Anemia of Prematurity and Hemodynamics

Effect of Anemia of Prematurity and Its Treatment on Hemodynamics of Preterm Infants

The aim of this work to study the hemodynamic changes accompanying anemia of prematurity in neonates with gestational age ≤32 weeks and the effect of its treatment on hemodynamics.

Study Overview

• Status: Completed
• Conditions: Premature
• Intervention / Treatment: Radiation: Echocardiographic and Doppler studies

Detailed Description

This prospective observational study aims to evaluate the hemodynamic changes provoked by anemia of prematurity and transfusion of packed red blood cells (RBCs). Nonanemic inpatient premature infants (Hematocrit>30%) will be compared with pretransfusional anemic inpatient premature infants. Anemic premature infants will be assessed before and 24 hours after the transfusion of pRBCs. Cerebral, intestinal and renal blood flow velocities, cardiac output parameters will be measured in premature neonates who will fulfill the eligibility criteria of the study.This study will be conducted at the neonatal intensive care units in Alexandria University Hospitals.

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21131
    • Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 weeks to 1 month (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with any of the following will be excluded at the time of assessment:

• Hemolytic disease of the newborn.
• Shock.
• Sepsis.
• Ultrasonographic abnormalities of kidney, heart and cerebral structures.

Description

Inclusion Criteria:

• Preterm infants ≤32 weeks gestational age, regardless their weight with postnatal age 3-6 weeks.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I; (anemic group)	Radiation: Echocardiographic and Doppler studies; Echographic and Doppler studies will be performed using machine: model GE Vivid iq premium,WUXI,China and we will measure: Cardiac output:; Cerebral, intestinal and renal blood flow velocities:
Group II; (non-anemic group)	Radiation: Echocardiographic and Doppler studies; Echographic and Doppler studies will be performed using machine: model GE Vivid iq premium,WUXI,China and we will measure: Cardiac output:; Cerebral, intestinal and renal blood flow velocities:

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Cardiac output:	Probe: GE 12S-RS probe with a frequency range of 5 - 11 MHz. Cardiac output as the product of stroke volume and heart rate: actual body weight in mL/kg/min; Stroke volume (the product of velocity time integral at the level of aortic valve pulsed wave (PW) and cross-sectional area of the left ventricular outflow tract at the level of aortic valve using 2D.(	3-6 weeks postnatal age
2. Cerebral blood flow velocities	in the anterior cerebral artery through the anterior fontanelle in the sagittal plane	3-6 weeks postnatal age
3. Intestinal blood flow velocities	in the celiac artery from a longitudinal abdominal section, determined close to the origin of the artery from the abdominal aorta.	3-6 weeks postnatal age
4.Renal blood flow velocities	Renal blood flow velocities in the right renal artery by placing the transducer below the right costal arch in the dorsolateral area of the flank in longitudinal axis.	3-6 weeks postnatal age

Collaborators and Investigators

• Sponsor: Marwa Mohamed Farag
• Investigators: Study Chair: Ahmed Adel El Beheiry, PhD, Faculty of Medicine, Alexandria University, Egypt; Principal Investigator: Amany Tolba Elsebaee, MBBCh, Faculty of Medicine, Alexandria University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 0106769

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No