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

Anemia of Prematurity Clinical Trial

Official title:

The Effect of Packed Red Blood Cell Transfusion on Superior Mesenteric Artery Blood Flow Velocity in Premature Infants After Feeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00167388
• Other study ID #: 0404184
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: March 25, 2008
• Start date: September 2005
• Est. completion date: November 2006

Study information

• Verified date: March 2008
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Currently a disparity exists among the NICU staff at Magee-Womens Hospital regarding whether premature infants should be fed during a blood transfusion. The effects of a blood transfusion on superior mesenteric artery blood flow velocity and the post-prandial hyperemia are not known.

We hypothesize that the post-prandial change in mesenteric blood flow velocity (BFV) will be the same before as after a packed red blood cell (PRBC) transfusion among anemic premature infants.

Sixty anemic infants (25-32 weeks GA, feeding >= 60 cc/kg/day) will undergo pre- and post-feed superior mesenteric artery Doppler studies both before and after a blood transfusion. Infants will be stratified by current weight into two groups (< 1250 grams and > 1250 grams). In each weight stratum the infants will be randomized to feeding or NPO during the PRBC transfusion. Randomization will be by block design, with block sizes ranging from two to six infants. The investigator performing the Doppler studies will remain masked to the feeding assignment of the infant.

The primary outcome for the study is the superior mesenteric artery blood flow velocity response to feeding between anemic and non-anemic states among premature infants. Our secondary outcome is the effect of feeding on BFV between anemic and non-anemic states in these infants. Statistical analysis will include paired and unpaired Student t-tests and regression analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Weeks to 38 Weeks

Eligibility

Inclusion Criteria:

1. Singleton infants born at 25-32 weeks gestation who are < 38 weeks post-conceptual age at enrollment

2. 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.

3. Receiving bolus enteral feeds [PO (bottle) and/or PE (feeding tube)] of at least 60 cc/kg/day

4. A planned packed red blood cell transfusion, as per the clinical team, for anemia

5. Infant is very likely to require a blood transfusion according to the attending neonatologist.

Exclusion Criteria:

1. Known congenital anomalies of the heart, brain, kidneys or intestine

2. Chromosomal abnormality

3. Intrauterine growth restriction at < 3% for weight at birth since this has been shown to alter mesenteric BFV and the post-prandial hyperemia

4. Twin to twin transfusion sequence

5. Higher order multiples

6. Patent ductus arteriosus known to be present or currently being treated

7. History of definite necrotizing enterocolitis Bell Stage 2 or greater

8. Concurrent treatments with antibiotics or steroids

9. Feeding intolerance, defined as gastric aspirate > 30% of feed volume on 3 sequential feeds

10. Concurrent enrollment in another randomized trial

11. Infants discharged or transferred to another facility without having received a PRBC transfusion will be excluded post-hoc.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia of Prematurity
• Anemia, Neonatal
• Infant, Premature, Diseases
• Premature Birth

Intervention

Procedure:
• feed during blood transfusion

• nothing by mouth (NPO) during blood transfusion

Locations

Country	Name	City	State
United States	Magee-Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Irene McLeneham Young Investigator Award through Magee Womens Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in superior mesenteric artery blood flow velocity from pre-to-post feed in the anemic versus transfused state
Secondary	Effect of feeding versus NPO during transfusion on the change in superior mesenteric artery blood flow velocity from pre-to-post feed in the anemic versus transfused state