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Patterned Experience for Preterm Infants (PEPI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01577615
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Description
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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.

Condition or disease Intervention/treatment Phase
Complication of Prematurity Behavioral: Patterned Experience Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patterned Experience for Preterm Infants
Study Start Date : February 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Bailey Scale of Infant Development (BSID), 3rd edition [ Time Frame: 6 and 24 months corrected age ]
    Used as a measure of cognitive development.

  2. 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.

  3. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577615


Locations
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United States, Ohio
University of Cincinnati Health Center
Cincinnati, Ohio, United States, 45219
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Rita H Pickler, PhD, RN Children's Hospital Medical Center, Cincinnati
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01577615    
Other Study ID Numbers: R01NR012307-02 ( U.S. NIH Grant/Contract )
First Posted: April 16, 2012    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Preterm Infant
Neurobehavioral
Development
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
 Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases