NCT05331235

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

March 20, 2022

Last Update Submit

April 14, 2022

Conditions

Red Blood CellsPreterm

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (12)

  • Acute blood loss

    in the previous 24 hours before blood transfusion

  • Mechanical ventilation

    in the previous 24 hours before blood transfusion

  • Supplemental oxygen

    in the previous 24 hours before blood transfusion

  • Doubling of oxygen requirements

    in the previous 2 days before blood transfusion

  • Tachycardia

    in the previous 24 hours before blood transfusion

  • +7 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Preterm infants admitted to the "grower ward", directly after birth or after transfer from NICU

You may qualify if:

  • Grower preterm infants

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: NONE RETAINED

blood samples

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Dahlia El Sebaie, MD

    Kasralainy hospital, Faculty of medicine, Cairo University

    STUDY DIRECTOR

Central Study Contacts

Douaa El Sherbiny, MD

CONTACT

01000039725doaa.sherbiny@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Pediatrics, Cairo university

Study Record Dates

First Submitted

March 20, 2022

First Posted

April 15, 2022

Study Start

May 1, 2022

Primary Completion

November 1, 2022

Study Completion

January 1, 2023

Last Updated

April 15, 2022

Record last verified: 2022-04