Withholding Feeds During Red Blood Cell Transfusion and TRAGI

NCT ID: NCT02132819

Last Updated: 2014-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-04-30

Brief Summary

Necrotising enterocolitis (NEC) is a devastating picture that all the neonatologists are afraid of facing during the follow up of newborns. During the last years, investigators ran retrospective observational studies abut NEC developing within the 48 hours after red blood cell transfusion. In the previous studies, the incidence of transfusion associated NEC (TANEC) was found to be 20-35%.Multiple transfusions potentially cause an increased risk for retinopathy of prematurity (ROP) and NEC. Investigators have also proposed a hypothesis about transfusion related acute gut injury (TRAGI), an adverse reaction of transfusion, similar to transfusion related acute lung injury (TRALI) seen in adults.In most of the neonatology clinics, withholding feeds during transfusion is not preferred. But several recent studies show an increase in the incidence of TANEC if the newborn goes on feeding before, during and after the transfusion process, especially if it is fed with a formula. The main aim of this study is to investigate the effect of withholding feeds during transfusion, on the development of TRAGI.

Conditions

Transfusion; Feeding During Transfusion; Transfusion Related Acute Gut Injury; Necrotising Enterocolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Feeding During Transfusion

The feeding process will be continued during the transfusion

Group Type: PLACEBO_COMPARATOR

feeding during transfusion

Intervention Type: OTHER

The feeding process will be continued during the transfusion

witholding feeds

At least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded

Group Type: ACTIVE_COMPARATOR

Withholding feeds

Intervention Type: OTHER

At least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded

Interventions

Withholding feeds

At least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded

Intervention Type: OTHER

feeding during transfusion

The feeding process will be continued during the transfusion

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• <32 weeks of gestational age or <1500 gr, >7 days old premature babies.
• Babies which are fed enterally well at the time of tha planning of transfusion.

Exclusion Criteria

• Babies with severe sepsis signs.
• Babies with severe hypoxia and asphyxia.
• Babies with congenital anomaly or complex cardiac anomaly.

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role: lead

Responsible Party

Suzan Sahin

Fellow in Neonatology, Pediatrician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzan Sahin, MD

Role: PRINCIPAL_INVESTIGATOR

Zekai Tahir Burak Women's Health Research and Education Hospital

Locations

Suzan Sahin

Ankara, Altındag, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Suzan Sahin, MD

Role: CONTACT

suzan_balkan@yahoo.com

Facility Contacts

Suzan Sahin, MD

Role: primary

suzan_balkan@yahoo.com

Other Identifiers

Sahin1

Identifier Type: -

Identifier Source: org_study_id