Efficacy of Intravenous Immunoglobulin in Management of Rh and ABO Incompatibility Disease

NCT03130517 | Unknown Early Phase 1 DMC

• 1 other identifier: assuit university 66
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

hemolytic disease of newborn is an important cause of hyperbilirubinemia with significant morbidity and mortality in neonatal period. intravenous immunoglobulin has widely used in management of hemolytic disease of new born

Conditions

Haemolysis Neonatal

Keywords

hemolysis,newborn

Outcome Measures

Primary Outcomes (1)

• To measure duration of phototherapy

  to measure how many neonate need for exchange transfusion after one dose of intravenous immunoglobulin and reduction of haemolysis rate which is estimated by reduction in reticulocytic count

  Two days

Secondary Outcomes (1)

• duration of hospital stay

  Four days

Study Arms (2)

Intervention group

OTHER

Use of single dose of intravenous immunoglobulin in a dose 0.5\_1gm /kg to intervention group

Drug: intravenous immunoglobulin

Control group

OTHER

Control group will recieve phototherapy only

Drug: intravenous immunoglobulin

Interventions

intravenous immunoglobulin DRUG

giving intravenous immunoglobulin to neonates included in inclusion criteria in a dose of 0.5-1 gm

Also known as: gammaglobulin

Control group; Intervention group

Eligibility Criteria

• Age: 48 Hours - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• )Gestational age more than or equal 37 weeks and postnatal age from 48hr-72hr.
• )Anemia with Reticulocytic count 10% 3)Serum total bilirubin around 18mg/dl .

You may not qualify if:

• )perinatal asphyxia. 2)Congenital malformation. 3)Severe respiratory distress. 4)Sepsis during hospital stay. 5)Metabolic problems . 6)Gestational age less than 37 weeks

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Hemolysis

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: intervention group will recieve intravenous immunoglobulin and phototherapy and control group that will receive phototherapy only

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 26, 2017
• Study Start: July 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: June 27, 2017

Record last verified: 2017-06