Preterm Clinical Trial
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
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Kasr El Aini Hospital |
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. |
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