Feeding Progression in Preterm Infants
Primary Purpose
Infant, Premature, Diseases, Feeding Behavior, Feeding Patterns
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
q6 hour oral feeding schedule
q3 hour oral feeding schedule
Sponsored by
About this trial
This is an interventional treatment trial for Infant, Premature, Diseases focused on measuring Oral feeding, Premature, Infants, Neonatal Intensive Care Unit
Eligibility Criteria
Inclusion Criteria:
- Gestational age between 23 0/7-33 0/7 weeks
- Eligible for oral (PO) feeding as determined by the attending Neonatologist
Exclusion Criteria:
- Infants with major congenital malformations
- Infants with chromosomal defects
- Diagnosis of Neonatal Abstinence Syndrome or opiate withdrawal
- Grade 3 or 4 Intraventricular Hemorrhage
Sites / Locations
- Hospital of the University of Pennsylvania
- Pennsylvania Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Every 6 hour Feeding Schedule
Every 3 Hour Oral Feeding
Arm Description
Infants in this arm will be offered oral feedings every 6 hours if they are safe and ready to feed by mouth.
Infants in this arm will be offered oral feedings every 3 hours if they are safe and ready to feed by mouth.
Outcomes
Primary Outcome Measures
Time to full oral feeds
Assess the relationship between feeding schedule and time to reach full oral feeds in preterm infants.
Secondary Outcome Measures
Time to discharge
Assess the relationship between feeding schedule and overall length of hospitalization.
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.
Growth
Assess the growth during the period of time from initiation of oral feeds to reaching complete oral feeds.
Feeding skills
Assess feeding competence and sucking skills from initiation of feeds through discharge on full oral feeds.
Full Information
NCT ID
NCT02027688
First Posted
December 31, 2013
Last Updated
December 1, 2015
Sponsor
University of Pennsylvania
Collaborators
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT02027688
Brief Title
Feeding Progression in Preterm Infants
Official Title
Feeding Progression in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
Children's Hospital of Philadelphia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases, Feeding Behavior, Feeding Patterns
Keywords
Oral feeding, Premature, Infants, Neonatal Intensive Care Unit
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Every 6 hour Feeding Schedule
Arm Type
Active Comparator
Arm Description
Infants in this arm will be offered oral feedings every 6 hours if they are safe and ready to feed by mouth.
Arm Title
Every 3 Hour Oral Feeding
Arm Type
Active Comparator
Arm Description
Infants in this arm will be offered oral feedings every 3 hours if they are safe and ready to feed by mouth.
Intervention Type
Other
Intervention Name(s)
q6 hour oral feeding schedule
Intervention Description
The intervention is the schedule under which stable infants are offered oral feeding attempts: every 6 hours.
Intervention Type
Other
Intervention Name(s)
q3 hour oral feeding schedule
Intervention Description
The intervention is the schedule under which stable infants are offered oral feeding attempts: every 3 hours.
Primary Outcome Measure Information:
Title
Time to full oral feeds
Description
Assess the relationship between feeding schedule and time to reach full oral feeds in preterm infants.
Time Frame
38 weeks gestation on average
Secondary Outcome Measure Information:
Title
Time to discharge
Description
Assess the relationship between feeding schedule and overall length of hospitalization.
Time Frame
40 weeks gestation on average
Title
Medical Complications
Description
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
Title
Growth
Description
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
Title
Feeding skills
Description
Assess feeding competence and sucking skills from initiation of feeds through discharge on full oral feeds.
Time Frame
40 weeks gestation on average
10. Eligibility
Sex
All
Maximum Age & Unit of Time
120 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age between 23 0/7-33 0/7 weeks
Eligible for oral (PO) feeding as determined by the attending Neonatologist
Exclusion Criteria:
Infants with major congenital malformations
Infants with chromosomal defects
Diagnosis of Neonatal Abstinence Syndrome or opiate withdrawal
Grade 3 or 4 Intraventricular Hemorrhage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara B DeMauro, MD, MSCE
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feeding Progression in Preterm Infants
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