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Completed

NCT Number: NCT05496400

Anemia of Prematurity and Hemodynamics

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.

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Key information

Conditions

Premature Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

3 week–6 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Alexandria, 21131, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Echocardiographic and Doppler studies

Radiation

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:

Primary outcomes

  1. 1. Cardiac output:

    Time frame: 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

    Time frame: 3-6 weeks postnatal age

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

  3. 3. Intestinal blood flow velocities

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Marwa Mohamed Farag

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 11, 2022
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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