Enteral Feeding IntoleranceNCT05265143
Comparision of Two Different Feeding Method in Preterms
A study testing bolus/intermittant feeding in people with Enteral Feeding Intolerance, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Enteral Feeding Intolerance
- What is being tested?
- bolus/intermittant feeding
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2015to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- <1750 gr preterm infants
- <33 gw
- admitted to our nicu in first day of life
Who cannot join
- major congenital anomalies gis anomalies septic shock exitus in 3 days of life
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparision of Two Different Feeding Method in Preterm Infants
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.
Read the 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.
- Conditions
- Enteral Feeding Intolerance
- Being tested
- bolus/intermittant feeding
- Keywords
- preterm, feeding intolerence
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bolus/intermittant feedingOther
sequential randomization
| Study group | Role | What they receive |
|---|---|---|
| bolus feeding group | Other | In bolus feednig group preterm fed by via gravity drip over a short period, usually 15-20 min. it administrated 8-12 times daily Receives: Other: bolus/intermittant feeding |
| intermittant feeding group | Other | Intermittant feeding is delivered over a 30-60 min by infusion pump. it administrated 8-12 times daily Receives: Other: bolus/intermittant feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of feeding intolerence
The effect of two different gavage tube feeding methods on feeding intolerance
Measured: 1 month
Secondary outcomes (1)
time to reach full enteral feeding
The effect of two different gavage tube feeding methods on time to reach full enteral feeding
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start1 Jan 2015
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enteral Feeding IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Yavanoglu Atay, Zekai Tahir Burak Women's Health Research and Education Hospital
- Investigators
- Funda Yavanoğlu Atay, md, Principal investigator, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265143
- Sponsor's protocol ID
- 2579
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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(8):CD009719. doi: 10.1002/14651858.CD009719.pub3.
PubMed 34355390
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparision of Two Different Feeding Method in Preterm Infants
- ClinicalTrials.gov ID
- NCT05265143
- Acronym / sponsor ID
- 2579
- Conditions
- Enteral Feeding Intolerance
- Keywords
- preterm, feeding intolerence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bolus feeding group | Other | Other: bolus/intermittant feedingIn 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 group | Other | Other: bolus/intermittant feedingIntermittant feeding is delivered over a 30-60 min by infusion pump. it administrated 8-12 times daily |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- <1750 gr preterm infants
- <33 gw
- admitted to our nicu in first day of life
Key exclusion criteria (2 listed)
- major congenital anomalies gis anomalies septic shock exitus in 3 days of life
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bolus/intermittant feedingsequential randomization | Other | bolus feeding group, intermittant feeding group |
Primary outcome
rate of feeding intolerence
Time frame: 1 month
The effect of two different gavage tube feeding methods on feeding intolerance
1 secondary outcome
time to reach full enteral feeding
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 34355390Richards 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Funda Yavanoğlu Atay, md principal investigator
Zekai Tahir Burak Women's Health Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bolus/intermittant feeding in people with Enteral Feeding Intolerance, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of feeding intolerence (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05265143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.