Anemia of Prematurity and Hemodynamics

Completed

• Conditions: Premature
• Interventions: Radiation: Echocardiographic and Doppler studies

• Registration Number: NCT05496400
• Lead Sponsor: Marwa Mohamed Farag

Brief 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.

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 Timeline

• Study Start: 2021-07-01
• Primary Completion: 2022-02-01
• Status Verified: 2022-08
• Study Completion: 2022-08-01
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Last Update Submitted: 2022-08-10
• Study First Posted: 2022-08-11
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group I	Echocardiographic and Doppler studies	(anemic group)
Group II	Echocardiographic and Doppler studies	(non-anemic group)

Primary Outcome Measures

Name	Time	Method
1. Cardiac output:	3-6 weeks postnatal age	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.(
2. Cerebral blood flow velocities	3-6 weeks postnatal age	in the anterior cerebral artery through the anterior fontanelle in the sagittal plane
4.Renal blood flow velocities	3-6 weeks postnatal age	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. Intestinal blood flow velocities	3-6 weeks postnatal age	in the celiac artery from a longitudinal abdominal section, determined close to the origin of the artery from the abdominal aorta.

Trial Locations

Locations (1)

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.; 🇪🇬 Alexandria, Egypt