The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants

NCT00167388 | Completed Phase 1 Results DMC

• 1 other identifier: 0404184
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to see if a blood transfusion changes how fast blood flows to the intestines of a premature baby. Blood flow is measured by an ultrasound test. The investigators also look to see if the blood flow to the intestines depends on whether the baby feeds or doesn't feed during the blood transfusion.

Conditions

Anemia of Prematurity

Keywords

anemia; prematurity; blood flow velocity; superior mesenteric artery; intestinal blood flow in premature infants

Outcome Measures

Primary Outcomes (1)

• Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States

  Time-averaged mean and Peak systolic Doppler blood flow velocity in the mesenteric artery was measured before and after a feed when the baby was anemic (pre-PRBC transfusion) and then again when the baby was immediately post-transfusion

  1 hour

Study Arms (4)

group 1

NO INTERVENTION

All babies \<1250 gm at the time of the study are enrolled into this arm, and randomized to be NPO during the PRBC transfusion

group 2

ACTIVE COMPARATOR

Babies \<1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion

Other: feed during blood transfusion

group 3

NO INTERVENTION

All babies \>1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion

group 4

EXPERIMENTAL

All babies \<1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion

Other: feed during blood transfusion

Interventions

feed during blood transfusion OTHER

babies receiving the intervention are fed during the PRBC transfusion

group 2; group 4

Eligibility Criteria

• Age: 25 Weeks - 38 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Singleton infants born at 25-32 weeks gestation who are \< 38 weeks post-conceptual age at enrollment
• First infant of twin gestation born at 25-32 weeks gestation who requires a blood transfusion; if both infants require transfusion on the same day the larger infant will be enrolled.
• Receiving bolus enteral feeds \[PO (bottle) and/or PE (feeding tube)\] of at least 60 cc/kg/day
• A planned packed red blood cell transfusion, as per the clinical team, for anemia
• Infant is very likely to require a blood transfusion according to the attending neonatologist.

You may not qualify if:

• Known congenital anomalies of the heart, brain, kidneys or intestine
• Chromosomal abnormality
• Intrauterine growth restriction at \< 3% for weight at birth since this has been shown to alter mesenteric BFV and the post-prandial hyperemia
• Twin to twin transfusion sequence
• Higher order multiples
• Patent ductus arteriosus known to be present or currently being treated
• History of definite necrotizing enterocolitis Bell Stage 2 or greater
• Concurrent treatments with antibiotics or steroids
• Feeding intolerance, defined as gastric aspirate \> 30% of feed volume on 3 sequential feeds
• Concurrent enrollment in another randomized trial
• Infants discharged or transferred to another facility without having received a PRBC transfusion will be excluded post-hoc.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Irene McLeneham Young Investigator Award through Magee Womens Research Institute: collaborator

Study Sites (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Anemia; Premature Birth

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Dr. Toby Yanowitz
• Organization: University of Pittsburgh

yanotd@mail.magee.edu

412-641-4111

Study Officials

• Gretchen Krimmel, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: September 1, 2005
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: July 21, 2017
• Results First Posted: July 21, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)