Comparision of Two Different Feeding Method in Preterms
Primary Purpose
Enteral Feeding Intolerance
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
bolus/intermittant feeding
Sponsored by
About this trial
This is an interventional other trial for Enteral Feeding Intolerance focused on measuring preterm, feeding intolerence
Eligibility Criteria
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
-
Sites / Locations
- Ümraniye Teaching HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
bolus feeding group
intermittant feeding group
Arm Description
In bolus feednig group preterm fed by via gravity drip over a short period, usually 15-20 min. it administrated 8-12 times daily
Intermittant feeding is delivered over a 30-60 min by infusion pump. it administrated 8-12 times daily
Outcomes
Primary Outcome Measures
rate of feeding intolerence
The effect of two different gavage tube feeding methods on feeding intolerance
Secondary Outcome Measures
time to reach full enteral feeding
The effect of two different gavage tube feeding methods on time to reach full enteral feeding
Full Information
NCT ID
NCT05265143
First Posted
February 9, 2022
Last Updated
March 2, 2022
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05265143
Brief Title
Comparision of Two Different Feeding Method in Preterms
Official Title
Comparision of Two Different Feeding Method in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
achievement of optimal postnatal growth by adequate enteral nutrition in critically ill preterm infants is a challenge of NICU. signs like abdominal distension, reflux, vomiting, nec is a factors of discontinuing fedding in preterm. this factors plays a role in decisions about which method of gavage feeding is adopted. we compare two different feeding method to achive less fedding tolerence.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enteral Feeding Intolerance
Keywords
preterm, feeding intolerence
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bolus feeding group
Arm Type
Other
Arm Description
In bolus feednig group preterm fed by via gravity drip over a short period, usually 15-20 min. it administrated 8-12 times daily
Arm Title
intermittant feeding group
Arm Type
Other
Arm Description
Intermittant feeding is delivered over a 30-60 min by infusion pump. it administrated 8-12 times daily
Intervention Type
Other
Intervention Name(s)
bolus/intermittant feeding
Intervention Description
sequential randomization
Primary Outcome Measure Information:
Title
rate of feeding intolerence
Description
The effect of two different gavage tube feeding methods on feeding intolerance
Time Frame
1 month
Secondary Outcome Measure Information:
Title
time to reach full enteral feeding
Description
The effect of two different gavage tube feeding methods on time to reach full enteral feeding
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
funda atay
Phone
+905054409167
Email
funday.atay@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Funda Yavanoğlu Atay, md
Organizational Affiliation
Zekai Tahir Burak Women's Health Research and Education Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ümraniye Teaching Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ilke mungan akın
12. IPD Sharing Statement
Citations:
PubMed Identifier
34355390
Citation
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(8):CD009719. doi: 10.1002/14651858.CD009719.pub3.
Results Reference
background
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Comparision of Two Different Feeding Method in Preterms
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