International Neonatal Immunotherapy Study
| ISRCTN | ISRCTN94984750 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94984750 |
| Protocol serial number | MRC ref: G9900825; ACTRN12606000273583 |
| Sponsor | University of Oxford (UK) |
| Funders | Medical Research Council (UK), National Health and Medical Research Council (NHMRC) (Australia) |
- Submission date
- 25/10/2000
- Registration date
- 25/10/2000
- Last edited
- 23/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Peter Brocklehurst
Scientific
Scientific
National Perinatal Epidemiology Unit
Institute of Health Sciences
Old Road
Oxford
OX3 7LF
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind placebo-controlled randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | International Neonatal Immunotherapy Study |
| Study acronym | INIS |
| Study objectives | This trial tests the hypothesis that, in infants receiving antibiotics for clinical sepsis, the addition of non-specific, polyclonal intravenous immunoglobulin IgG (IVIG) therapy reduces mortality and major morbidity compared with antibiotics alone. Protocol can be found at: https://www.npeu.ox.ac.uk/downloads/files/inis/INIS-Protocol.pdf |
| Ethics approval(s) | Australia: Westmead Hospital Ethics Committee, 17/12/2001, ref: 2001/7/4.22 (1080) All other centres obtained approval before participating in this trial. |
| Health condition(s) or problem(s) studied | Obstetrics and Gynaecology |
| Intervention | Intravenous infusion of IVIG (500 mg [10 ml]/kg) or matching placebo, repeated after 48 h. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Intravenous immunoglobulin (IVIG) |
| Primary outcome measure(s) |
Mortality or major disability at 2 years of age (corrected for gestational age at birth). |
| Key secondary outcome measure(s) |
1. Short term: mortality, chronic lung disease or major cerebral abnormality before hospital discharge, significant positive culture after trial entry, pneumonia, necrotising enterocolitis, duration of respiratory support |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 5000 |
| Key inclusion criteria | Infants who: 1. Are receiving antibiotics with clinical evidence of definite or highly probable sepsis 2. There is substantial uncertainty that IVIG is indicated 3. Birth weight is less than 1500 g OR already has positive blood or Cerebral Spinal Fluid (CSF) culture OR receiving artificial ventilation |
| Key exclusion criteria | IVIG already given or thought to be needed or contraindicated. |
| Date of first enrolment | 01/06/2001 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
- Argentina
- Australia
- Belgium
- Denmark
- Greece
- Ireland
- New Zealand
- Serbia
Study participating centre
National Perinatal Epidemiology Unit
Oxford
OX3 7LF
United Kingdom
OX3 7LF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 29/09/2011 | Yes | No | |
| Protocol article | protocol | 08/12/2008 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/02/2021: Internal review.
