Patterned Experience for Preterm Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 121
- Locations
- 4
- Primary Endpoint
- Neurobehavioral Assessment of the Preterm Infant (NAPI)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 32 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Infants born ≤ 32 weeks gestation
Exclusion Criteria
- •Infants will be excluded if the infant has gastrointestinal, craniofacial, cardiovascular, neuromuscular, and/or genetic defects
Outcomes
Primary Outcomes
Neurobehavioral Assessment of the Preterm Infant (NAPI)
Time Frame: Birth, Transition to by mouth feeding, hospital discharge, 2 mo corrected age
Used as a measure of neurobehavioral development.
Secondary Outcomes
- Sucking activity(Changes from an average age of 33 weeks postmenstural age to an average age of 38 weeks postmenstural age.)
- Bailey Scale of Infant Development (BSID), 3rd edition(6 and 24 months corrected age)
- Heart rate variability (low frequency:high frequency ratio)(Changes from an average age of 33 weeks postmenstural age to an average age fo 38 weeks postmenstural age.)