Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Feeding Progression in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02027688
Recruitment Status : Completed
First Posted : January 6, 2014
Last Update Posted : December 2, 2015
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Sara DeMauro, University of Pennsylvania

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.

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feeding Progression in Preterm Infants
Study Start Date : July 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time to discharge [ Time Frame: 40 weeks gestation on average ]
    Assess the relationship between feeding schedule and overall length of hospitalization.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 120 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
University of Pennsylvania
Children's Hospital of Philadelphia
Investigators
Layout table for investigator information
Principal Investigator: Sara B DeMauro, MD, MSCE Children's Hospital of Philadelphia
Layout table for additonal information
Responsible Party: Sara DeMauro, MD, MSCE, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02027688    
Other Study ID Numbers: 819247
First Posted: January 6, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015
Keywords provided by Sara DeMauro, University of Pennsylvania:
Oral feeding
Premature
Infants
Neonatal Intensive Care Unit
Additional relevant MeSH terms:
Layout table for MeSH terms
Infant, Premature, Diseases
Infant, Newborn, Diseases