Clinical trial NCT02027688: Feeding Progression in Preterm Infants
Official title: Feeding Progression in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature, Diseases
Feeding Behavior
Feeding Patterns
Keywords: Oral feeding
Premature
Infants
Neonatal Intensive Care Unit
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2014-01-06
Enrollment: 55
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to full oral feeds
timeFrame: 38 weeks gestation on average
Secondary outcomes:
measure: Time to discharge
timeFrame: 40 weeks gestation on average
measure: Medical Complications
timeFrame: 38 weeks gestation on average
measure: Growth
timeFrame: 40 weeks gestation on average
measure: Feeding skills
timeFrame: 40 weeks gestation on average
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Sara B DeMauro, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: