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CompletedNCT05265143Updated Mar 19, 2026

Comparision of Two Different Feeding Method in Preterms

An interventional study of bolus/intermittant feeding in Enteral Feeding Intolerance, sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 1 Day to 3 Days. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 7 years 1 month after the study started (first participant enrolled Jan 2015, registered Feb 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
1 Day to 3 Days
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Enteral Feeding Intolerance

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Keywords

  • preterm
  • feeding intolerence
03

In context

Premature Birth

2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.

This study's enrollment of 100 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital is the lead sponsor of 62 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 3 Days
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • \<1750 gr preterm infants
  • \<33 gw
  • admitted to our nicu in first day of life

Exclusion criteria

Exclusion Criteria:

major congenital anomalies gis anomalies septic shock exitus in 3 days of life

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05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Investigator)
Enrollment
100 participants (actual)

Study arms

  • 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

    Other: bolus/intermittant feeding

  • Other
    intermittant feeding group

    Intermittant feeding is delivered over a 30-60 min by infusion pump. it administrated 8-12 times daily

    Other: bolus/intermittant feeding

Interventions

  • Otherbolus/intermittant feeding

    sequential randomization

06

What researchers measure

Primary outcomes

  1. rate of feeding intolerence

    The effect of two different gavage tube feeding methods on feeding intolerance

    Time frame: 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

    Time frame: 1 month

07

Study locations

1 site
  • Ümraniye Teaching Hospital
    Istanbul, Turkey (Türkiye)
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2015 to primary completion in Jun 2022, 89 months.

Of 741 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 89 months is above that.

Counting every sponsor, half of 759 studies reached it within 24 months; a quarter within 12 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2022
First posted
Mar 3, 2022
StartActual
Jan 1, 2015
Primary completionActual
Jun 1, 2022
CompletionActual
Jun 1, 2022
Last update
Mar 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05265143
Lead sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
Responsible party
Funda Yavanoglu Atay (principal investigator, Zekai Tahir Burak Women's Health Research and Education Hospital) — Principal investigator
First posted
Mar 3, 2022
Start date
Jan 1, 2015
Primary completion
Jun 1, 2022
Completion
Jun 1, 2022
Last update
Mar 19, 2026

Study contacts

Funda Yavanoğlu Atay, md
principal investigator · Zekai Tahir Burak Women's Health Research and Education Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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