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NEO Rehab for Infants at Risk of Cerebral Palsy

NEO Rehabilitation Program for Premature Infants at Risk for Cerebral Palsy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03372590
Enrollment
14
Registered
2017-12-13
Start date
2018-09-02
Completion date
2019-06-30
Last updated
2020-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Prematurity

Keywords

general movement assessment

Brief 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. 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: 1. To determine the proportion of infants (\<32 weeks gestation and/or \<1500g) who have abnormal GMs findings using the GMA tool. 2. 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. 3. 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.

Interventions

OTHERNICU-based rehabilitation bundle

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

OTHERStandard of care

Standard NICU care

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 33 Weeks
Healthy volunteers
No

Inclusion criteria

* Infant Gestational age \<32 weeks AND/OR birth weight \<1500g

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
NICU-based rehabilitation program feasibility2 yearsThe 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

Secondary

MeasureTime frameDescription
Evolution of GMA patterns in high risk infants2 yearsGME will be scored on enrollment and at NICU discharge
Impact on maternal stress and depression2 yearsAssessed on enrollment and NICU discharge using the PSS-NICU and PROMIS instrument

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026