Dosage of intravenously administered immune globulin and dosing interval required to maintain target levels of immunoglobulin G in low birth weight infants

Kyllonen, Kay; Clapp, D. Wade; Kliegman, Robert M.; Baley, Jill E.; Shenker, Nancy; Fanaroff, Avroy A.; Berger, Melvin

doi:10.1016/s0022-3476(89)80761-9

Cited by 35 publications

(18 citation statements)

References 13 publications

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“…If a study Half-life analysis. We assumed that the time-response curve was approximated by a one-compartment model with resulting simple exponential decay (7,20 A more serious reaction occurred in one infant who manifested generalized urticaria and wheezing 20 min after beginning her first infusion of 500 mg/kg per dose. The symptoms disappeared promptly after the infusion was stopped.…”

mentioning

confidence: 99%

Use of intravenous gamma globulin to passively immunize high-risk children against respiratory syncytial virus: safety and pharmacokinetics. The RSVIG Study Group

Groothuis

Levin

Rodríguez

et al. 1991

Antimicrob Agents Chemother

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Infants with cardiopulmonary disease develop severe illness from respiratory syncytial virus (RSV) infection. Safety, feasibility, and pharmacokinetics of intravenous gamma globulin (IVIG) to prevent RSV illness were studied in 23 high-risk infants in a phase I trial. IVIG with an RSV neutralizing antibody titer of 1:1,100 in 5% solution was given monthly over a 2-to 4-h period in a clinical setting during the RSV season. The first group (n = 7) received 500 mg/kg of body weight, the second group (n = 9) received 600 mg/kg, and the third group (n = 7) received 750 mg/kg. Serum was drawn prior to infusion and 2, 14, and 30 days after infusion. Total immunoglobulin G and RSV A2 and RSV neutralizing antibody levels were obtained after the first IVIG infusion. Two children developed mild reversible pulmonary edema (group receiving 600 mg/kg per dose), and one developed hives and wheezing during one infusion (group receiving 500 mg/kg per dose). Twelve children developed subsequent RSV infection during two RSV seasons (November to April) over a 2-year follow-up period; 9 of 12 developed infection during the infusion year. Eleven illnesses were mild; one child died of progressive RSV illness (group receiving 500 mg/kg per dose). A cumulative infusion effect was not observed. IVIG appears safe and feasible in an outpatient setting, and at 750 mg/kg per dose, a target RSV antibody level of 21:100 was achieved.Respiratory syncytial virus (RSV) is the most common cause of serious respiratory illness in young children (2, 8). Children at greatest risk of serious or fatal RSV lower respiratory tract illness include those with bronchopulmonary dysplasia and congenital heart disease (10-12, 21, 22). Because the level of morbidity is so great in these populations, prevention of serious RSV lower respiratory tract illness is an important goal.It is unlikely that a live vaccine will be available in the near future to prevent high-risk young children from developing serious RSV infection. Vaccine development is proceeding cautiously because of the problem in developing a live vaccine which is safe, stable, and immunogenic and to avoid the serious pulmonary complications seen 20 years ago with the use of a formalin-inactivated vaccine (18

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confidence: 99%

Use of intravenous gamma globulin to passively immunize high-risk children against respiratory syncytial virus: safety and pharmacokinetics. The RSVIG Study Group

Groothuis

Levin

Rodríguez

et al. 1991

Antimicrob Agents Chemother

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“…It is therefore evident that, depending on the pulmonary pathophysiological processes, different anti-infl ammatory agents may have no or only a limited effect on the developing lung injury. On the other hand, the present experimental study documented that IVIG, at a dose shown to reduce the incidence of neonatal infections [14] , increased leukocyte accumulation or, alternatively, their secretory function in the meconium-damaged lung tissue [27] . The mechanisms of this fi nding remain unclear, but polyclonal IgG exposure is shown to prime mononuclear cells for IL-8 production [28] , which could promote intrapulmonary infi ltration of neutrophils.…”

Section: Discussionmentioning

confidence: 53%

“…Eight animals were administered with 800 mg/kg of human polyclonal IgG (Endobulin ® , kindly provided by Immuno AG, Vienna, Austria), infused as a 15% solution (20-30 ml) at a rate of approximately 50 ml/h, 30 min before meconium instillation. The infused IgG dose, containing 99.5% of IgG and at the most 0.2% of IgA, is required to attain a serum level which is associated with a reduced incidence of infections in newborn infants [14] . Eight piglets served as controls and received the same amount of vehicle (saline) only.…”

Section: Experimental Protocolmentioning

confidence: 99%

Intravenous Immunoglobulin G Attenuates Pulmonary Hypertension but Induces Local Neutrophil Influx in Meconium Aspiration in Piglets

Holopainen¹,

Soukka²,

Halkola³

et al. 2005

Neonatology

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Background: Pulmonary hypertension and inflammation are well-identified pathogenetic features in meconium aspiration syndrome of newborns, but current approaches to their treatment or prevention are still often unsatisfactory. Objectives: To investigate the possible protective effects of human intravenous immunoglobulin G (IVIG) on the hypertensive and inflammatory lung injury in severe neonatal meconium aspiration. Methods: Eleven newborn (10–12 days old) ventilated and catheterized piglets that received an intratracheal bolus (3 ml/kg) of a 65-mg/ml mixture of human meconium were studied for 6 h. IVIG was infused in 5 piglets 30 min before meconium administration, and 6 piglets served as controls and received the vehicle only. Results: Meconium instillation induced a biphasic pulmonary hypertensive response, which was significantly diminished by IVIG pretreatment. Similarly, IVIG improved the oxygenation of the piglets, but the intrapulmonary shunt fraction or systemic hemodynamic parameters did not differ between the study groups, except of a minor decrease in the mean arterial blood pressure caused by IVIG. The blood leukocyte count was comparable in the 2 groups. The lung tissue ultrastructural and histological changes, number of apoptotic cells and phospholipase A₂ activity were similar in the 2 groups. The amount of neutrophil accumulation, assessed by myeloperoxidase activity, was however significantly increased in macroscopically damaged lung tissue after IVIG administration. Conclusions: Our results thus indicate that IVIG treatment of newborns with severe meconium aspiration significantly diminishes the pulmonary hypertensive response and improves oxygenation, but the effects do not extend to protection of lung cellular injury.

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“…Several studies of the use of IVIG in neonates were not included in these meta-analyses because the studies were intended for other investigations (eg, pharmacokinetic and safety studies) that did not specifically include prospective evaluation of the effect of IVIG on infection, 18,21,34,45 because the data have appeared only in abstract form with limited information and had not been subject to peer-review, 23,28,31 or because the reports included limited information precluding critical analysis. 16,19,24 Limitations included vague or poor definition of proved sepsis (eg, positive nonquantitative cultures from catheter tips, positive bacterial antigen tests), or the inability to distinguish in the reports the numbers of blood- culture-positive sepsis (ie, proven sepsis) from blood-culture-negative sepsis (ie, suspected or probable sepsis).…”

Section: Resultsmentioning

confidence: 99%

Meta-analyses of the Effectiveness of Intravenous Immune Globulin for Prevention and Treatment of Neonatal Sepsis

Jenson

Pollock

1997

Pediatrics

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ABSTRACT. Objective. To determine the effectiveness of intravenous immune globulin (IVIG) in the prevention and treatment of neonatal sepsis.Design. All published studies of IVIG for the prevention or treatment of neonatal sepsis were reviewed. Peerreviewed, prospective, randomized trials with high merit were analyzed by two meta-analyses. The effect of prophylactic IVIG was evaluated by comparison of the numbers of cases of sepsis (bacteremia in the presence of systemic manifestations of sepsis), and of therapeutic IVIG by comparison of the numbers of deaths resulting from early-onset sepsis.Results. Meta-analysis of 4933 evaluable newborns in 12 studies of IVIG prophylaxis showed a statistically significant negative association with the incidence of sepsis in premature low birth weight newborns given IVIG shortly after birth (P ‫؍‬ .0193, two-sided). The heterogeneity across these studies precluded estimation of a common odds ratio. Meta-analysis of 110 evaluable cases of neonatal sepsis in three studies of IVIG treatment of neonatal sepsis showed a significant decrease in the mortality rate for neonates with sepsis given IVIG (P ‫؍‬ .007, two-sided). The common odds ratio was .173 (95% confidence interval ‫؍‬ .031 to .735).Conclusions. Using conservative and objective outcome rating criteria, the addition of IVIG to standard therapies is of minimal but demonstrable benefit in preventing sepsis when administered prophylactically to premature low birth weight newborns, and of unequivocal benefit in preventing death when administered therapeutically for early-onset neonatal sepsis. The likelihood of newborns with sepsis living past the neonatal period was improved nearly sixfold when IVIG was administered in addition to standard therapies. Pediatrics 1997;99(2). URL: http://www.pediatrics.org/cgi/content/ full/99/2/e2; neonatal sepsis, immune globulin.ABBREVIATIONS. IgG, immunoglobulin G; IVIG, intravenous immune globulin; OR, odds ratio; CI, confidence interval.Humoral immunity of the human newborn is provided primarily by maternal immunoglobulin G (IgG) transferred transplacentally beginning at 8 to 10 weeks of gestation and accelerating during the last trimester. The lack of opsonic antibody is an important risk factor for susceptibility of newborns to infections caused by many bacteria with polysaccharide capsules (eg, group B Streptococcus, Escherichia coli, Haemophilus influenzae type b, Streptococcus pneumoniae) that cause serious bacterial infections in newborns.1,2 Premature infants, compared to full-term infants, have lower levels of IgG at birth that further decreases during the first few weeks of life. The relative deficiency of humoral immunity in premature newborns may contribute to the inverse correlation of birth weight and rate of neonatal sepsis, with an 86-fold increased rate of sepsis in newborns of birth weight 600 to 999 grams compared to newborns of birth weight of more than 2500 grams.

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Dosage of intravenously administered immune globulin and dosing interval required to maintain target levels of immunoglobulin G in low birth weight infants

Cited by 35 publications

References 13 publications

Use of intravenous gamma globulin to passively immunize high-risk children against respiratory syncytial virus: safety and pharmacokinetics. The RSVIG Study Group

Use of intravenous gamma globulin to passively immunize high-risk children against respiratory syncytial virus: safety and pharmacokinetics. The RSVIG Study Group

Intravenous Immunoglobulin G Attenuates Pulmonary Hypertension but Induces Local Neutrophil Influx in Meconium Aspiration in Piglets

Meta-analyses of the Effectiveness of Intravenous Immune Globulin for Prevention and Treatment of Neonatal Sepsis

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