NCT01577615

Patterned Experience for Preterm Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 32 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Complication of Prematurity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-02-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2012-04-16
• Last updated: 2015-11-13

Locations

2 sites across 1 country: United States