A Randomized Case-Controlled Study of Recombinant Human Granulocyte Colony Stimulating Factor for the Treatment of Sepsis in Preterm Neutropenic Infants

Aktaş, Doğukan; Demirel, Bilge; Gürsoy, Tuğba; Ovalı, Fahri

doi:10.1016/j.pedneo.2014.06.007

Cited by 17 publications

(12 citation statements)

References 24 publications

(12 reference statements)

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“…One should keep in mind that resistance to G-CSF in NAIN associated with anti-HNA-2 antibodies, possibly due to a G-CSF-induced increase of HNA-2 expression on the neutrophils, has been described [63,64,65]. Despite the stimulated production of neutrophils, controversial results on the benefit of G-CSF in terms of infection-free survival have been published [66,67,68,69,70]. …”

Section: Treatmentmentioning

confidence: 99%

Neonatal Alloimmune Neutropenia

Porcelijn

Haas

2018

Transfus Med Hemother

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Neonatal alloimmune neutropenia (NAIN, NAIN or NIN) is a neutrophil blood group antagonism, analogous to hemolytic disease of the fetus and newborn (HDFN) and fetal/neonatal alloimmune thrombocytopenia (FNAIT). A limited number of prospective screening studies showed that granulocyte-specific antibodies were detectable in 0.35-1.1% of random postnatal maternal samples and that the incidence of NAIN was below 0.1%. Symptoms vary from none to mild skin infections, omphalitis or more severe infections like pneumonia, sepsis, and meningitis. Treatment of neonatal infection with antibiotics and granulocyte-colony stimulating factor is advised.

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Section: Treatmentmentioning

confidence: 99%

Neonatal Alloimmune Neutropenia

Porcelijn

Haas

2018

Transfus Med Hemother

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“…The positive contribution of rhG-CSF to neonatal sepsis as well as neutropenia has been studied in various studies (30,(38)(39)(40). In this study, it was indicated that rhG-CSF was associated with considerable improvements in the number of WBC and ANC, while no significant changes were observed in the serum level of hs-CRP and immature/total neutrophil ratio.…”

Section: Discussionmentioning

confidence: 82%

“…The use of rG-CSF declined nosocomial infections over the subsequent 2 weeks (28). Likewise, Aktas et al showed that treatment with rhG-CSF (10 µg/kg/day; 1 -4 days, median, 2 days) was associated with an outstanding recovery of the ANC in neutropenic (ANC < 1.0 × 10 9 /L) preterm infants with sepsis and short-term mortality remained unchanged in their study (38). In the study conducted by Borjianyazdi et al in Iran, the effectiveness of G-CSF (10 µg/kg for up to 5 consecutive days) was evaluated clinically in preterm infants with sepsis and neutropenia (ANC ≤ 5000/µL).…”

Section: Discussionmentioning

confidence: 84%

Clinical and Biochemical Effects of Recombinant Human Granulocyte Colony-Stimulating Factor on the Prognosis of Preterm Infants with Early Onset Neonatal Sepsis

Saeidi¹,

Akhavan²,

Tavakkol‐Afshari³

et al. 2019

Arch Pediatr Infect Dis

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Background: A double-blind, placebo-controlled randomized trial was designed to investigate the effects of recombinant human granulocyte colony-stimulating factor (rhG-CSF) on the prognosis of preterm infants with early onset neonatal sepsis (EONS). Methods: Fifty preterm infants were selected from the neonatal intensive care unit (NICU) of Qaem Hospital, Mashhad, Iran in 2011. They were randomized to rhG-CSF (intervention group, n = 25) or identical placebo (control group, n = 25) for 3 days. The following blood parameters were measured: White blood cells count (WBC), absolute neutrophil count (ANC), serum level of highsensitivity C-reactive protein (hs-CRP), and the ratio of immature to total neutrophils. In addition, the mortality rate, adverse effects, and duration of hospital stay were evaluated as clinical parameters. Results: At baseline, both groups were not significantly different (P > 0.05) except for the hs-CRP level (P = 0.024) and hypoglycemia (P = 0.001). Compared with the controls, significant improvements were only observed in WBC (P = 0.001) and ANC (P = 0.010) of the intervention group. The mean difference in the WBC, ANC, hs-CRP level, and the ratio of immature to total neutrophils between the baseline and 3-day post-treatment values was higher in the controls than the intervention group. More than 90% of the patients exposed to either rhG-CSF or placebo hospitalized for over 72 hours and no significant difference was found between them (P = 0.946). In each group, a decease was recorded (4.0%) during the hospitalization. Conclusions: The rhG-CSF administration could effectively improve WBC and ANC. No significant changes were observed in mortality rate, adverse effects, and hospital stay after the treatment.

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“…The body weight ranged from 500 to 3,667g, and age was ≤28 days. The median duration of G-CSF treatment was four days (range: 3-14 days) with a dose of 10 mcg/kg/ In relation to the risk of bias, there was no description of the randomization in two studies 17.21 and of the blinded allocation in three 17,21,24 . No blinding of the team was described in one study 17, and there was no double-blinding in another 21 .…”

Section: Resultsmentioning

confidence: 99%

Neonatal sepsis with neutropenia: granulocyte-colony stimulating factor (G-CSF)

Silvinato

Bernardo

Floriano

et al. 2020

Rev. Assoc. Med. Bras.

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The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field in order to standardize producers to assist the reasoning and decision-making of doctors. The information provided through this project must be assessed and criticized by the physician responsible for the conduct that will be adopted, depending on the conditions and the clinical status of each patient. Sepsis is a serious complication in newborns and an important cause of mortality, especially in premature infants. One of the factors that contribute to the susceptibility of these patients to infections is the immaturity of their immune system. One of the possible genesis of this phenomenon seems to lie in the presence of an inhibitor of placental origin, which acts by decreasing the endogenous production of the granulocyte-colony stimulating factor (G-CSF). A systematic review was performed using the PICO search system. Newborns with neonatal sepsis and neutropenia (patient), Treatment with G-CSF plus antibiotics compared with conventional therapy (intervention), Death (any cause), and adverse effects (outcome). The search resulted in 85 articles, of which 12 studies were included. The details of the methodology and results of this guideline are set out in Annex 1.

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A Randomized Case-Controlled Study of Recombinant Human Granulocyte Colony Stimulating Factor for the Treatment of Sepsis in Preterm Neutropenic Infants

Abstract: Treatment with rhG-CSF resulted in a more rapid recovery of ANC in neutropenic preterm infants. However, no reduction in short-term mortality was documented.

Cited by 17 publications

References 24 publications

Neonatal Alloimmune Neutropenia

Neonatal Alloimmune Neutropenia

Clinical and Biochemical Effects of Recombinant Human Granulocyte Colony-Stimulating Factor on the Prognosis of Preterm Infants with Early Onset Neonatal Sepsis

Neonatal sepsis with neutropenia: granulocyte-colony stimulating factor (G-CSF)

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