Anemia of Prematurity and Hemodynamics

Sponsor
Marwa Mohamed Farag (Other)
Overall Status
Completed
CT.gov ID
NCT05496400
Collaborator
(none)
72
1
13
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
72 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Effect of Anemia of Prematurity and Its Treatment on Hemodynamics of Preterm Infants
Actual Study Start Date :
Jul 1, 2021
Actual Primary Completion Date :
Feb 1, 2022
Actual Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm 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:

Outcome Measures

Primary Outcome Measures

  1. 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. 2. Cerebral blood flow velocities [3-6 weeks postnatal age]

    in the anterior cerebral artery through the anterior fontanelle in the sagittal plane

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Weeks to 6 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Preterm infants ≤32 weeks gestational age, regardless their weight with postnatal age 3-6 weeks.
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital. Alexandria Egypt 21131

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marwa Mohamed Farag, Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine, Alexandria University
ClinicalTrials.gov Identifier:
NCT05496400
Other Study ID Numbers:
  • 0106769
First Posted:
Aug 11, 2022
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2022