Blood Transfusions in Preterm Infants

• Conditions: Red Blood Cells; Preterm

• Registration Number: NCT05331235
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-03-20
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-14
• Last Update Submitted: 2022-04-14
• Study First Posted: 2022-04-15
• Last Update Posted: 2022-04-15
• Study Start: 2022-05-01
• Primary Completion: 2022-11-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Grower preterm infants

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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