Feeding Progression in Preterm Infants
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|ClinicalTrials.gov Identifier: NCT02027688|
Recruitment Status : Completed
First Posted : January 6, 2014
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Infant, Premature, Diseases Feeding Behavior Feeding Patterns||Other: q6 hour oral feeding schedule Other: q3 hour oral feeding schedule||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feeding Progression in Preterm Infants|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Active Comparator: Every 6 hour Feeding Schedule
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
The intervention is the schedule under which stable infants are offered oral feeding attempts: every 6 hours.
Active Comparator: Every 3 Hour Oral Feeding
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 3 hours.
- Time to full oral feeds [ Time Frame: 38 weeks gestation on average ]Assess the relationship between feeding schedule and time to reach full oral feeds in preterm infants.
- Time to discharge [ Time Frame: 40 weeks gestation on average ]Assess the relationship between feeding schedule and overall length of hospitalization.
- Medical Complications [ Time Frame: 38 weeks gestation on average ]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.
- Growth [ Time Frame: 40 weeks gestation on average ]Assess the growth during the period of time from initiation of oral feeds to reaching complete oral feeds.
- Feeding skills [ Time Frame: 40 weeks gestation on average ]Assess feeding competence and sucking skills from initiation of feeds through discharge on full oral feeds.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027688
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Sara B DeMauro, MD, MSCE||Children's Hospital of Philadelphia|