CClinicalTrials.gg
Status unknownNCT04083638Updated Sep 10, 2019

The Relationship Between Erythrocyte Transfusion and Nutrition and Necrotizing Enterocolitis in Preterm Infants

An observational study in Necrotizing Enterocolitis of Newborn, sponsored by Dr. Behcet Uz Children's Hospital. Status unknown at 1 site in Turkey. Open to participants aged Up to 1 Month. Per ClinicalTrials.gov, last updated 2019-09-10.

Sponsored by Dr. Behcet Uz Children's Hospital · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
81
Ages
Up to 1 Month
Sex
All
01

Study summary

In this study; The aim of this study was to investigate the changes in fasting and dietary and mesenteric blood flow in the acute period during and after transfusion and to evaluate the necrotizing enterocolitis.

02

Conditions studied

  • Necrotizing Enterocolitis of Newborn
03

In context

Enterocolitis

216 studies on the registry are indexed under Enterocolitis; 26 are open to participants now.

This study's planned enrollment of 81 is close to the median of 78 across 86 observational studies indexed under Enterocolitis.

Browse Enterocolitis studies →

Lead sponsor

Dr. Behcet Uz Children's Hospital is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

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

04

Who can participate

Ages eligible
Up to 1 Month
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Preterm infants

Inclusion criteria

  • \<32 gestational week and/or \<1500 g birth weight

Exclusion criteria

Exclusion Criteria:

  • Major congenital anomalies, hemodynamic instability
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
81 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group 1

    Control group

    Diagnostic Test: IFAB

  • Group 2

    Feeding will not stop during the transfusion

    Diagnostic Test: IFAB

Interventions

  • Diagnostic testIFAB

    Intestinal Fatty Acid Binding Protein will be taken from all participants before the tx and after the tx

06

What researchers measure

Primary outcomes

  1. necrotizing enterocolitis

    Time frame: 0-48 hours after tx

  2. Mortality

    If all babies die after tx study will be finished

    Time frame: 0-24 hour after tx

07

Study locations

1 of 1 sites recruiting
  • Behçet Uz Children's Hospital
    İzmirli, Izmir 35210, Turkey
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04083638
Lead sponsor
Dr. Behcet Uz Children's Hospital
Responsible party
Senem Alkan Özdemir (MD, Associate Professor of Neonatology, Dr. Behcet Uz Children's Hospital) — Principal investigator
First posted
Sep 10, 2019
Start date
Jan 1, 2020 (estimated)
Primary completion
Jun 30, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Sep 10, 2019

Study contacts

Senem A Özdemir, MD
Contact
drsenemalkan@yahoo.com
05327614670
Şebnem A Çalkavur, MD
Contact
sebnemcalkavur@yahoo.com
05327614670
Rüya Çolak, MD
study chair · Behcet Uz Children's Hospital

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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