Anemia of Prematurity and Hemodynamics

Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05496400
• Other study ID #: 0106769
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: August 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Weeks to 6 Weeks

Eligibility

Inclusion Criteria:

• Preterm infants =32 weeks gestational age, regardless their weight with postnatal age 3-6 weeks. Exclusion Criteria: -

Related Conditions & MeSH terms

• Premature
• Premature Birth

Intervention

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:

Locations

Country	Name	City	State
Egypt	Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Marwa Mohamed Farag

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	2. Cerebral blood flow velocities	in the anterior cerebral artery through the anterior fontanelle in the sagittal plane	3-6 weeks postnatal age
Primary	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
Primary	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