NCT02733718

Brief Summary

This study aims to compare the differences between three different feeding regimens on intestinal oxygenation during packed red blood cell (PRBC) transfusion in premature babies.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

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

Study Start

First participant enrolled

November 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 11, 2016

Status Verified

April 1, 2016

Enrollment Period

1.6 years

First QC Date

February 28, 2016

Last Update Submit

April 8, 2016

Conditions

Necrotizing Enterocolitis

Keywords

Necrotizing enterocolitisTransfusionMesenteric Oxygenisation

Outcome Measures

Primary Outcomes (1)

  • mesenteric oxygenisation (number of participants that has low mesenteric oxygenisation after transfusion)

    number of participants that has low mesenteric oxygenisation after transfusion

    48 hours

Secondary Outcomes (2)

  • Feeding intolerance (number of participants that has feeding intolerance after transfusion)

    starting with transfusion until discharge, assessed up to 12 weeks

  • NEC (number of participants that has occurred transfusion related NEC)

    starting with transfusion until discharge, assessed up to 12 weeks

Study Arms (3)

Group 1: no enteral feeding

OTHER

intervention: NIRS (near-infrared spectroscopy)

Device: NIRS (near-infrared spectroscopy)

Group 2: Feeding is reduced by %50

OTHER

intervention: NIRS (near-infrared spectroscopy)

Device: NIRS (near-infrared spectroscopy)

Group 3: Feeding will be continued

OTHER

intervention: NIRS (near-infrared spectroscopy)

Device: NIRS (near-infrared spectroscopy)

Interventions

NIRS (near-infrared spectroscopy)DEVICE

mesenteric oxygenisation measurement

Group 1: no enteral feedingGroup 2: Feeding is reduced by %50Group 3: Feeding will be continued

Eligibility Criteria

AgeUp to 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Prematurity (\<32 completed weeks of gestation at birth)
  • Need for PRBC transfusion
  • Feeding at least 30ml/kg/day at the time of transfusion

You may not qualify if:

  • Neonates previously diagnosed with gastrointestinal problems such as NEC, intestinal perforation or atresia.
  • Infants receiving continuous feeds or less than 30ml/kg/day
  • Major congenital or chromosomal abnormalities or infants unlikely to survive
  • Intraventricular hemorrhage \>Grade 3
  • Hemodynamically significant patent ductus arteriosus
  • Infants requiring vasopressor support
  • Skin disruption precluding application of sensors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • Marin T. Mesenteric perfusion pattern changes as the result of packed red blood cell transfusions in preterm infants. (Doctoral Dissertation). 2012. Retrieved from Emory Electronic Theses and Dissertations Repository. UMI number 3522333. [cited 2013 Feb 20]

    RESULT

  • Marin T, Moore J, Kosmetatos N, Roback JD, Weiss P, Higgins M, McCauley L, Strickland OL, Josephson CD. Red blood cell transfusion-related necrotizing enterocolitis in very-low-birthweight infants: a near-infrared spectroscopy investigation. Transfusion. 2013 Nov;53(11):2650-8. doi: 10.1111/trf.12158. Epub 2013 Mar 11.

    PMID: 23480548RESULT

  • Bailey SM, Hendricks-Munoz KD, Mally P. Splanchnic-cerebral oxygenation ratio as a marker of preterm infant blood transfusion needs. Transfusion. 2012 Feb;52(2):252-60. doi: 10.1111/j.1537-2995.2011.03263.x. Epub 2011 Jul 25.

    PMID: 21790634RESULT

  • Stritzke AI, Smyth J, Synnes A, Lee SK, Shah PS. Transfusion-associated necrotising enterocolitis in neonates. Arch Dis Child Fetal Neonatal Ed. 2013 Jan;98(1):F10-4. doi: 10.1136/fetalneonatal-2011-301282. Epub 2012 Mar 23.

    PMID: 22447991RESULT

  • Christensen RD, Lambert DK, Henry E, Wiedmeier SE, Snow GL, Baer VL, Gerday E, Ilstrup S, Pysher TJ. Is "transfusion-associated necrotizing enterocolitis" an authentic pathogenic entity? Transfusion. 2010 May;50(5):1106-12. doi: 10.1111/j.1537-2995.2009.02542.x. Epub 2009 Dec 29.

    PMID: 20051059RESULT

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Hülya Selva Bilgen, MD

    professor

    STUDY DIRECTOR

Central Study Contacts

Hülya Selva Bilgen, MD

CONTACT

0905332612124hülya.bilgen@gmail.com

Sevgi Aslan, MD

CONTACT

0905545497372sevgi.asln@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2016

First Posted

April 11, 2016

Study Start

November 1, 2015

Primary Completion

June 1, 2017

Study Completion

September 1, 2017

Last Updated

April 11, 2016

Record last verified: 2016-04

Locations

TU(1)