Clinical trial NCT01577615: Patterned Experience for Preterm Infants
Official title: Patterned Experience for Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complication of Prematurity
Keywords: Preterm Infant
Neurobehavioral
Development
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2012-04-16
Enrollment: 121
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Neurobehavioral Assessment of the Preterm Infant (NAPI)
timeFrame: Birth, Transition to by mouth feeding, hospital discharge, 2 mo corrected age
Secondary outcomes:
measure: Bailey Scale of Infant Development (BSID), 3rd edition
timeFrame: 6 and 24 months corrected age
measure: Sucking activity
timeFrame: Changes from an average age of 33 weeks postmenstural age to an average age of 38 weeks postmenstural age.
measure: Heart rate variability (low frequency:high frequency ratio)
timeFrame: Changes from an average age of 33 weeks postmenstural age to an average age fo 38 weeks postmenstural age.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Health Center
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Rita H Pickler, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.