Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
121 participants
INTERVENTIONAL
2012-02-29
2015-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
32 Weeks
ALL
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Rita H Pickler, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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University of Cincinnati Health Center
Cincinnati, Ohio, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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