Infant, NewbornPhase 2/3IVIGNCT01203345
Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection
A Phase 2/3 study testing IVIG in people with Infant, Newborn and Infant, Low Birth Weight, run by NICHD Neonatal Research Network at 8 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age
- What is being tested?
- IVIG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,416 participants
- Where
- 8 sitesUnited States
- Study dates
- Jan 1988to Mar 1991
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All neonates with birth weights of 501 to 1500 g
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of Vermont
Burlington, Vermont, 05405
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Wayne State University
Detroit, Michigan, 48201
University of Tennessee
Memphis, Tennessee, 38163
University of Miami
Miami, Florida, 33136
George Washington University
Washington D.C., District of Columbia, 20052
About this study
Official title: Randomized Clinical Trial of Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection in Very-Low-Birth-Weight Infants
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.
Read the detailed description
Although survival rates for very-low-birth-weight infants (≤ 1.5 kg) continue to increase, nosocomial infections remain a major cause of morbidity and mortality. Prolonged hospitalization with exposure to resistant organisms and multiple invasive procedures, in the presence of immunologic immaturity, renders these infants vulnerable to hospital-acquired infections. Prior studies testing the ability of intravenous immune globulin to prevent nosocomial infections in premature infants have varied in design and sample size. Despite differences in the rates of observed infection, immune globulin preparations, doses, and infusion intervals, a meta-analysis of published reports suggests that nosocomial infections may be diminished by the prophylactic infusion of IgG.
The National Institute of Child Health and Human Development (NICHD) Neonatal Research Network therefore performed a prospective, multicenter, randomized trial at eight participating centers to test the hypothesis that the intravenous administration of immune globulin to infants with birth weights between 501 and 1500g would reduce the incidence of nosocomial infections.
Patients were randomly assigned to an intravenous immune globulin group or a control group. During phase 1 the control infants received infusions of placebo. During phase 2 the control infants received no infusion therapy.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Sepsis
- Being tested
- IVIG, Placebo
- Keywords
- NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity, Septicemia, Meningitis, Urinary tract infection, Immune globulin
- Medical subject headings
- Premature Birth, Sepsis, Meningitis, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIGDrug
Also called Sandoglobulin
The infants received their first dose of study drug within 24 hours of randomization.
PlaceboDrug
An equal volume of 5 percent albumin solution
| Study group | Role | What they receive |
|---|---|---|
| Immune globulin | Active comparator | Lyophilized human immune globulin product Receives: Drug: IVIG |
| Albumin solution | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of nosocomial infection
Including septicemia, meningitis, or urinary tract infection
Measured: 120 days of life
Secondary outcomes (5)
Death
Measured: 120 Days of life
Morbidity
Duration of ventilator support, frequency of bronchopulmonary dysplasia, and duration of hospitalization
Measured: 120 days of life
Local infections
Measured: 120 days of life
Necrotizing enterocolitis
Measured: 120 days of life
Specific complications of immune globulin or placebo infusion
Measured: 120 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startJan 1988
- Primary completionMar 1991
- Study completionMar 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,416 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Neonatal Research Network
- Sponsor type
- Research network
- Investigators
- Avroy A. Fanaroff, MD, Study director, Case Western Reserve UniversitySheldon B. Korones, MD, Principal investigator, University of TennesseeElizabeth C. Wright, PhD, Principal investigator, George Washington UniversityRonald L. Poland, MD, Principal investigator, Wayne State UniversityCharles R. Bauer, MD, Principal investigator, University of MiamiJon E. Tyson, MD MPH, Principal investigator, University of TexasJoseph B. Philips, MD, Principal investigator, University of Alabama at BirminghamJerold F. Lucey, MD, Principal investigator, University of Vermont, Burlington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203345
- Sponsor's protocol ID
- NICHD-NRN-0002
- Other IDs
- U10HD021364, U10HD021415, U01HD019897, U10HD021385, U10HD021397, U10HD021373
- Acronym
- IVIG
- Status last verified
- Sep 2010
- First submitted
- 15 Sep 2010
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fanaroff AA, Korones SB, Wright LL, Verter J, Poland RL, Bauer CR, Tyson JE, Philips JB 3rd, Edwards W, Lucey JF, Catz CS, Shankaran S, Oh W. Incidence, presenting features, risk factors and significance of late onset septicemia in very low birth weight infants. The National Institute of Child Health and Human Development Neonatal Research Network. Pediatr Infect Dis J. 1998 Jul;17(7):593-8. doi: 10.1097/00006454-199807000-00004.
PubMed 9686724Fanaroff AA, Korones SB, Wright LL, Wright EC, Poland RL, Bauer CB, Tyson JE, Philips JB 3rd, Edwards W, Lucey JF, et al. A controlled trial of intravenous immune globulin to reduce nosocomial infections in very-low-birth-weight infants. National Institute of Child Health and Human Development Neonatal Research Network. N Engl J Med. 1994 Apr 21;330(16):1107-13. doi: 10.1056/NEJM199404213301602.
PubMed 8133853
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection in Very-Low-Birth-Weight Infants
- ClinicalTrials.gov ID
- NCT01203345
- Acronym / sponsor ID
- IVIG / NICHD-NRN-0002
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Sepsis
- Keywords
- NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity, Septicemia, Meningitis, Urinary tract infection, Immune globulin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,416 participants (actual)
- Lead sponsor
- NICHD Neonatal Research NetworkResearch network
- Study start
- Jan 1988
- Primary completion
- Mar 1991 (actual)
- Study completion
- Mar 1991 (actual)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Although survival rates for very-low-birth-weight infants (≤ 1.5 kg) continue to increase, nosocomial infections remain a major cause of morbidity and mortality. Prolonged hospitalization with exposure to resistant organisms and multiple invasive procedures, in the presence of immunologic immaturity, renders these infants vulnerable to hospital-acquired infections. Prior studies testing the ability of intravenous immune globulin to prevent nosocomial infections in premature infants have varied in design and sample size. Despite differences in the rates of observed infection, immune globulin preparations, doses, and infusion intervals, a meta-analysis of published reports suggests that nosocomial infections may be diminished by the prophylactic infusion of IgG.
The National Institute of Child Health and Human Development (NICHD) Neonatal Research Network therefore performed a prospective, multicenter, randomized trial at eight participating centers to test the hypothesis that the intravenous administration of immune globulin to infants with birth weights between 501 and 1500g would reduce the incidence of nosocomial infections.
Patients were randomly assigned to an intravenous immune globulin group or a control group. During phase 1 the control infants received infusions of placebo. During phase 2 the control infants received no infusion therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immune globulin | Active comparator | Drug: IVIGLyophilized human immune globulin product |
| Albumin solution | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All neonates with birth weights of 501 to 1500 g
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVIGAlso: SandoglobulinThe infants received their first dose of study drug within 24 hours of randomization. | Drug | Immune globulin |
| PlaceboAn equal volume of 5 percent albumin solution | Drug | Albumin solution |
Primary outcome
Incidence of nosocomial infection
Time frame: 120 days of life
Including septicemia, meningitis, or urinary tract infection
5 secondary outcomes
Death
Time frame: 120 Days of life
Morbidity
Time frame: 120 days of life
Local infections
Time frame: 120 days of life
Necrotizing enterocolitis
Time frame: 120 days of life
Specific complications of immune globulin or placebo infusion
Time frame: 120 days of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Results publication: PubMed 9686724Fanaroff AA, Korones SB, Wright LL, Verter J, Poland RL, Bauer CR, Tyson JE, Philips JB 3rd, Edwards W, Lucey JF, Catz CS, Shankaran S, Oh W. Incidence, presenting features, risk factors and significance of late onset septicemia in very low birth weight infants. The National Institute of Child Health and Human Development Neonatal Research Network. Pediatr Infect Dis J. 1998 Jul;17(7):593-8. doi: 10.1097/00006454-199807000-00004.
- Results publication: PubMed 8133853Fanaroff AA, Korones SB, Wright LL, Wright EC, Poland RL, Bauer CB, Tyson JE, Philips JB 3rd, Edwards W, Lucey JF, et al. A controlled trial of intravenous immune globulin to reduce nosocomial infections in very-low-birth-weight infants. National Institute of Child Health and Human Development Neonatal Research Network. N Engl J Med. 1994 Apr 21;330(16):1107-13. doi: 10.1056/NEJM199404213301602.
- NICHD Neonatal Research NetworkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avroy A. Fanaroff, MD study director
Case Western Reserve University
Sheldon B. Korones, MD principal investigator
University of Tennessee
Elizabeth C. Wright, PhD principal investigator
George Washington University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing IVIG in people with Infant, Newborn and Infant, Low Birth Weight, run by NICHD Neonatal Research Network at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of nosocomial infection (time frame: 120 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01203345, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.