PrematureNCT05496400
Anemia of Prematurity and Hemodynamics
An observational study of Premature, run by Marwa Mohamed Farag at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 3 to 6 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature
- What is being tested?
- Echocardiographic and Doppler studies
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 weeks
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Preterm infants ≤32 weeks gestational age, regardless their weight with postnatal age 3-6 weeks.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
Alexandria, 21131
About this study
Official title: Effect of Anemia of Prematurity and Its Treatment on Hemodynamics of Preterm Infants
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.
Read the 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.
- Conditions
- Premature
- Being tested
- Echocardiographic and Doppler studies
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiographic and Doppler studiesRadiation
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:
| Study group | Role | What they receive |
|---|---|---|
| Group I | (anemic group) Receives: Radiation: Echocardiographic and Doppler studies | |
| Group II | (non-anemic group) Receives: Radiation: Echocardiographic and Doppler studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.(
Measured: 3-6 weeks postnatal age
2. Cerebral blood flow velocities
in the anterior cerebral artery through the anterior fontanelle in the sagittal plane
Measured: 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.
Measured: 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.
Measured: 3-6 weeks postnatal age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Jul 2021
- Primary completion1 Feb 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marwa Mohamed Farag
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marwa Mohamed Farag, Alexandria University
- Investigators
- Ahmed Adel El Beheiry, PhD, Study chair, Faculty of medicine, Alexandria University, EgyptAmany Tolba Elsebaee, MBBCh, Principal investigator, Faculty of medicine, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496400
- Sponsor's protocol ID
- 0106769
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anemia of Prematurity and Its Treatment on Hemodynamics of Preterm Infants
- ClinicalTrials.gov ID
- NCT05496400
- Acronym / sponsor ID
- 0106769
- Conditions
- Premature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Marwa Mohamed FaragUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Radiation: Echocardiographic and Doppler studies(anemic group) |
| Group II | – | Radiation: Echocardiographic and Doppler studies(non-anemic group) |
Who may qualify
- Ages
- 3 to 6 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Preterm infants ≤32 weeks gestational age, regardless their weight with postnatal age 3-6 weeks.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiographic and Doppler studiesEchographic 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: | Radiation | Group I, Group II |
Primary outcome
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. 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. 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.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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Adel El Beheiry, PhD study chair
Faculty of medicine, Alexandria University, Egypt
Amany Tolba Elsebaee, MBBCh principal investigator
Faculty of medicine, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature, run by Marwa Mohamed Farag at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Cardiac output: (time frame: 3-6 weeks postnatal age). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.