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Complication of PrematurityPEPINCT01577615

Patterned Experience for Preterm Infants

A study testing Patterned Experience in people with Complication of Prematurity, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 32 weeks
Conditions the study is for
Complication of Prematurity
What is being tested?
Patterned Experience
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
2 sitesUnited States
Study dates
Feb 2012to Sep 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 32 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Infants born ≤ 32 weeks gestation

Who cannot join

  • Infants will be excluded if the infant has gastrointestinal, craniofacial, cardiovascular, neuromuscular, and/or genetic defects

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Cincinnati Health Center

    Cincinnati, Ohio, 45219

  • Cincinnati Children's Medical Center

    Cincinnati, Ohio, 45229

Other trials in United States

About this study

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.

Read the 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.

Being tested
Patterned Experience
Keywords
Preterm Infant, Neurobehavioral, Development
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patterned ExperienceBehavioural

    • 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.
Study groups in NCT01577615
Study groupRoleWhat they receive
Patterned Experience GroupExperimentalInfants 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.
Receives: Behavioral: Patterned Experience
Usual Care GroupNo interventionIn 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurobehavioral Assessment of the Preterm Infant (NAPI)

    Used as a measure of neurobehavioral development.

    Measured: Birth, Transition to by mouth feeding, hospital discharge, 2 mo corrected age

Secondary outcomes (3)

  1. Bailey Scale of Infant Development (BSID), 3rd edition

    Used as a measure of cognitive development.

    Measured: 6 and 24 months corrected age

  2. Sucking activity

    Used as a measure of central nervous system organization once oral feeding is initiated.

    Measured: Changes from an average age of 33 weeks postmenstural age to an average age of 38 weeks postmenstural age.

  3. Heart rate variability (low frequency:high frequency ratio)

    Used as a measure of autonomic system organization once oral feedings are initiated.

    Measured: Changes from an average age of 33 weeks postmenstural age to an average age fo 38 weeks postmenstural age.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01577615
Sponsor's protocol ID
R01NR012307-02
Acronym
PEPI
Status last verified
Nov 2015
First submitted
11 Apr 2012
Last updated
13 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Pickler RH, Meinzen-Derr J, Moore M, Sealschott S, Tepe K. Effect of Tactile Experience During Preterm Infant Feeding on Clinical Outcomes. Nurs Res. 2020 Sep/Oct;69(5S Suppl 1):S21-S28. doi: 10.1097/NNR.0000000000000453.

    PubMed 32555011

  • Nist MD, Shoben AB, Pickler RH. Early Inflammatory Measures and Neurodevelopmental Outcomes in Preterm Infants. Nurs Res. 2020 Sep/Oct;69(5S Suppl 1):S11-S20. doi: 10.1097/NNR.0000000000000448.

    PubMed 32496397

  • Pickler R, Sealschott S, Moore M, Merhar S, Tkach J, Salzwedel AP, Lin W, Gao W. Using Functional Connectivity Magnetic Resonance Imaging to Measure Brain Connectivity in Preterm Infants. Nurs Res. 2017 Nov/Dec;66(6):490-495. doi: 10.1097/NNR.0000000000000241.

    PubMed 29095379

  • Pickler RH, Wetzel PA, Meinzen-Derr J, Tubbs-Cooley HL, Moore M. Patterned feeding experience for preterm infants: study protocol for a randomized controlled trial. Trials. 2015 Jun 4;16:255. doi: 10.1186/s13063-015-0781-3.

    PubMed 26041365

Questions about this trial

What is this clinical trial studying?

A study testing Patterned Experience in people with Complication of Prematurity, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurobehavioral Assessment of the Preterm Infant (NAPI) (time frame: Birth, Transition to by mouth feeding, hospital discharge, 2 mo corrected age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01577615, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015.

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