Blood Transfusions in Preterm Infants

Sponsor
Kasr El Aini Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05331235
Collaborator
(none)
40
8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Effect of Blood Transfusions on the Outcome of Low Birth Weight Preterm Infants
    Anticipated Study Start Date :
    May 1, 2022
    Anticipated Primary Completion Date :
    Nov 1, 2022
    Anticipated Study Completion Date :
    Jan 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Change in heart rate [immediately before and immediately after blood transfusion]

      Heart rate per minute

    2. Change in respiratory rate [immediately before and immediately after blood transfusion]

      Respiratory rate per minute

    3. Change in weight gain [within 4 days before and within 4 days after blood transfusion]

      Average weight gain in grams/kg/day

    4. Change in hemoglobin [immediately before and immediately after blood transfusion]

      Hemoglobin in grams/dl

    5. Change in hematocrit value [immediately before and immediately after blood transfusion]

      Hematocrit value percentage

    Secondary Outcome Measures

    1. Acute blood loss [in the previous 24 hours before blood transfusion]

      Acute blood loss either spontaneous or iatrogenic during invasive procedures

    2. Mechanical ventilation [in the previous 24 hours before blood transfusion]

      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

    3. Supplemental oxygen [in the previous 24 hours before blood transfusion]

      Supplemental oxygen, not mechanically ventilated

    4. Doubling of oxygen requirements [in the previous 2 days before blood transfusion]

      Doubling of oxygen requirements for patients on supplemental oxygen

    5. Tachycardia [in the previous 24 hours before blood transfusion]

      ≥24 hours of tachycardia (Heart rate>180/minute)

    6. Tachypnea [in the previous 24 hours before blood transfusion]

      ≥24 hours of tachypnea (Respiratory rate>60/minute),

    7. Poor weight gain [in the previous 4 days before blood transfusion]

      ≤10 g/kg/day while the infant is receiving ≥120 kcal/kg/day

    8. Metabolic acidosis [in the previous 24 hours before blood transfusion]

      pH <7.2

    9. 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

    10. 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

    11. 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

    12. Mortality [from the date of transfer to grower ward, assessed up to 3 months.]

      Death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Grower preterm infants
    Exclusion Criteria:
    • Severe illness, Hypovolemic shock, Hypoxia, Oxygen therapy, Surgical intervention

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Kasr El Aini Hospital

    Investigators

    • Study Director: Dahlia El Sebaie, MD, Kasralainy hospital, Faculty of medicine, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Douaa El Saied El Sherbiny, Lecturer of Pediatrics, Cairo university, Kasr El Aini Hospital
    ClinicalTrials.gov Identifier:
    NCT05331235
    Other Study ID Numbers:
    • MS-49-2020
    First Posted:
    Apr 15, 2022
    Last Update Posted:
    Apr 15, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 15, 2022