Blood Transfusions in Preterm Infants

Preterm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05331235
• Other study ID #: MS-49-2020
• Status: Not yet recruiting
• Start date: May 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: April 2022
• Source: Kasr El Aini Hospital
• Contact: Douaa El Sherbiny, MD
• Phone: 01000039725
• Email: doaa.sherbiny[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 1, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Grower preterm infants

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm
• Red Blood Cells

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart rate	Heart rate per minute	immediately before and immediately after blood transfusion
Primary	Change in respiratory rate	Respiratory rate per minute	immediately before and immediately after blood transfusion
Primary	Change in weight gain	Average weight gain in grams/kg/day	within 4 days before and within 4 days after blood transfusion
Primary	Change in hemoglobin	Hemoglobin in grams/dl	immediately before and immediately after blood transfusion
Primary	Change in hematocrit value	Hematocrit value percentage	immediately before and immediately after blood transfusion
Secondary	Acute blood loss	Acute blood loss either spontaneous or iatrogenic during invasive procedures	in the previous 24 hours before blood transfusion
Secondary	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
Secondary	Supplemental oxygen	Supplemental oxygen, not mechanically ventilated	in the previous 24 hours before blood transfusion
Secondary	Doubling of oxygen requirements	Doubling of oxygen requirements for patients on supplemental oxygen	in the previous 2 days before blood transfusion
Secondary	Tachycardia	=24 hours of tachycardia (Heart rate>180/minute)	in the previous 24 hours before blood transfusion
Secondary	Tachypnea	=24 hours of tachypnea (Respiratory rate>60/minute),	in the previous 24 hours before blood transfusion
Secondary	Poor weight gain	=10 g/kg/day while the infant is receiving =120 kcal/kg/day	in the previous 4 days before blood transfusion
Secondary	Metabolic acidosis	pH <7.2	in the previous 24 hours before blood transfusion
Secondary	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
Secondary	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.
Secondary	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.
Secondary	Mortality	Death	from the date of transfer to grower ward, assessed up to 3 months.