NCT04083638

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

September 6, 2019

Last Update Submit

September 6, 2019

Conditions

Necrotizing Enterocolitis of Newborn

Outcome Measures

Primary Outcomes (2)

  • necrotizing enterocolitis

    0-48 hours after tx

  • Mortality

    If all babies die after tx study will be finished

    0-24 hour after tx

Study Arms (2)

Group 1

Control group

Diagnostic Test: IFAB

Group 2

Feeding will not stop during the transfusion

Diagnostic Test: IFAB

Interventions

IFABDIAGNOSTIC_TEST

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

Group 1Group 2

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Preterm infants

You may qualify if:

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

You may not qualify if:

  • Major congenital anomalies, hemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behçet Uz Children's Hospital

İzmirli, İzmir, 35210, Turkey (Türkiye)

RECRUITING

Study Officials

  • Rüya Çolak, MD

    Behcet Uz Children's Hospital

    STUDY CHAIR

Central Study Contacts

Senem A Özdemir, MD

CONTACT

05327614670drsenemalkan@yahoo.com

Şebnem A Çalkavur, MD

CONTACT

05327614670sebnemcalkavur@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Associate Professor of Neonatology

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 10, 2019

Study Start

January 1, 2020

Primary Completion

June 30, 2020

Study Completion

December 31, 2020

Last Updated

September 10, 2019

Record last verified: 2019-09

Locations

TU(1)