Patterned Experience for Preterm Infants

Complication of Prematurity Clinical Trial

— PEPI  

Official title:

Patterned Experience for Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577615
• Other study ID #: R01NR012307-02
• Status: Completed
• Phase: N/A
• First received: April 11, 2012
• Last updated: November 10, 2015
• Start date: February 2012
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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 neurobehavioral and cognitive function while at the same time being cost effective in its delivery.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 32 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complication of Prematurity

Intervention

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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Medical Center	Cincinnati	Ohio
United States	University of Cincinnati Health Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Bailey Scale of Infant Development (BSID), 3rd edition	Used as a measure of cognitive development.	6 and 24 months corrected age	No
Secondary	Sucking activity	Used as a measure of central nervous system organization once oral feeding is initiated.	Changes from an average age of 33 weeks postmenstural age to an average age of 38 weeks postmenstural age.	No
Secondary	Heart rate variability (low frequency:high frequency ratio)	Used as a measure of autonomic system organization once oral feedings are initiated.	Changes from an average age of 33 weeks postmenstural age to an average age fo 38 weeks postmenstural age.	No