NCT05265143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

March 19, 2026

Status Verified

February 1, 2022

Enrollment Period

7.4 years

First QC Date

February 9, 2022

Last Update Submit

March 18, 2026

Conditions

Keywords

pretermfeeding intolerence

Outcome Measures

Primary Outcomes (1)

  • rate of feeding intolerence

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

    1 month

Secondary Outcomes (1)

  • time to reach full enteral feeding

    1 month

Study Arms (2)

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

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

Other: bolus/intermittant feeding

Interventions

sequential randomization

bolus feeding groupintermittant feeding group

Eligibility Criteria

Age1 Day - 3 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ümraniye Teaching Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Funda Yavanoğlu Atay, md

    Zekai Tahir Burak Women's Health Research and Education Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 9, 2022

First Posted

March 3, 2022

Study Start

January 1, 2015

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

March 19, 2026

Record last verified: 2022-02

Locations