Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit

Launched by SHIRLEY RYAN ABILITYLAB · Sep 30, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how a special physical therapy program can help improve movement skills in infants who have been admitted to the Neonatal Intensive Care Unit (NICU). The study specifically aims to see if starting therapy early, from the time they leave the NICU until they reach 12 months of age, can help these babies develop better motor skills and reduce any delays in their movements. Researchers believe that babies who receive this therapy will show significant improvement compared to those who only receive standard care.

To be eligible for this trial, infants must have been in the NICU and meet certain health criteria, such as being born prematurely or having specific brain or lung conditions. If parents agree for their baby to participate, they can expect to be part of a program designed to support both the baby's development and the well-being of the caregivers. The study is currently recruiting participants and is focused on providing tailored support to families, aiming to enhance their overall experience during this critical time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• NICU admission and qualifies for Early Childhood Clinic (NICU high-risk follow up clinic) or Early Intervention due to:
• • BW \<1500 grams
• • OR
• • Disorders of the central nervous system
• • Brain injury (including but not limited to extra axial hemorrhage, any grade intraventricular or intraparenchymal hemorrhage, stroke, hypoxic ischemic encephalopathy (HIE), meningitis)
• • HIE includes mild, moderate, severe exam on modified Sarnat exam, both cooled and non-cooled
• • includes "at risk for HIE" with 10-minute Apgar \<7 plus pH\<7.15 or base deficit \>/=12.
• • Brain developmental abnormalities (hydrocephalus, microcephaly, cortical dysgenesis)
• • Cramped synchronous movements at term PMA
• • OR
• • Bronchopulmonary dysplasia (BPD) defined as need for respiratory support at 36 weeks postmenstrual age in an infant born at \<32 weeks of gestation.
• • AND
• • Medically stable AND able to start intervention between 34-48 weeks PMA.
• Exclusion Criteria:
• • (related to inability to complete intervention, sensor placement, or clinic assessments)
• • open wounds, skin condition precluding sensor placement
• • immune deficiencies requiring protective isolation
• • limb reduction defects
• • followed primarily in another clinic (including but not limited to meningomyelocele and related conditions/trisomy 21)
• • bleeding disorders or ongoing need for anticoagulation
• • palliative or hospice care (for life limiting conditions including, but not limited to trisomy 18, 13)
• • known visual impairment at the time of enrollment
• • DCFS custody
• • no English-speaking caregivers
• • any other condition that would preclude participation in the study, as determined by the PI
• • previously enrolled in competing randomized trial with developmental outcome variables
• • Each child's enrollment in the study will be approved by the child's neonatologist.