AzTrials
AzTrials

Red Blood CellsNCT05331235

Blood Transfusions in Preterm Infants

An observational study of Red Blood Cells and Preterm, run by Kasr El Aini Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

A cross sectional study to assess the effect of blood transfusions on the outcome of preterm infants Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Red Blood Cells, Preterm
How many people
40 participants
Where
No sites listed yet
Study dates
1 May 2022to 1 Jan 2023
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Preterm infants admitted to the "grower ward", directly after birth or after transfer from NICU

Who may be able to join

  • Grower preterm infants

Who cannot join

  • Severe illness, Hypovolemic shock, Hypoxia, Oxygen therapy, Surgical intervention

Trial locations and contacts

No sites are listed yet.

Douaa El Sherbiny, MD contact

01000039725

doaa.sherbiny@gmail.com

About this study

Official title: Effect of Blood Transfusions on the Outcome of Low Birth Weight Preterm Infants

A cross sectional study to assess the effect of blood transfusions on the outcome of preterm infants

Read the detailed description

This is a cross sectional study carried on preterm infants who are staying in the hospital as "growers"; to gain weight. We will assess blood transfusion received by these preterm infants in details.

Medical subject headings
Premature Birth

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in heart rate

    Heart rate per minute

    Measured: immediately before and immediately after blood transfusion

  2. Change in respiratory rate

    Respiratory rate per minute

    Measured: immediately before and immediately after blood transfusion

  3. Change in weight gain

    Average weight gain in grams/kg/day

    Measured: within 4 days before and within 4 days after blood transfusion

  4. Change in hemoglobin

    Hemoglobin in grams/dl

    Measured: immediately before and immediately after blood transfusion

  5. Change in hematocrit value

    Hematocrit value percentage

    Measured: immediately before and immediately after blood transfusion

Secondary outcomes (12)

  1. Acute blood loss

    Acute blood loss either spontaneous or iatrogenic during invasive procedures

    Measured: in the previous 24 hours before blood transfusion

  2. Mechanical ventilation

    Mechanical ventilation (MV) which may be one of two possibilities:

    1. Moderate or significant MV; Mean airway pressure (MAP) >8 cm H2O on conventional ventilator or >14 cm H2O on high frequency ventilator and FiO2 >0.4
    2. Minimal MV; MAP ≤8 cmH2O on conventional ventilator or ≤14 cm H2O on high frequency ventilator and FiO2 ≤ 0.4

    Measured: in the previous 24 hours before blood transfusion

  3. Supplemental oxygen

    Supplemental oxygen, not mechanically ventilated

    Measured: in the previous 24 hours before blood transfusion

  4. Doubling of oxygen requirements

    Doubling of oxygen requirements for patients on supplemental oxygen

    Measured: in the previous 2 days before blood transfusion

  5. Tachycardia

    ≥24 hours of tachycardia (Heart rate>180/minute)

    Measured: in the previous 24 hours before blood transfusion

  6. Tachypnea

    ≥24 hours of tachypnea (Respiratory rate>60/minute),

    Measured: in the previous 24 hours before blood transfusion

  7. Poor weight gain

    ≤10 g/kg/day while the infant is receiving ≥120 kcal/kg/day

    Measured: in the previous 4 days before blood transfusion

  8. Metabolic acidosis

    pH <7.2

    Measured: in the previous 24 hours before blood transfusion

  9. Apnea and bradycardia

    9 episodes or ≥2 episodes requiring bag and mask ventilation, while infant is receiving caffeine citrate

    Measured: in the previous 24 hours before blood transfusion

  10. Length of stay in the NICU

    Length of stay in the NICU

    Measured: from date of birth until the date of transfer to the "grower ward" or date of death from any cause, whichever came first, assessed up to 3 months.

  11. Length of stay in the hospital

    Length of stay in the hospital

    Measured: from date of birth until the date of discharge home or date of death from any cause, whichever came first, assessed up to 3 months.

  12. Mortality

    Death

    Measured: from the date of transfer to grower ward, assessed up to 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2022
  2. Study start1 May 2022 (estimated)
  3. Primary completion1 Nov 2022 (estimated)
  4. Study completion1 Jan 2023 (estimated)

Resources

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 only
Time perspective
Cross-sectional
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05331235
Sponsor's protocol ID
MS-49-2020
Status last verified
Apr 2022
First submitted
20 Mar 2022
Last updated
15 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Red Blood Cells and Preterm, run by Kasr El Aini Hospital.

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: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Douaa El Sherbiny, MD (01000039725, doaa.sherbiny@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in heart rate (time frame: immediately before and immediately after blood transfusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05331235.

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 15 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in