An interventional study of q6 hour oral feeding schedule and q3 hour oral feeding schedule in Infant, Premature, Diseases, Feeding Behavior and Feeding Patterns, sponsored by University of Pennsylvania. Completed at 2 sites in United States. Open to participants aged Up to 120 Days. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
Preterm infants face many feeding challenges during hospitalization which can prolong hospitalization, raise parental anxiety and can lead to medical instability. The Feeding Progression study will randomize preterm infants to one of two currently accepted oral feeding schedules; oral feed attempts every 3 hours or every 6 hours. The study will collect data on oral feeding success, milk transfer, sucking strength, growth and medical complications.
Preterm infants are at high risk for feeding issues. Feeding difficulties lead to prolonged hospitalization, increase medical complications and raise parental anxiety. The transition from tube feeding to oral feeding is an especially important step in a preterm infant's early life. Currently, there is limited evidence to guide this transition. There are two commonly used schedules for transitioning preterm infants to oral feeding: an every 6 hour schedule and an every 3 hour schedule. However, there is currently no evidence to guide providers in their choice of oral feeding schedule.
The primary objective of this study is to explore whether an every 6 (q6) hour oral feeding schedule will improve time to full oral feedings as compared to an every 3 (q3) hour oral feeding schedule. The secondary objectives are to test whether every 6 hour feeding allows for improved medical stability and oral-motor coordination as compared to the other commonly used q3 hour schedule. Each infant will be randomly assigned to a q6 hour or q3 hour oral feeding schedule. Data on oral feeding progression, respiratory status and oral motor proficiency will be collected and compared. The study will collect data on how long it takes each infant to get to full oral feeds, respiratory status throughout their time of oral feeding, whether there were any episodes of medical complications, measures of oral motor feeding skills, and the time to discharge from the hospital. This study is a crucial first step towards determining which feeding schedule is optimal for preterm infants to ensure timely attainment of full oral feeds and hospital discharge without compromising medical stability.
100 studies on the registry are indexed under Infant, Premature, Diseases; 16 are open to participants now.
This study's enrollment of 55 is below the median of 62 across 64 interventional studies indexed under Infant, Premature, Diseases.
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Exclusion Criteria:
Infants in this arm will be offered oral feedings every 6 hours if they are safe and ready to feed by mouth.
Other: q6 hour oral feeding schedule
Infants in this arm will be offered oral feedings every 3 hours if they are safe and ready to feed by mouth.
Other: q3 hour oral feeding schedule
The intervention is the schedule under which stable infants are offered oral feeding attempts: every 6 hours.
The intervention is the schedule under which stable infants are offered oral feeding attempts: every 3 hours.
Time to full oral feeds
Assess the relationship between feeding schedule and time to reach full oral feeds in preterm infants.
Time frame: 38 weeks gestation on average
Time to discharge
Assess the relationship between feeding schedule and overall length of hospitalization.
Time frame: 40 weeks gestation on average
Medical Complications
Explore the relationship between feeding schedule and medical complications including apnea of prematurity, bronchopulmonary dysplasia, episodes of suspected sepsis, feeding intolerance and physiologic instability during the time of oral feeds.
Time frame: 38 weeks gestation on average
Growth
Assess the growth during the period of time from initiation of oral feeds to reaching complete oral feeds.
Time frame: 40 weeks gestation on average
Feeding skills
Assess feeding competence and sucking skills from initiation of feeds through discharge on full oral feeds.
Time frame: 40 weeks gestation on average
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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