NEO Rehab for Infants at Risk of Cerebral Palsy
Completed · Not applicable
Conditions studied: Prematurity, Cerebral Palsy
In brief
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.
Key facts
- Study ID
- NCT03372590
- Run by
- University of Virginia
- People needed
- 14
- Starts
- 2018-09-02
- Expected to finish
- 2019-06-30
- Last updated by the study team
- 2020-04-03
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Infant Gestational age <32 weeks AND/OR birth weight <1500g
You may not qualify if…
- 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
Where it is running
- University of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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