NCT05134792

Brief Summary

Effect of pre-emptive intravenous immunoglobulin administration on the incidence of septic episodes in pediatric burn patients: A randomized controlled study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 10, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 2, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2022

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

9 months

First QC Date

November 2, 2021

Last Update Submit

November 13, 2022

Conditions

Burn Shock

Outcome Measures

Primary Outcomes (1)

  • Incidence of sepsis during ICU stay will be recorded.

    Sepsis is defined by clinical criteria (temperature more than 38.9 °C, leukocytosis, thrombocytopenia, glucose intolerance, and/or new onset of ileus) and/or the presence of a positive blood culture in association with clinical signs of infection/sepsis. An increase in Procalcitonin level will be also used as an early laboratory marker for sepsis.

    Through out study completion, average 30 days.

Secondary Outcomes (6)

  • Incidence of septic shock

    Through out study completion, average 30 days.

  • Number of septic episodes

    Throughout the study completion average 30 days.

  • Length of stay

    Through out study completion, average 30 day.

  • PEdiatric Logistic Organ Dysfunction score 2 (PELOD-2)

    Through out study completion, average 30 days

  • Mortality rate

    30 days

  • +1 more secondary outcomes

Other Outcomes (16)

  • serum Procalcitonin

    Day 1 ,Day3 ,and on each incidence of sepsis, and through out study completion, average 30 days .

  • serum IgG

    Day 1 and Day 7.

  • serum C-reactive protein

    Day 1 , and on each incidence of sepsis, assessed up to 30 days.

  • +13 more other outcomes

Study Arms (2)

No intravenous immunoglobulin (IVIG)

NO INTERVENTION

The control group are burn patients with inclusion criteria that did not receive IVIG.

Intravenous immunoglobulin (IVIG) group

EXPERIMENTAL

Pediatric burn patients between 1and 5 years with 10% or greater burn area of TBSA within 24 hours of onset of burn will receive intravenous immunoglobulin.

Drug: intravenous immunoglobulin

Interventions

intravenous immunoglobulinDRUG

All pediatric burn patients allocated in group intra venous immunoglobulin admitted will receive 200 mg/kg IVIG once after their initial resuscitation before 48 hours passes of burn incident.

Also known as: LIV GAMMA "S/D treated Human Immunoglobulin "2.5 grams/50 ml
Intravenous immunoglobulin (IVIG) group

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All burn patients 1 to 5 years old with 10% or greater burn area of TBSA .

You may not qualify if:

  • Patients with septic shock (evidence of infection and inotropes) .
  • Burns more than 48 hours duration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (3)

  • Galal NM. Pattern of intravenous immunoglobulins (IVIG) use in a pediatric intensive care facility in a resource limited setting. Afr Health Sci. 2013 Jun;13(2):261-5. doi: 10.4314/ahs.v13i2.9.

    PMID: 24235922RESULT

  • Lyons JM, Davis C, Rieman MT, Kopcha R, Phan H, Greenhalgh D, Palmieri T, Kagan R. Prophylactic intravenous immune globulin and polymixin B decrease the incidence of septic episodes and hospital length of stay in severely burned children. J Burn Care Res. 2006 Nov-Dec;27(6):813-8. doi: 10.1097/01.BCR.0000245421.54312.36.

    PMID: 17091076RESULT

  • Munster AM, Hoagland HC, Pruitt BA Jr. The effect of thermal injury on serum immunoglobulins. Ann Surg. 1970 Dec;172(6):965-9. doi: 10.1097/00000658-197012000-00006. No abstract available.

    PMID: 5496482RESULT

MeSH Terms

Interventions

Immunoglobulins, Intravenous

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Hanan Mostafa

    lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia ,surgical intensive care and Pain .

Study Record Dates

First Submitted

November 2, 2021

First Posted

November 26, 2021

Study Start

October 10, 2021

Primary Completion

July 16, 2022

Study Completion

July 16, 2022

Last Updated

November 15, 2022

Record last verified: 2022-11

Locations

EG(1)