Back to resultsInitiation of Oral Feeding at 30 Versus 33 Weeks Postmenstrual Age
Primary Purpose
Prematurity
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oral feeding
Sponsored by
About this trial
This is an interventional treatment trial for Prematurity
Eligibility Criteria
Inclusion Criteria:
- Gestational age <= 29 weeks at birth
- Tolerating enteral feedings for at least 3 days before 30 weeks postmenstrual age
Exclusion Criteria:
- Neurologic, cardiac, respiratory, or gastrointestinal disorders that interfere with oral feeding
Sites / Locations
- Children's Memorial Hermann Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
30 weeks
33 weeks
Arm Description
initiation of oral feedings at 30 weeks
initiation of oral feedings at 33 weeks
Outcomes
Primary Outcome Measures
Postmenstrual age at full oral feeding
defined as the infant orally consuming the volume of formula/breastmilk as prescribed by the attending physician without requiring gavage feedings for 2 days
Secondary Outcome Measures
postmenstrual age at discharge
growth between enrollment and 36 weeks postmenstrual age
Full Information
NCT ID
NCT01787019
First Posted
February 4, 2013
Last Updated
May 12, 2016
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT01787019
Brief Title
Initiation of Oral Feeding at 30 Versus 33 Weeks Postmenstrual Age
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to determine if earlier initiation of oral (by mouth as opposed to tube) feedings in premature infants results in earlier attainment of full oral feedings and/or discharge.
Detailed Description
Infants will be enrolled and randomized at 30 0/7 weeks postmenstrual age. The Earlier Oral Feeding group will initiate oral feedings at 30 0/7 weeks postmenstrual age. The Later Oral Feeding group will initiate oral feedings at 33 0/7 weeks postmenstrual age. The number of oral feeding attempts will be advanced according to a feeding progression protocol for both groups. Successful completion of a feeding is defined as oral completion of the full volume of a feeding within 30 minutes, without a bradycardic episode (heart rate <100 beats per minute) or desaturation (oxygen saturation decrease >5% from baseline values). If infant does not successfully complete >95% of the total prescribed volume of a feeding, the remainder of the volume will be supplied via gastric tube. All oral feedings will be performed by bedside nurses, or by a parent with observation by the nursing staff, with continuous cardiorespiratory and pulse oximetry monitoring. Individual oral feeding attempts for both groups will continue until one of the following occurs despite appropriate pacing of the feeding: 1) the feeding is completed 2) feeding duration of 30 minutes 3) adverse event during a feeding [multiple bradycardic episodes (3 episodes of heart rate <100 beats per minute), bradycardia with choking episode, single severe bradycardia (heart rate <60)]. If the infant experiences an adverse event during an oral feeding attempt, oral feeding attempts will be held for 2 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
30 weeks
Arm Type
Experimental
Arm Description
initiation of oral feedings at 30 weeks
Arm Title
33 weeks
Arm Type
Active Comparator
Arm Description
initiation of oral feedings at 33 weeks
Intervention Type
Other
Intervention Name(s)
Oral feeding
Primary Outcome Measure Information:
Title
Postmenstrual age at full oral feeding
Description
defined as the infant orally consuming the volume of formula/breastmilk as prescribed by the attending physician without requiring gavage feedings for 2 days
Time Frame
until hospital discharge (typically 36 weeks postmenstrual age)
Secondary Outcome Measure Information:
Title
postmenstrual age at discharge
Time Frame
until hospital discharge (typically 36 weeks postmenstrual age)
Title
growth between enrollment and 36 weeks postmenstrual age
Time Frame
until hospital discharge (typically 36 weeks postmenstrual age)
Other Pre-specified Outcome Measures:
Title
average FiO2
Time Frame
at 33 weeks postmenstrual age
Title
use of positive pressure (yes/no)
Time Frame
33 weeks postmenstrual age
10. Eligibility
Sex
All
Maximum Age & Unit of Time
7 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age <= 29 weeks at birth
Tolerating enteral feedings for at least 3 days before 30 weeks postmenstrual age
Exclusion Criteria:
Neurologic, cardiac, respiratory, or gastrointestinal disorders that interfere with oral feeding
Facility Information:
Facility Name
Children's Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Initiation of Oral Feeding at 30 Versus 33 Weeks Postmenstrual Age
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