IgM-Enriched Immunoglobulin for Neonatal Sepsis

Efficacy of Prophylactic IgM-Enriched Immunoglobulin for the Management of Early-Onset Neonatal Sepsis in Very Low Birth Weight Preterm Neonates; A Randomized Controlled Trial

Sponsors

Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

Source Fakultas Kedokteran Universitas Indonesia
Brief Summary

This study compares giving prophylactic IgM enriched Intravenous Immunoglobulin (IVIG) with placebo in 1 hour after birth, in neonates with risk factors of Early-Onset Neonatal Sepsis (EONS). In addition to the intervention, standard regimen antibiotics are also given within 1 hour. The IVIG is given for 3 days and primary and secondary outcomes will be collected. Risk factors are both from maternal and neonate origin.

Detailed Description

This randomized-controlled trial conducted in Cipto Mangunkusumo Hospital, Jakarta, Indonesia aims to determine the efficacy of prophylactic IgM-Enriched IVIG in preventing EONS. A total of 70 very low birth weight (VLBW) neonates with risk factors for EONS including maternal factors of premature rupture of membrane (PROM), fever, urinary tract infection (UTI), chorioamnionitis, and neonatal factor of prematurity and resuscitation history will be collected. These neonates within 1 hour of life will then be administered either placebo or IgM-enriched IVIG 0.25g/kg/day for 3 days, in addition to first-line empiric antibiotic. Randomization is done using simple randomization. Triple masking (Participant, Investigator, Outcomes Assessor) is conducted.

These neonates will then be clinically observed and evaluated for early mortality (mortality below 7 days), hemodynamics, length of stay, blood culture results, C-Reactive Protein (CRP), IT ratio, routine hematological examination, and IgGAME as parameters of improvement and prevention of EONS.

STATA version 12 (Macintosh version) will be used for data management and statistical analyses. The variables will first be presented descriptively, continued with bivariate and multivariate analysis. Bivariate analysis will be conducted between independent and dependent variables using chi-square/Fisher's exact test, Student's t-test, and Kruskal-Wallis. Variables with p-values <0.25 will be included in the multivariate analysis using logistic regression. The investigators will use two-sided p-values in our analysis with a p < 0.05 level of significance.

Overall Status Not yet recruiting
Start Date September 2019
Completion Date August 2020
Primary Completion Date June 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Early Mortality Rate 1 week
Secondary Outcome
Measure Time Frame
Positive blood culture 1 week
Duration of NICU stay Through study completion, an average of 3 months
Quantitative CRP Levels 1 week
IT Ratio value 1 week
Leukocyte count 1 week
IgGAME (IgG, IgM, IgA, IgE) Levels 1 week
Enrollment 70
Condition
Intervention

Intervention Type: Drug

Intervention Name: IgM-enriched IVIG

Description: Contains human plasma protein 50mg/ml. With composition of Immunoglobulin M (IgM) 6mg, Immunoglobulin A (IgA) 6mg, Immunoglobulin G (IgG) 38mg (IgG subcl. approx. 63 % IgG1, 26 % IgG2, 4 % IgG3 and 7 % IgG4), Glucose monohydrate, sodium chloride, water for injections

Other Name: Pentaglobin®

Eligibility

Criteria:

Inclusion Criteria:

- Very low birth weight infants (< 1500 g)

- Gestational age below 32 weeks

- Risk of Early-Onset sepsis from maternal and neonate factors

- Inborn neonates

Exclusion Criteria:

- Birth weight < 600 g

- Gestational age < 26 weeks

- Multiple Congenital Anomaly

- Neonates with suspected congenital syndrome

Gender: All

Minimum Age: N/A

Maximum Age: 1 Hour

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Rinawati Rohsiswatmo, MD, PhD

Phone: +62811133094

Email: [email protected]

Verification Date

July 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Fakultas Kedokteran Universitas Indonesia

Investigator Full Name: Rinawati

Investigator Title: Principal Investigator; Senior Clinical Staff of Perinatology Division, Department of Child Health, Cipto Mangunkusumo Hospital; Head of Kiara Center of Maternal and Child Health, Cipto Mangunkusumo Hospital

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Treatment Group

Type: Experimental

Description: IgM-enriched IVIG given with dose of 0.25g/kg over 3 hours for 3 days in addition to Antibiotics

Label: Placebo Group

Type: Placebo Comparator

Description: Antibiotics only

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov