Anemia of Prematurity and Hemodynamics

NCT05496400 | Completed

• 1 other identifier: 0106769
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Group I

(anemic group)

Radiation: Echocardiographic and Doppler studies

Group II

(non-anemic group)

Radiation: Echocardiographic and Doppler studies

Interventions

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: 1. Cardiac output: 2. Cerebral, intestinal and renal blood flow velocities:

Group I; Group II

Eligibility Criteria

• Age: 3 Weeks - 6 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Marwa Mohamed Farag: lead

Study Sites (1)

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

Alexandria, 21131, Egypt

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Ahmed Adel El Beheiry, PhD

  Faculty of medicine, Alexandria University, Egypt

  STUDY CHAIR

• Amany Tolba Elsebaee, MBBCh

  Faculty of medicine, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: July 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 12, 2022

Record last verified: 2022-08

Locations

EG (1)