CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 121 enrolled
Drug / intervention
Patterned Experiencebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01577615
NCT01577615N/ACompleted

Patterned Experience for Preterm Infants

Children's Hospital Medical Center, Cincinnati·interventional·Posted Apr 16, 2012·Updated Nov 13, 2015

In Brief

A clinical study evaluating Patterned Experience for Complication of Prematurity. Completed, enrolled 121 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 16, 2012
Enrollment StartFeb 1, 2012
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 14.2 years ago

Interventions

Patterned Experiencebehavioral

* 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.