- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05265143
Comparision of Two Different Feeding Method in Preterms
Comparision of Two Different Feeding Method in Preterm Infants
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
<1750 gr, <33 gw infants will enroll study. exckusion criteria: major congenital anomalies major gis anomalies
The study infants are enrolled within 24 hours of birth and sequently randomized to either intermitten feeding (IF) and bolus feeding (BF). Intermittent feeding is defined as delivering enteral nutrition and generally giving 60 min and 2 hours no feeding. this circle repeats 8 times in 24 hours. Bolus feeding is the amount of nutrition put into the syringe was kept 10 cm above the baby and the fluidity was obtained by gravity through the orogastric tube. The data of the patients such as feeding intolerance (gastric residual volume more than %50 of the previous feeding volume, gastric regurgitation, abdominal distension and/or emesis ), whether there is a week-by-week feeding intolerance were noted, NEC, time to reached birth weight, time to achieved full enteral feeding, every 5 minutes during feeding, saturation, respiratory rate and heart rates will record.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Ümraniye Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- <1750 gr preterm infants
- <33 gw
- admitted to our nicu in first day of life
Exclusion Criteria:
major congenital anomalies gis anomalies septic shock exitus in 3 days of life
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: bolus feeding group
In bolus feednig group preterm fed by via gravity drip over a short period, usually 15-20 min.
it administrated 8-12 times daily
|
sequential randomization
|
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Other: intermittant feeding group
Intermittant feeding is delivered over a 30-60 min by infusion pump. it administrated 8-12 times daily
|
sequential randomization
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
rate of feeding intolerence
Time Frame: 1 month
|
The effect of two different gavage tube feeding methods on feeding intolerance
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
time to reach full enteral feeding
Time Frame: 1 month
|
The effect of two different gavage tube feeding methods on time to reach full enteral feeding
|
1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Funda Yavanoğlu Atay, md, Zekai Tahir Burak Women's Health Research and Education Hospital
Publications and helpful links
General Publications
- Richards R, Foster JP, Psaila K. Continuous versus bolus intermittent intragastric tube feeding for preterm and low birth weight infants with gastro-oesophageal reflux disease. Cochrane Database Syst Rev. 2021 Aug 6;8:CD009719. doi: 10.1002/14651858.CD009719.pub3. Review.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2579
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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