Patterned Experience for Preterm Infants (PEPI)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Patterned Experience for Preterm Infants|
- Neurobehavioral Assessment of the Preterm Infant (NAPI) [ Time Frame: Birth, Transition to by mouth feeding, hospital discharge, 2 mo corrected age ] [ Designated as safety issue: No ]Used as a measure of neurobehavioral development.
- Bailey Scale of Infant Development (BSID), 3rd edition [ Time Frame: 6 and 24 months corrected age ] [ Designated as safety issue: No ]Used as a measure of cognitive development.
- Sucking activity [ Time Frame: Changes from an average age of 33 weeks postmenstural age to an average age of 38 weeks postmenstural age. ] [ Designated as safety issue: No ]Used as a measure of central nervous system organization once oral feeding is initiated.
- Heart rate variability (low frequency:high frequency ratio) [ Time Frame: Changes from an average age of 33 weeks postmenstural age to an average age fo 38 weeks postmenstural age. ] [ Designated as safety issue: No ]Used as a measure of autonomic system organization once oral feedings are initiated.
|Study Start Date:||February 2012|
|Study Completion Date:||September 2015|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: Patterned Experience Group
Infants in the patterned experience group will receive a patterned feeding experience with all feedings through discharge. They will receive a touch intervention at each gavage feeding. Once oral feedings are initiated, they will be offered an oral feeding at every scheduled feeding. They will be held for feedings. They will be observed twice a week utilizing the computer data acquisition system. Follow up visits will occur at 2,6 amd 24 months corrected age.
Behavioral: Patterned Experience
No Intervention: Usual Care Group
In the usual care group infants usually are not held or contained during gavage feeding. Infants in the usual care group are orally fed at the discretion of the nurses or medical team. Once oral feedings are initiated, infants will be observed twice a week using the computer data acquisition system. Follow up visits will occur at 2,6 and 24 months corrected age.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577615
|United States, Ohio|
|Cincinnati Children's Medical Center|
|Cincinnati, Ohio, United States, 45229|
|University of Cincinnati Health Center|
|Cincinnati, Ohio, United States, 45219|
|Principal Investigator:||Rita H Pickler, PhD, RN||Children's Hospital Medical Center, Cincinnati|