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Randomized Controlled Trial
. 2021 Sep-Oct;53(5):364-370.
doi: 10.4103/ijp.ijp_881_20.

Pentaglobin (immunoglobulin M-enriched immunoglobulin) as adjuvant therapy for premature and very low-birth-weight neonates with sepsis

Kawthar F Nassir  1 , Yasir Ibrahim Al-Saddi  2 , Hassan M Abbas  3 , Qutaiba Ahmed Al Khames Aga  4 , Luma Ahmed Al Khames Aga  5 , Ameer A Oudah  6
Affiliations
Randomized Controlled Trial

Pentaglobin (immunoglobulin M-enriched immunoglobulin) as adjuvant therapy for premature and very low-birth-weight neonates with sepsis

Kawthar F Nassir et al. Indian J Pharmacol. 2021 Sep-Oct.

Abstract

Objectives: The purpose of this research was to determine the effectiveness of Pentaglobin® as adjuvant therapy in the treatment of sepsis in preterm newborns.

Materials and methods: It was a prospective, observational, randomized study for 272 premature neonates and very low birth weight (VLBW) that were diagnosed with sepsis carried at neonatal intensive care units. The patients randomized into control group who received standard sepsis antibiotic treatments, and an intervention group who received Pentaglobin® 5 ml/kg daily for 3 consecutive days as an adjunct therapy to a standard sepsis antibiotic treatment.

Results: Multiple organisms that isolated from culture specimens were Gram-negative bacteria, Gram-positive, and candida (56.25%, 42.28%, and 1.47%, respectively). The disease duration was distinctively longer in patients who were treated by the standard antibiotic protocol (mean ± standard deviation [SD]: 30.76 ± 3.97, odds ratio [OR]: 30.76, 95% confidence interval [CI]: 30.051, 31.473) comparing to the patients who received Pentaglobin adjuvant therapy (mean ± SD: 26.48 ± 5.55, OR: 26.48, 95% CI: 25.489, 27.477) (P < 0.000). Patients treated by standard antibiotic protocol were associated to a substantially increased risk of death (11.76%, hazard ratio 4.400, 95% CI: 1.432, 13.529, P = 0.009).

Conclusion: Neonatal sepsis is more common in premature and VLBW newborns, and Pentaglobin® management of newborn nosocomial sepsis might be used in addition to other therapies.

Keywords: Immunoglobulin M-enriched immunoglobulin; neonate; premature; sepsis; very low birth weight.

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Figures

Figure 1
Figure 1
The time-dependent effect of reaching the composite end-points
Figure 2
Figure 2
Hospital stay and mortality rate between groups
Figure 3
Figure 3
Predictors of Mortality Univariate
Figure 4
Figure 4
Predictors of Mortality Multivariate
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