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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04041765
Other study ID # 19-11-432
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date September 2019
Est. completion date August 2020

Study information

Verified date July 2019
Source Fakultas Kedokteran Universitas Indonesia
Contact Rinawati Rohsiswatmo, MD, PhD
Phone +62811133094
Email rinarohsis@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date August 2020
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Hour
Eligibility 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

Study Design


Intervention

Drug:
IgM-enriched IVIG
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fakultas Kedokteran Universitas Indonesia

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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 (ELBW) with sepsis: a retrospective cohort study. Minerva Pediatr. 2018 Feb 19. doi: 10.23736/S0026-4946.18.04850-8. [Epub ahead of print] — View Citation

Haque KN, Zaidi MH, Bahakim H. IgM-enriched intravenous immunoglobulin therapy in neonatal sepsis. Am J Dis Child. 1988 Dec;142(12):1293-6. — View Citation

Reith HB, Rauchschwalbe SK, Mittelkötter 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Early Mortality Rate Neonates in the treatment group should have lower mortality rate in the first week of life 1 week
Secondary Positive blood culture Neonates in the treatment group should have less number of positive blood culture than those in the place group 1 week
Secondary Duration of NICU stay Neonates in the treatment group should be discharged earlier than those in the placebo group Through study completion, an average of 3 months
Secondary Quantitative CRP Levels Neonates in the treatment group should have lower CRP levels than those in the placebo group 1 week
Secondary IT Ratio value Neonates in the treatment group should have lower IT Ratio value than those in the placebo group 1 week
Secondary Leukocyte count Neonates in the treatment group should have lower Leukocyte count than those in the placebo group 1 week
Secondary IgGAME (IgG, IgM, IgA, IgE) Levels Neonates in the treatment group should have higher IgGAME levels than those in the placebo group 1 week
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