Intravenous Immunoglobulin Therapy for Prevention of Infection in High-Risk Premature Infants: Report of a Multicenter, Double-Blind Study

PEDIATRICS ◽  
1991 ◽  
Vol 88 (3) ◽  
pp. 437-443
Author(s):  
Jean-François Magny ◽  
Clothilde Bremard-Oury ◽  
Dominique Brault ◽  
Claudie Menguy ◽  
Marcel Voyer ◽  
...  
Keyword(s):  
Placebo Group ◽  
High Risk ◽  
Deleterious Effect ◽  
Controlled Trial ◽  
Immunoglobulin Therapy ◽  
Double Blind Study ◽  
Double Blind ◽  
Intravenous Immunoglobulin Therapy ◽  
Probable Infection ◽  
And Control

The effectiveness of intravenously administered immunoglobulin (Ig) therapy for prophylaxis of infection was evaluated in high-risk preterm infants. Two hundred thirty-five premature newborns were randomly assigned, in a double-blind controlled trial, to treatment and placebo groups. Thirty-five infants (29%) of the Ig group and 29 (25%) of the placebo group had one or more episodes of certain infection. Thirty infants (25%) of the Ig group and 18 (16%) of the placebo group had one or more episodes of probable infection. No significant differences were observed in the incidence of certain or probable infection in treated and control infants. Nevertheless, among the infants who had one or more certain or probable episodes of infection, more of them belonged to the Ig group than to the placebo group. The possible deleterious effect of the administration of large amounts of polyspecific Ig is discussed.

scholarly journals Does progesterone prophylaxis to prevent preterm labour improve outcome? A randomised double-blind placebo-controlled trial (OPPTIMUM)

2018 ◽  
Vol 22 (35) ◽  
pp. 1-304 ◽  
Author(s):  
Jane E Norman ◽  
Neil Marlow ◽  
Claudia-Martina Messow ◽  
Andrew Shennan ◽  
Philip R Bennett ◽  
...  
Keyword(s):  
Placebo Group ◽  
Preterm Birth ◽  
High Risk ◽  
Controlled Trial ◽  
Composite Score ◽  
Singleton Pregnancy ◽  
Double Blind ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Individual Patient Level

Background Progesterone prophylaxis is widely used to prevent preterm birth but is not licensed and there is little information on long-term outcome. Objective To determine the effect of progesterone prophylaxis in women at high risk of preterm birth on obstetric, neonatal and childhood outcomes. Design Double-blind, randomised placebo-controlled trial. Setting Obstetric units in the UK and Europe between February 2009 and April 2013. Participants Women with a singleton pregnancy who are at high risk of preterm birth because of either a positive fibronectin test or a negative fibronectin test, and either previous spontaneous birth at ≤ 34 weeks+0 of gestation or a cervical length of ≤ 25 mm. Interventions Fibronectin test at 18+0 to 23+0 weeks of pregnancy to determine risk of preterm birth. Eligible women were allocated (using a web-based randomisation portal) to 200 mg of progesterone or placebo, taken vaginally daily from 22+0 to 24+0 until 34+0 weeks’ gestation. Participants, caregivers and those assessing the outcomes were blinded to group assignment until data collection was complete. Main outcome measures There were three primary outcomes, as follows: (1) obstetric – fetal death or delivery before 34+0 weeks’ gestation; (2) neonatal – a composite of death, brain injury on ultrasound scan (according to specific criteria in the protocol) and bronchopulmonary dysplasia; and (3) childhood – the Bayley-III cognitive composite score at 22–26 months of age. Results In total, 96 out of 600 (16%) women in the progesterone group and 108 out of 597 (18%) women in the placebo group had the primary obstetric outcome [odds ratio (OR) 0.86, 95% confidence interval (CI) 0.61 to 1.22]. Forty-six out of 589 (8%) babies of women in the progesterone group and 62 out of 587 (11%) babies of women in the placebo group experienced the primary neonatal outcome [OR 0.72, 95% CI 0.44 to 1.17]. The mean Bayley-III cognitive composite score of the children at 2 years of age was 97.3 points [standard deviation (SD) 17.9 points; n = 430] in the progesterone group and 97.7 points (SD 17.5 points; n = 439) in the placebo group (difference in means –0.48, 95% CI –2.77 to 1.81). Limitations Overall compliance with the intervention was 69%. Harms There were no major harms, although there was a trend of more deaths from trial entry to 2 years in the progesterone group (20/600) than in the placebo group (16/598) (OR 1.26, 95% CI 0.65 to 2.42). Conclusions In this study, progesterone had no significant beneficial or harmful effects on the primary obstetric, neonatal or childhood outcomes.The OPPTIMUM trial is now complete. We intend to participate in a comprehensive individual patient-level data meta-analysis examining women with a singleton pregnancy with a variety of risk factors for preterm birth. Trial registration Current Controlled Trials ISRCTN14568373. Funding This trial was funded by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC–NIHR partnership.

Does the Commercial Type of IVIG Used Make a Difference?

PEDIATRICS ◽  
1992 ◽  
Vol 89 (4) ◽  
pp. 806-807
Author(s):  
KHALID H. HAQUE
Keyword(s):  
Premature Infants ◽  
Immunoglobulin Therapy ◽  
Treated Group ◽  
Double Blind Study ◽  
Neonatal Infections ◽  
Double Blind ◽  
Intravenous Immunoglobulin Therapy ◽  
Prevention Of Infection ◽  
Suspected Infection ◽  
Preterm Babies

To the Editor.— I read with interest the article "Intravenous Immunoglobulin Therapy for Prevention of Infection in High-Risk Premature Infants: Report of a Multicenter, Double-Blind Study."1 I would agree with the authors that to date none of the published studies2-10 have shown "absolute and unquestionable efficacy" in the prevention of neonatal infections in all preterm babies, but like others I feel there does seem to be a beneficial trend for the under 1500 g baby.2,3,5,8,10 What worries me about this paper is that contrary to all the previous studies, Magny et al found greater incidence of proven or suspected infection 54% vs 41% in the intravenously administered Ig (IVIG)-treated group.

scholarly journals Effectiveness of Echium amoenum on premenstrual syndrome: a randomized, double-blind, controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Maryam Farahmand ◽  
Davood Khalili ◽  
Fahimeh Ramezani Tehrani ◽  
Gholamreza Amin ◽  
Reza Negarandeh
Keyword(s):  
Placebo Group ◽  
Premenstrual Syndrome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Estimating Equation ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Echium Amoenum ◽  
The Mean ◽  
And Control

Abstract Background The present study aimed to evaluate the effect of Echium amoenum (EA) on the severity of premenstrual syndrome (PMS) in comparison with placebo. Methods The present study was a randomized double-blind controlled clinical trial. A checklist questionnaire was completed by 120, 18 to 35-year-old, college students. And then, 84 eligible women (20 to 35 years old) were enrolled in the trial; they were randomly assigned to two groups of intervention (EA) and control (placebo), with 42 participants in each group. Participants in the intervention group received 450 mg capsules of EA per day (three times a day) from the 21st day of their menstrual cycle until the 3rd day of their next cycle for two consecutive cycles. The severity of PMS was measured and ranked using the premenstrual symptoms screening tool (PSST). The generalized estimating equation was used to compare the total score of the severity of PMS between the two groups. Results Sixty-nine women with regular menstrual cycles suffering from PMS completed the study. The mean scores of the symptoms in the EA group were 35.3 and 16.1 (P ≤ 0.001) at baseline and after 2 months, respectively, while the mean scores of the symptoms in the placebo group were 31.0 and 28.3 (P = 0.09) at baseline and after 2 months, respectively. The evaluation of the first and the second follow-ups in the intervention group showed that, after being adjusted for age and body mass index (P ≤ 0.001), the mean scores of the premenstrual syndrome, using GEE analysis, have decreased to 6.2 and 11.6, respectively. Conclusion Based on the results, in comparison with the placebo group, EA was found to be more effective in improving the symptoms of PMS, and is highly recommended for treatment of this syndrome. Trial registration IRCT2015110822779N3; Registration date: 2015–11–27.

scholarly journals Perioperative Anxiolytic and Analgesic Effects of Pregabalin in Vitreo-Retinal Surgery: A randomized, double-blind study

2021 ◽  
Vol 11 (4) ◽  
Author(s):  
Ayman Elrashidy ◽  
Ahmed Metwally Khattab ◽  
Zeinab Ahmed Elseify ◽  
Mohamed E Oriby
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Needle Insertion ◽  
Anxiety Score ◽  
Control Group ◽  
Double Blind Study ◽  
Double Blind ◽  
Analgesic Effects ◽  
Peribulbar Block ◽  
American Society

Objectives: This study was done to examine the effect of a single, one-time pregabalin dose on postoperative pain, anxiety, and analgesic consumption after vitrectomy performed under the peribulbar block and to assess the satisfaction of the patients as well as the surgeons. Methods: This randomized, double-blinded, placebo-controlled trial was conducted at Magrabi Eye, ENT and Dental Center, Doha, Qatar on 58 adult patients aged 37 - 75 years, who met status I and II of the American Society of Anesthesiologists (ASA) and scheduled for elective vitrectomy, under the peribulbar block (PB). Of the total participants, 30 cases were randomized to receive pregabalin, while the remaining received placebo 90 minutes before surgery. Pain was assessed using a Verbal Analog Scale (VAS) score, and the levels of anxiety were gauged by verbal anxiety score. Results: Patients who received pregabalin had a significantly higher sedation score (3 ± 0 vs. & 2 ± 0.65; P < 0.05), and a significantly less anxiety score (3 ± 1.3 vs. 5 ± 1.6; P < 0.001) compared to the control group. During needle insertion for PB, patients in the pregabalin group experienced less pain compared to the control group (32 ± 15 vs. 44 ± 15; P < 0.05). Pregabalin group showed a significantly higher cooperation rate and patient satisfaction scores (3.2 ± 0.7 and 3.8 ± 0.4, respectively), compared to the placebo group (2.8 ± 0.7 and 3.4 ± 0.5, respectively). The placebo group required intraoperative midazolam more in comparison to the pregabalin group (19 vs. 5; P < 0.001). Moreover, the need for postoperative analgesia was more in the placebo group two hours postoperatively. Conclusions: Pregabalin is a potent premedication in controlling post-surgical pain and anxiety in patients undergoing vitrectomy under the PB.

scholarly journals Randomized, Double-Blind, Placebo-Controlled Trial of Monthly versus Bimonthly Dihydroartemisinin-Piperaquine Chemoprevention in Adults at High Risk of Malaria

2012 ◽  
Vol 56 (3) ◽  
pp. 1571-1577 ◽  
Author(s):  
Khin Maung Lwin ◽  
Aung Pyae Phyo ◽  
Joel Tarning ◽  
Warunee Hanpithakpong ◽  
Elizabeth A. Ashley ◽  
...  
Keyword(s):  
Placebo Group ◽  
High Risk ◽  
Protective Efficacy ◽  
Day Treatment ◽  
Controlled Trial ◽  
Intermittent Preventive Treatment ◽  
Preventive Treatment ◽  
Adult Males ◽  
Double Blind ◽  
Content Type

ABSTRACTIntermittent preventive treatment (IPT) is increasingly used to reduce malaria morbidity and mortality in children and pregnant women. The efficacy of IPT depends on the pharmacokinetic and pharmacodynamic properties of the antimalarial drugs used. Healthy adult male volunteers whose occupation put them at high risk of malaria on the Northwest border of Thailand were randomized to receive a 3-day-treatment dose of dihydroartemisinin-piperaquine monthly (DPm) or every 2 months (DPalt) or an identical placebo with or without fat (6.4g/dose) over a 9-month period. All volunteers were monitored weekly. One thousand adults were recruited. Dihydroartemisinin-piperaquine was well tolerated. There were 114 episodes of malaria (49Plasmodium falciparum, 63P. vivax, and 2P. ovale). The protective efficacy against all malaria at 36 weeks was 98% (95% confidence interval [CI], 96% to 99%) in the DPm group and 86% (95% CI, 81% to 90%) in the DPalt group (for both,P< 0.0001 compared to the placebo group). As a result, the placebo group also had lower hematocrits during the study (P< 0.0001). Trough plasma piperaquine concentrations were the main determinant of efficacy; no malaria occurred in participants with a trough concentration above 31 ng/ml. Neither plasma piperaquine concentration nor efficacy was influenced by the coadministration of fat. DPm is safe to use and is effective in the prevention of malaria in adult males living in an area whereP. vivaxand multidrug-resistantP. falciparummalaria are endemic.

scholarly journals Standardized astragalus extract for attenuation of the immunosuppression induced by strenuous physical exercise: randomized controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Ewa Latour ◽  
Jaroslaw Arlet ◽  
Emilia E. Latour ◽  
Artur Juszkiewicz ◽  
Karolina Łuczkowska ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Interleukin 2 ◽  
Interleukin 4 ◽  
System Response ◽  
Positive Trend ◽  
Double Blind Study ◽  
Cytotoxic Lymphocytes ◽  
Double Blind ◽  
Intensive Training

Abstract Background This paper aimed to verify how a supplementation of rower’s diet with Astragalus Membranaceus Root (AMR) modulated their immune system response to maximal physical exertion. Methods The double-blind study included 18 members of the Polish Rowing Team assigned to the supplemented group (n = 10), and the placebo group (n = 8). The participants performed a 2000 m test on a rowing ergometer at the beginning and at the end of the six-week of intensive training camp during which the supplemented group received 500 mg of AMR. Blood samples were obtained prior to, 1 min after completing, and 24 h after the exertion test. The levels of interleukin 2 (IL2), interleukin 4 (IL4), interleukin 10 (IL10), interferon ɤ (IFN-ɣ), and lactic acid were determined. Subpopulations of T regulatory lymphocytes [CD4+/CD25+/CD127−] (Treg), cytotoxic lymphocytes [CD8+/TCRαβ+] (CTL), natural killer cells [CD3−/CD16+/CD56+] (NK), and TCRδγ-positive cells (Tδγ) were determined with flow cytometry. Results After the camp, the initial NK and Treg levels sustained at the baseline, while Tδγ counts increased relative to the levels in the placebo group. In the supplemented subgroup, a decrease in IL2 level in reaction to maximal exertion clearly deepened while the change in IL-2/IL-10 level induced by the recovery after this exertion clearly increased, relative to the changes in the placebo group. Conclusions AMR restored the immunological balance in strenuously trained athlets through a stabilization of NK and Treg cells with a positive trend in Tδγ towards Th1 response during restitution by cytokine IL2 modulation.

The Effect of Warfarin Sodium on the Duration of Platelet Aggregation

1967 ◽  
Vol 18 (03/04) ◽  
pp. 766-778 ◽  
Author(s):  
H. J Knieriem ◽  
A. B Chandler
Keyword(s):  
Platelet Count ◽  
Placebo Group ◽  
Platelet Aggregation ◽  
Prothrombin Time ◽  
Platelet Rich Plasma ◽  
Healthy Adults ◽  
Double Blind Study ◽  
Double Blind ◽  
Warfarin Sodium

SummaryThe effect of the administration of warfarin sodium (Coumadin®) on the duration of platelet aggregation in vitro was studied. Coumadin was given for 4 consecutive days to 10 healthy adults who were followed over a period of 9 days. The duration of adenosine diphosphate-induced platelet aggregation in platelet-rich plasma, the prothrombin time, and the platelet count of platelet-rich plasma were measured. Four other healthy adults received placebos and participated in a double-blind study with those receiving Coumadin.Although administration of Coumadin caused a prolongation of the prothrombin time to 2 or 21/2 times the normal value, a decrease in the duration of platelet aggregation was not observed. In most individuals who received Coumadin an increase in the duration of platelet aggregation occurred. The effect of Coumadin on platelet aggregation was not consistently related to the prothrombin time or to the platelet count. In the placebo group there was a distinct relation between the duration of platelet aggregation and the platelet count in platelet-rich plasma.The mean increase in the duration of platelet aggregation when compared to the control value before medication with Coumadin was 37.7%. In the placebo group there was a mean increase of 8.4%. The difference between the two groups is significant (p <0.001). Increased duration of platelet aggregation also occurred in two individuals who received Coumadin over a period of 10 and 16 days respectively.

Sign in / Sign up

Export Citation Format

Share Document