Complication of Prematurity
Conditions
Keywords
Preterm Infant, Neurobehavioral, Development
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.
Interventions
BEHAVIORALPatterned Experience
* The caregiver's hand over the shoulder area and the other hand over the lower extremities during feeding in the incubator, swaddling or holding outside the incubator. * Nonnutritive sucking will be offered to infants. * Blood work will be collected for inflammatory cytokines. * Saliva will be collected for genetic analysis * Saliva will be collected in 10 infant sub study for cortisol pre and post feedings * All scheduled feedings will include an opportunity for the infant to try feeding orally by bottle or breast while being held in a swaddled flexed position. * Once bottle feedings are initiated, infants will be observed twice a week utilizing the computer data acquisition system. * Follow up visits will occur at 2,6and 24 months corrected age.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 32 Weeks
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurobehavioral Assessment of the Preterm Infant (NAPI) | Birth, Transition to by mouth feeding, hospital discharge, 2 mo corrected age | Used as a measure of neurobehavioral development. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bailey Scale of Infant Development (BSID), 3rd edition | 6 and 24 months corrected age | Used as a measure of cognitive development. |
| Sucking activity | Changes from an average age of 33 weeks postmenstural age to an average age of 38 weeks postmenstural age. | Used as a measure of central nervous system organization once oral feeding is initiated. |
| 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. | Used as a measure of autonomic system organization once oral feedings are initiated. |
Countries
United States
Outcome results
None listed