Blood Transfusions in Preterm Infants

April 14, 2022 updated by: Douaa El Saied El Sherbiny, Kasr El Aini Hospital

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Grower preterm infants

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in heart rate
Time Frame: immediately before and immediately after blood transfusion
Heart rate per minute
immediately before and immediately after blood transfusion
Change in respiratory rate
Time Frame: immediately before and immediately after blood transfusion
Respiratory rate per minute
immediately before and immediately after blood transfusion
Change in weight gain
Time Frame: within 4 days before and within 4 days after blood transfusion
Average weight gain in grams/kg/day
within 4 days before and within 4 days after blood transfusion
Change in hemoglobin
Time Frame: immediately before and immediately after blood transfusion
Hemoglobin in grams/dl
immediately before and immediately after blood transfusion
Change in hematocrit value
Time Frame: immediately before and immediately after blood transfusion
Hematocrit value percentage
immediately before and immediately after blood transfusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute blood loss
Time Frame: in the previous 24 hours before blood transfusion
Acute blood loss either spontaneous or iatrogenic during invasive procedures
in the previous 24 hours before blood transfusion
Mechanical ventilation
Time Frame: in the previous 24 hours before blood transfusion

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
in the previous 24 hours before blood transfusion
Supplemental oxygen
Time Frame: in the previous 24 hours before blood transfusion
Supplemental oxygen, not mechanically ventilated
in the previous 24 hours before blood transfusion
Doubling of oxygen requirements
Time Frame: in the previous 2 days before blood transfusion
Doubling of oxygen requirements for patients on supplemental oxygen
in the previous 2 days before blood transfusion
Tachycardia
Time Frame: in the previous 24 hours before blood transfusion
≥24 hours of tachycardia (Heart rate>180/minute)
in the previous 24 hours before blood transfusion
Tachypnea
Time Frame: in the previous 24 hours before blood transfusion
≥24 hours of tachypnea (Respiratory rate>60/minute),
in the previous 24 hours before blood transfusion
Poor weight gain
Time Frame: in the previous 4 days before blood transfusion
≤10 g/kg/day while the infant is receiving ≥120 kcal/kg/day
in the previous 4 days before blood transfusion
Metabolic acidosis
Time Frame: in the previous 24 hours before blood transfusion
pH <7.2
in the previous 24 hours before blood transfusion
Apnea and bradycardia
Time Frame: in the previous 24 hours before blood transfusion
9 episodes or ≥2 episodes requiring bag and mask ventilation, while infant is receiving caffeine citrate
in the previous 24 hours before blood transfusion
Length of stay in the NICU
Time Frame: 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.
Length of stay in the NICU
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.
Length of stay in the hospital
Time Frame: 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.
Length of stay in the hospital
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.
Mortality
Time Frame: from the date of transfer to grower ward, assessed up to 3 months.
Death
from the date of transfer to grower ward, assessed up to 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kasr El Aini Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dahlia El Sebaie, MD, Kasralainy hospital, faculty of medicine, Cairo university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MS-49-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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