CompletedPhase 2/3

Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection

United States2,416 participantsStarted 1988-01

Plain-language summary

A controlled clinical trial was conducted at eight participating centers between January 1, 1988, and March 31, 1991. Patients were randomly assigned to an intravenous immune globulin group or a control group. There were two phases to the study (see below). During phase 1 the control infants received infusions of placebo. During phase 2 the control infants received no infusion therapy.

Who can participate

Age range72 Hours

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All neonates with birth weights of 501 to 1500 g Exclusion Criteria: * More than 72 hours old * One of three or more fetuses from a multiple pregnancy * Had infections associated with toxoplasma, rubella, cytomegalovirus, and herpes simplex viruses (the TORCH complex) * Has a major congenital malformation, an identifiable syndrome, or a chromosomal abnormality * Were considered nonviable * Parental consent could not be obtained

What they're measuring

Incidence of nosocomial infection

Timeframe: 120 days of life

Trial details

NCT IDNCT01203345

SponsorNICHD Neonatal Research Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion1991-03

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