Patterned Experience for Preterm Infants (PEPI)

November 10, 2015 updated by: Children's Hospital Medical Center, Cincinnati
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Medical Center
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
  • 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Birth, Transition to by mouth feeding, hospital discharge, 2 mo corrected age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bailey Scale of Infant Development (BSID), 3rd edition
Time Frame: 6 and 24 months corrected age
Used as a measure of cognitive development.
6 and 24 months corrected age
Sucking activity
Time Frame: 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.
Changes from an average age of 33 weeks postmenstural age to an average age of 38 weeks postmenstural age.
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.
Used as a measure of autonomic system organization once oral feedings are initiated.
Changes from an average age of 33 weeks postmenstural age to an average age fo 38 weeks postmenstural age.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Rita H Pickler, PhD, RN, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 11, 2012

First Submitted That Met QC Criteria

April 13, 2012

First Posted (Estimate)

April 16, 2012

Study Record Updates

Last Update Posted (Estimate)

November 13, 2015

Last Update Submitted That Met QC Criteria

November 10, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01NR012307-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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