IgM-Enriched Immunoglobulin for Neonatal Sepsis

NCT04041765 | Unknown Phase 3 DMC

• 1 other identifier: 19-11-432
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neonatal Sepsis, Early-Onset; Very Low Birth Weight Infant; Inflammation; Infant, Newborn, Disease

Keywords

IgM-enriched Intravenous Immunoglobulin

Outcome Measures

Primary Outcomes (1)

• Early Mortality Rate

  Neonates in the treatment group should have lower mortality rate in the first week of life

  1 week

Secondary Outcomes (6)

• 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

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Drug: IgM-enriched IVIG

Placebo Group

PLACEBO COMPARATOR

Antibiotics only

Drug: IgM-enriched IVIG

Interventions

IgM-enriched IVIG DRUG

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

Also known as: Pentaglobin®

Placebo Group; Treatment Group

Eligibility Criteria

• Age: 1 Minute - 1 Hour
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Very low birth weight infants (\< 1500 g)
• Gestational age below 32 weeks
• Risk of Early-Onset sepsis from maternal and neonate factors
• Inborn neonates

You may not qualify if:

• Birth weight \< 600 g
• Gestational age \< 26 weeks
• Multiple Congenital Anomaly
• Neonates with suspected congenital syndrome

Sponsors & Collaborators

• Fakultas Kedokteran Universitas Indonesia: lead

Related Publications (5)

• Capasso L, Borrelli AC, Parrella C, Lama S, Ferrara T, Coppola C, Catania MR, Iula VD, Raimondi F. Are IgM-enriched immunoglobulins an effective adjuvant in septic VLBW infants? Ital J Pediatr. 2013 Oct 7;39:63. doi: 10.1186/1824-7288-39-63.

  PMID: 24098953 BACKGROUND

• Haque KN, Zaidi MH, Bahakim H. IgM-enriched intravenous immunoglobulin therapy in neonatal sepsis. Am J Dis Child. 1988 Dec;142(12):1293-6. doi: 10.1001/archpedi.1988.02150120047038.

  PMID: 3195529 BACKGROUND

• Reith HB, Rauchschwalbe SK, Mittelkotter U, Engemann R, Thiede A, Arnold A, Lissner R. IgM-enriched immunoglobulin (pentaglobin) positively influences the course of post-surgical intra-abdominal infections. Eur J Med Res. 2004 Oct 29;9(10):479-84.

  PMID: 15546815 BACKGROUND

• Capasso L, Borrelli AC, Pirozzi MR, Bucci L, Albachiara R, Ferrara T, Raimondi F. IgM and IgA enriched polyclonal immunoglobulins reduce short term mortality in extremely low birth weight infants with sepsis: a retrospective cohort study. Minerva Pediatr (Torino). 2021 Feb;73(1):3-7. doi: 10.23736/S2724-5276.18.04850-8. Epub 2018 Feb 19.

  PMID: 29460549 BACKGROUND

• Capasso L, Borrelli AC, Ferrara T, Coppola C, Cerullo J, Izzo F, Caiazza R, Lama S, Raimondi F. Immunoglobulins in neonatal sepsis: has the final word been said? Early Hum Dev. 2014 Sep;90 Suppl 2:S47-9. doi: 10.1016/S0378-3782(14)50013-8.

  PMID: 25220128 BACKGROUND

MeSH Terms

Conditions

Neonatal Sepsis; Inflammation; Disease

Interventions

pentaglobulin

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rinawati Rohsiswatmo, MD, PhD

  Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital

  STUDY CHAIR

• Nina D Putri, MD, PhD

  Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rinawati Rohsiswatmo, MD, PhD

CONTACT

+62811133094; rinarohsis@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI 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

Study Record Dates

• First Submitted: July 27, 2019
• First Posted: August 1, 2019
• Study Start: September 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 1, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share