- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01787019
Initiation of Oral Feeding at 30 Versus 33 Weeks Postmenstrual Age
May 12, 2016 updated by: Kathleen Kennedy, The University of Texas Health Science Center, Houston
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Children's Memorial Hermann Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 month (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 30 weeks
initiation of oral feedings at 30 weeks
|
|
Active Comparator: 33 weeks
initiation of oral feedings at 33 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postmenstrual age at full oral feeding
Time Frame: until hospital discharge (typically 36 weeks postmenstrual age)
|
defined as the infant orally consuming the volume of formula/breastmilk as prescribed by the attending physician without requiring gavage feedings for 2 days
|
until hospital discharge (typically 36 weeks postmenstrual age)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
postmenstrual age at discharge
Time Frame: until hospital discharge (typically 36 weeks postmenstrual age)
|
until hospital discharge (typically 36 weeks postmenstrual age)
|
growth between enrollment and 36 weeks postmenstrual age
Time Frame: until hospital discharge (typically 36 weeks postmenstrual age)
|
until hospital discharge (typically 36 weeks postmenstrual age)
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
average FiO2
Time Frame: at 33 weeks postmenstrual age
|
at 33 weeks postmenstrual age
|
use of positive pressure (yes/no)
Time Frame: 33 weeks postmenstrual age
|
33 weeks postmenstrual age
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
February 4, 2013
First Submitted That Met QC Criteria
February 7, 2013
First Posted (Estimate)
February 8, 2013
Study Record Updates
Last Update Posted (Estimate)
May 13, 2016
Last Update Submitted That Met QC Criteria
May 12, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Age of Oral Feeding
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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