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Neurodevelopmental Outcomes After Suspected or Proven Sepsis: Secondary Analysis of INIS Trial Database

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ClinicalTrials.gov Identifier: NCT02281890
Recruitment Status : Completed
First Posted : November 4, 2014
Last Update Posted : November 4, 2014
Sponsor:
Collaborators:
INIS Collaborative Group
Maastricht University Medical Center
Erasmus Medical Center
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:
Neonatal sepsis is an important determinant of adverse neurodevelopmental outcome. The investigators seek to investigate whether neurodevelopmental outcome following neonatal sepsis differs according to whether or not the diagnosis is confirmed by culture. In a secondary analysis of all 3493 infants included in the International Neonatal Immunotherapy Study (INIS) randomized controlled trial of intravenous immunoglobulin for neonatal sepsis, the investigators will evaluate neurodevelopmental outcomes according to whether or not the sepsis was culture-proven. The primary outcome is death or major disability at two years. In secondary analyses the investigators will determine neurodevelopmental outcomes according to the causative organism identified. Greater understanding of the impact of culture-positivity on long-term outcomes in the setting of clinical neonatal sepsis is essential to better inform parents about the future prospects of their child and to guide patient follow-up.

Condition or disease Intervention/treatment
Neonatal Sepsis Other: Proven sepsis

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Study Type : Observational
Actual Enrollment : 3493 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurodevelopmental Outcomes After Suspected or Proven Sepsis: Secondary Analysis of INIS Trial Database
Study Start Date : October 2001
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort Intervention/treatment
Proven sepsis
Children included in the INIS trial in whom pathogenic organisms (i.e. bacteria or fungi) were cultured from blood and/or cerebrospinal fluid during the sepsis period at the time of study inclusion
Other: Proven sepsis
Exposure is proven sepsis

Clinical sepsis
Children included in the INIS trial in whom no pathogenic organisms (i.e. bacteria or fungi) were cultured from blood or cerebrospinal fluid during the sepsis period at the time of study inclusion



Primary Outcome Measures :
  1. death or major disability [ Time Frame: 2 years ]
    Death or major disability at two years of age. The diagnosis of major disability was based on the answers to questions on the HSQ or the PQ [see Study Description and INIS Collaborative Group 2011 (online supplement) for more detail]. If the domain classification was unknown and a SHSQ had been received, the classification from that questionnaire was used for that domain only.


Secondary Outcome Measures :
  1. death [ Time Frame: two years ]
    death before two years of age

  2. disability [ Time Frame: two years ]
    Disability at two years of age, categorised as major or non-major. The diagnosis of disability was based on the answers to questions on the HSQ or the PQ [see Study Description and INIS Collaborative Group 2011 (online supplement) for more detail]. If the domain classification was unknown and a SHSQ had been received, the classification from that questionnaire was used for that domain only.

  3. disability due to seizures [ Time Frame: two years ]
    Disability due to seizures at two years of age, categorised as major or non-major. The diagnosis of disability due to seizures was based on the answers to questions on the HSQ or the PQ [see Study Description and INIS Collaborative Group 2011 (online supplement) for more detail]. If the domain classification was unknown and a SHSQ had been received, the classification from that questionnaire was used.

  4. hearing disability [ Time Frame: two years ]
    Hearing disability at two years of age, categorised as major or non-major. The diagnosis of hearing disability was based on the answers to questions on the HSQ or the PQ [see Study Description and INIS Collaborative Group 2011 (online supplement) for more detail]. If the domain classification was unknown and a SHSQ had been received, the classification from that questionnaire was used.

  5. visual disability [ Time Frame: two years ]
    Visual disability at two years of age, categorised as major or non-major. The diagnosis of visual disability was based on the answers to questions on the HSQ or the PQ [see Study Description and INIS Collaborative Group 2011 (online supplement) for more detail]. If the domain classification was unknown and a SHSQ had been received, the classification from that questionnaire was used.

  6. communicative disability [ Time Frame: two years ]
    Communicative disability at two years of age, categorised as major or non-major. The diagnosis of communicative disability was based on the answers to questions on the HSQ or the PQ [see Study Description and INIS Collaborative Group 2011 (online supplement) for more detail]. If the domain classification was unknown and a SHSQ had been received, the classification from that questionnaire was used.

  7. cognitive disability [ Time Frame: two years ]
    Cognitive disability at two years of age, categorised as major or non-major. The diagnosis of cognitive disability was based on PARCA-R1 [Saudino 1998], as described previously [INIS Collaborative Group 2011 (online supplement)]

  8. neuromotor disability [ Time Frame: two years ]
    Neuromotor disability at two years of age, categorised as major or non-major. The diagnosis of neuromotor disability was based on the answers to questions on the HSQ or the PQ [see Study Description and INIS Collaborative Group 2011 (online supplement) for more detail]. If the domain classification was unknown and a SHSQ had been received, the classification from that questionnaire was used.



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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of all babies included in the INIS trial. The INIS trial was an RCT of intravenous immunoglobulin (two infusions of 500 mg/kg body weight polyvalent IgG) versus placebo in the treatment of suspected or proven neonatal sepsis.[5] 3493 infants were included from 113 hospitals in nine countries.[6]
Criteria

Inclusion Criteria:

  • Children included in the INIS trial

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281890


Sponsors and Collaborators
University of Edinburgh
INIS Collaborative Group
Maastricht University Medical Center
Erasmus Medical Center
Investigators
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Principal Investigator: Ben Stenson, MD University of Edinburgh
Principal Investigator: Peter Brocklehurst, MD University of Oxford
Publications:
Saudino KJ, Dale PS, Oliver B, Petrill SA, Richardson V, Rutter M, Simonoff E, Stevenson J, Plomin R. The validity of parent-based assessment of the cognitive abilities of two-year olds. British Journal of Developmental Psychology 16: 349-363, 1998.

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02281890    
Other Study ID Numbers: INIS-01
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: October 2014
Keywords provided by University of Edinburgh:
neurodevelopmental disability
Additional relevant MeSH terms:
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Sepsis
Toxemia
Neonatal Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases