driven intervention strategies on neurodevelopmental outcomes in preterm infants. Investigators have shown that interventions promoting the establishment of emotional connection between the infant and his or her mother, including mother/infant calming sessions with scent cloth exchange, vocal soothing, eye contact, and kangaroo care, can impact neurodevelopmental outcomes at 18 months. Investigators have also shown that 60 minutes of kangaroo care leads to decreasing levels of the stress hormone cortisol in both mothers and infants.
This pilot study aims to determine the feasibility of a maternal-driven early intervention bundle in preterm infants with abnormal GMA.
Read the detailed description
The study objective are 3-fold:
- To determine the proportion of infants (<32 weeks gestation and/or <1500g) who have abnormal GMs findings using the GMA tool.
- To determine the feasibility of NICU based rehabilitation program in 20 infants determined to be at high risk for CP using the GMA tool. The intervention bundle will consist of a maternal-driven gestational age (GA)-appropriate intervention bundle that will include evidence-based interventions including vocal soothing, comforting touch, scent exchange, kangaroo care, and infant massage. Patients will be compared to contemporary and GA-matched controls receiving standard of care with a 1:2 assignment.
- To evaluate the short-term impact of a maternal-driven intervention bundle on the mother-infant dyad. Maternal stress will be measured using the Parental Stress Scale for NICU patients (PSS: NICU) prior to the intervention and prior to the infant's NICU discharge. Further, stress will be assessed by measuring maternal and infant salivary cortisol pre-and post-kangaroo care on 3 separate occasions (post enrollment in the study, mid-hospital stay, and prior to discharge). Measures of maternal anxiety and depression will be evaluated prior to the intervention and prior to NICU discharge using the Patient Reported Outcomes Measurement Information System (PROMIS) instrument.
The investigators hypothesize that the intervention will lead to positive and measurable outcomes for the mother-infant dyad.
- Conditions
- Prematurity, Cerebral Palsy
- Being tested
- NICU-based rehabilitation bundle, Standard of care
- Keywords
- general movement assessment
- Medical subject headings
- Premature Birth, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NICU-based rehabilitation bundleOther
Also called scent exchange, kangaroo care, massage, vocal soothing
Maternal-driven gestational age-appropriate intervention/activity bundle, including the evidence-based elements of vocal soothing, comforting touch, scent exchange, kangaroo care, and infant massage
Standard of careOther
Standard NICU care
| Study group | Role | What they receive |
|---|---|---|
| NICU-based rehabilitation bundle | Experimental | Patients identified to be at high risk for cerebral palsy will be enrolled after parental consent is obtained to the NICU rehabilitation program. This program consists of maternal-driven evidence based intervention that include: vocal soothing, scent exchange, comforting touch, kangaroo care, and infant massage. These intervention will be provided at GA-appropriate intervals. Receives: Other: NICU-based rehabilitation bundle |
| Standard of care | Other | Infants not participating in the intervention study will be provided with standard or care. Interventions include kangaroo care, physical therapy and infant massage provided by NICU staff. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
NICU-based rehabilitation program feasibility
The feasibility of a maternal driven intervention bundle will be assessed using a maternal diary and unannounced observations. The ability to perform the required intervention greater than 75% of the time will be considered successful
Measured: 2 years
Secondary outcomes (2)
Evolution of GMA patterns in high risk infants
GME will be scored on enrollment and at NICU discharge
Measured: 2 years
Impact on maternal stress and depression
Assessed on enrollment and NICU discharge using the PSS-NICU and PROMIS instrument
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start2 Sep 2018
- Primary completion24 Apr 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santina Zanelli, University of Virginia
- Investigators
- Santina A Zanelli, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372590
- Sponsor's protocol ID
- 20318
- Status last verified
- Apr 2020
- First submitted
- 8 Dec 2017
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEO Rehabilitation Program for Premature Infants at Risk for Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03372590
- Acronym / sponsor ID
- 20318
- Conditions
- Prematurity, Cerebral Palsy
- Keywords
- general movement assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 2 Sep 2018 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 13 Dec 2017 (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.
Premature infants are at increased risk of developing cerebral palsy (CP). Early interventions for at risk infants have the potential to decrease disease severity and improve quality of life. All infants demonstrate general movements (GMs), which are reliable indicators of brain function and can be reproducibly evaluated using the General Movement Assessment (GMA) tool.
Prior studies have demonstrated the impact of early maternal-driven intervention strategies on neurodevelopmental outcomes in preterm infants. Investigators have shown that interventions promoting the establishment of emotional connection between the infant and his or her mother, including mother/infant calming sessions with scent cloth exchange, vocal soothing, eye contact, and kangaroo care, can impact neurodevelopmental outcomes at 18 months. Investigators have also shown that 60 minutes of kangaroo care leads to decreasing levels of the stress hormone cortisol in both mothers and infants.
This pilot study aims to determine the feasibility of a maternal-driven early intervention bundle in preterm infants with abnormal GMA.
Detailed description
The study objective are 3-fold:
- To determine the proportion of infants (<32 weeks gestation and/or <1500g) who have abnormal GMs findings using the GMA tool.
- To determine the feasibility of NICU based rehabilitation program in 20 infants determined to be at high risk for CP using the GMA tool. The intervention bundle will consist of a maternal-driven gestational age (GA)-appropriate intervention bundle that will include evidence-based interventions including vocal soothing, comforting touch, scent exchange, kangaroo care, and infant massage. Patients will be compared to contemporary and GA-matched controls receiving standard of care with a 1:2 assignment.
- To evaluate the short-term impact of a maternal-driven intervention bundle on the mother-infant dyad. Maternal stress will be measured using the Parental Stress Scale for NICU patients (PSS: NICU) prior to the intervention and prior to the infant's NICU discharge. Further, stress will be assessed by measuring maternal and infant salivary cortisol pre-and post-kangaroo care on 3 separate occasions (post enrollment in the study, mid-hospital stay, and prior to discharge). Measures of maternal anxiety and depression will be evaluated prior to the intervention and prior to NICU discharge using the Patient Reported Outcomes Measurement Information System (PROMIS) instrument.
The investigators hypothesize that the intervention will lead to positive and measurable outcomes for the mother-infant dyad.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NICU-based rehabilitation bundle | Experimental | Other: NICU-based rehabilitation bundlePatients identified to be at high risk for cerebral palsy will be enrolled after parental consent is obtained to the NICU rehabilitation program. This program consists of maternal-driven evidence based intervention that include: vocal soothing, scent exchange, comforting touch, kangaroo care, and infant massage. These intervention will be provided at GA-appropriate intervals. |
| Standard of care | Other | Other: Standard of careInfants not participating in the intervention study will be provided with standard or care. Interventions include kangaroo care, physical therapy and infant massage provided by NICU staff. |
Who may qualify
- Ages
- Up to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infant Gestational age <32 weeks AND/OR birth weight <1500g
Key exclusion criteria (4 listed)
- Any clinical condition / diagnosis that would restrict the ability of the mother to do Kangaroo Care per the current UVA Kangaroo Care guideline
- Non-English-speaking mother
- Mother is a prisoner
- Confirmed inability to return for follow-up appointment
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 |
|---|---|---|
| NICU-based rehabilitation bundleAlso: scent exchange, kangaroo care, massage, vocal soothingMaternal-driven gestational age-appropriate intervention/activity bundle, including the evidence-based elements of vocal soothing, comforting touch, scent exchange, kangaroo care, and infant massage | Other | NICU-based rehabilitation bundle |
| Standard of careStandard NICU care | Other | Standard of care |
Primary outcome
NICU-based rehabilitation program feasibility
Time frame: 2 years
The feasibility of a maternal driven intervention bundle will be assessed using a maternal diary and unannounced observations. The ability to perform the required intervention greater than 75% of the time will be considered successful
2 secondary outcomes
Evolution of GMA patterns in high risk infants
Time frame: 2 years
Impact on maternal stress and depression
Time frame: 2 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 3 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Santina A Zanelli, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NICU-based rehabilitation bundle in people with Prematurity and Cerebral Palsy, run by University of Virginia at 1 site in United States.
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 1 inclusion and 4 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 3 Apr 2020. 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 United States. 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?
NICU-based rehabilitation program feasibility (time frame: 2 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 3 Apr 2020.