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Patterned Experience for Preterm Infants

NCT01577615 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2015-11-13

No results posted yet for this study

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.

Conditions

  • Complication of Prematurity

Interventions

BEHAVIORAL

Patterned 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 & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Rita H Pickler, PhD, RN · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01577615 on ClinicalTrials.gov