Patterned Experience for Preterm Infants

NCT01577615 | Completed DMC

• 1 other identifier: R01NR012307-02
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 2

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.

Conditions

Complication of Prematurity

Keywords

Preterm Infant; Neurobehavioral; Development

Outcome Measures

Primary Outcomes (1)

• Neurobehavioral Assessment of the Preterm Infant (NAPI)

  Used as a measure of neurobehavioral development.

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

Secondary Outcomes (3)

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

  6 and 24 months corrected age

• Sucking activity

  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)

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

Study Arms (2)

Patterned Experience Group

EXPERIMENTAL

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

Usual Care Group

NO INTERVENTION

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.

Interventions

Patterned Experience BEHAVIORAL

* 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.

Patterned Experience Group

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born ≤ 32 weeks gestation

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (2)

University of Cincinnati Health Center

Cincinnati, Ohio, 45219, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (4)

• 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.

  PMID: 32555011 DERIVED

• 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.

  PMID: 32496397 DERIVED

• 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.

  PMID: 29095379 DERIVED

• 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.

  PMID: 26041365 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Rita H Pickler, PhD, RN

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 16, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 13, 2015

Record last verified: 2015-11

Locations

US (2)