Blood Transfusions in Preterm Infants

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: Not yet recruiting
• Conditions: Preterm; Red Blood Cells

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: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Douaa El Sherbiny, MD; Phone Number: 01000039725; Email: doaa.sherbiny@gmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate	Heart rate per minute	immediately before and immediately after blood transfusion
Change in respiratory rate	Respiratory rate per minute	immediately before and immediately after blood transfusion
Change in weight gain	Average weight gain in grams/kg/day	within 4 days before and within 4 days after blood transfusion
Change in hemoglobin	Hemoglobin in grams/dl	immediately before and immediately after blood transfusion
Change in hematocrit value	Hematocrit value percentage	immediately before and immediately after blood transfusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute blood loss	Acute blood loss either spontaneous or iatrogenic during invasive procedures	in the previous 24 hours before blood transfusion
Mechanical ventilation	Mechanical ventilation (MV) which may be one of two possibilities: 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; 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	Supplemental oxygen, not mechanically ventilated	in the previous 24 hours before blood transfusion
Doubling of oxygen requirements	Doubling of oxygen requirements for patients on supplemental oxygen	in the previous 2 days before blood transfusion
Tachycardia	≥24 hours of tachycardia (Heart rate>180/minute)	in the previous 24 hours before blood transfusion
Tachypnea	≥24 hours of tachypnea (Respiratory rate>60/minute),	in the previous 24 hours before blood transfusion
Poor weight gain	≤10 g/kg/day while the infant is receiving ≥120 kcal/kg/day	in the previous 4 days before blood transfusion
Metabolic acidosis	pH <7.2	in the previous 24 hours before blood transfusion
Apnea and bradycardia	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	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	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	Death	from the date of transfer to grower ward, assessed up to 3 months.

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Study Director: Dahlia El Sebaie, MD, Kasralainy hospital, faculty of medicine, Cairo university

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: March 20, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID 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