Complication of Prematurity Clinical Trial
Official title:
Patterned Experience for Preterm Infants
The PEPI study is designed to provide a patterned feeding experience. By using a regularly occurring and necessary caregiving event, feeding, as the vehicle for the patterned experience, the intervention should be effective at promoting and reinforcing neuronal growth and connections that are critical for neurobehavioral and cognitive function while at the same time being cost effective in its delivery.
Infants will be randomly assigned to a study group or control group. The research study will
last for approximately twenty four months. Infants will have daily assessments while in the
hospital and three study visits after hospital discharge. All post-discharge visits will
occur in an out patient hospital setting. During the first days of life, study staff will
start observing infant's development by using assessment tools. Lab samples include one
blood sample taken when other blood is being collected in the first days of life and one
saliva sample when the infants starts bottle feeding.
When tube feedings are started in the study group, caregivers (nurses, parents or research
staff) will gently place hands on the infant while in the incubator (ill babies) or bundled
outside the incubator. If the infant is in the control group, they will receive standard
tube feeding care.
When oral feedings are started in the study group, the infant will have an opportunity at
every feeding to be breast or bottle fed while being held. If unable to complete the entire
feeding orally, the rest will be tube fed.
If the infant is in the control group, feeding opportunities will be decided by the medical
team providing care.
All infants will be observed during oral feedings twice a week while in the hospital. Study
staff will watch heart rate, sucking activity (a sensor on the chin) and level of
wakefulness.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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