Dettagli per singolo studio

DEC-NET Serial number GB407

Published online	24/05/2005 12.27.00
Last updated	06/03/2006 14.58.55

Other protocol ID number	G9900825
This trial has been approved by an ethics committee
Current trial status	Open (actively recruiting new participants)
First subject enrolment Target N. of subjects	06/2001 5000
Major Disease (ICD9 class)	Other infection specific to the perinatal period. Incl. Septicemia [sepsis] of newborn
Experimental drug
Non-specific, polyclonal intravenous immunoglobulin IgG (IVIG) Treatment regimen (dosage and duration) 500mg [10ml] / kg over 4-6 hours, repeated 48 hours later in experimental group. The control group will receive a corresponding amount of normal saline
Gender	Both
Age (range)	0 -27 days
Eligibility criteria
Inclusion criteria
Infants are eligible if; they are receiving antibiotics with clinical evidence of definite or high probable sepsis, there is substantial uncertainty that IVIG is indicated, and they have at least one of the following - birth weight <1.5kg OR already has positive blood or serebral spinal fluid culture OR receiving artificial ventilation. Hospitals will be eligible for entry if they can provide neonatal intemsive or soecial care, can achieve satisfactory rates of follow up at two years and would be able to institute the routine use of adjuvant IVIG for babies with sepsis if the trial demonstrates evidence of benefit.
Exclusion criteria
IVIG already given IVIG thought to be needed or contra indicated
Trial design/methodology
Phase	3
Kind of study	Efficacy
Design	Controlled Randomised Blinded Double blind
Purpose of study
To test the hypothesis that, in infants receiving antibiotics for clinical sepsis, the addition of non-specific, polyclonal intravenous immunoglobin IgG (IVIG) therapy reduces mortality and major morbidity compared with antibiotics alone.
Primary outcomes
Mortality or major disability at two years of age (corrected for gestational age at birth).
Secondary outcomes
a) at two years of age - mortality, major disability, non-major disability b) at hospital discharge - chronic lung disease, major cerebral abnormality, length of hospital stay.
Summary of study design, objectives, and ongoing research findings
INIS is a multi-centre, pragmatic double-blind placebo controlled randomised trial comparing the effect of intravenous immunoglobulin with placebo in the current management of neonatal sepsis. 5000 patients will be recruited, 2500 will receive 500mg10mil of non-specific, polyclonal intravenous immunoglobulin IgG (IVIG) over 4-6 hours, repeated 48 hours later; whilst the controls will receive the same treatment regime using a long chain polysaccharide solution of normal saline instead. The study's objective is to evaluate whether the administration of intravenous immunoglobulin in addition to antibiotics for suspected neonatal sepsis, has beneficial effects on mortality or major disability at 2 years of age corrected for gestational age at birth.