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

NCT02281890 | Completed

• 1 other identifier: INIS-01
• Study Type: observational
• Target: 3,493
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neonatal Sepsis

Keywords

neurodevelopmental disability

Outcome Measures

Primary Outcomes (1)

• death or major disability

  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.

  2 years

Secondary Outcomes (8)

• death

  two years

• disability

  two years

• disability due to seizures

  two years

• hearing disability

  two years

• visual disability

  two years

Study Arms (2)

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

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

Interventions

Proven sepsis OTHER

Exposure is proven sepsis

Proven sepsis

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.\[6\]

You may qualify if:

• Children included in the INIS trial

You may not qualify if:

• None

Sponsors & Collaborators

• University of Edinburgh: lead
• INIS Collaborative Group: collaborator
• Maastricht University Medical Center: collaborator
• Erasmus Medical Center: collaborator

Related Publications (7)

• Adams-Chapman I, Stoll BJ. Neonatal infection and long-term neurodevelopmental outcome in the preterm infant. Curr Opin Infect Dis. 2006 Jun;19(3):290-7. doi: 10.1097/01.qco.0000224825.57976.87.

  PMID: 16645492 BACKGROUND

• Stoll BJ, Hansen NI, Adams-Chapman I, Fanaroff AA, Hintz SR, Vohr B, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental and growth impairment among extremely low-birth-weight infants with neonatal infection. JAMA. 2004 Nov 17;292(19):2357-65. doi: 10.1001/jama.292.19.2357.

  PMID: 15547163 BACKGROUND

• Alshaikh B, Yusuf K, Sauve R. Neurodevelopmental outcomes of very low birth weight infants with neonatal sepsis: systematic review and meta-analysis. J Perinatol. 2013 Jul;33(7):558-64. doi: 10.1038/jp.2012.167. Epub 2013 Jan 17.

  PMID: 23328927 BACKGROUND

• Schlapbach LJ, Aebischer M, Adams M, Natalucci G, Bonhoeffer J, Latzin P, Nelle M, Bucher HU, Latal B; Swiss Neonatal Network and Follow-Up Group. Impact of sepsis on neurodevelopmental outcome in a Swiss National Cohort of extremely premature infants. Pediatrics. 2011 Aug;128(2):e348-57. doi: 10.1542/peds.2010-3338. Epub 2011 Jul 18.

  PMID: 21768312 BACKGROUND

• INIS Study Collaborative Group. The INIS Study. International Neonatal Immunotherapy Study: non-specific intravenous immunoglobulin therapy for suspected or proven neonatal sepsis: an international, placebo controlled, multicentre randomised trial. BMC Pregnancy Childbirth. 2008 Dec 8;8:52. doi: 10.1186/1471-2393-8-52.

  PMID: 19063731 BACKGROUND

• INIS Collaborative Group; Brocklehurst P, Farrell B, King A, Juszczak E, Darlow B, Haque K, Salt A, Stenson B, Tarnow-Mordi W. Treatment of neonatal sepsis with intravenous immune globulin. N Engl J Med. 2011 Sep 29;365(13):1201-11. doi: 10.1056/NEJMoa1100441.

  PMID: 21962214 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ben Stenson, MD

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

• Peter Brocklehurst, MD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: November 4, 2014
• Study Start: October 1, 2001
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: November 4, 2014

Record last verified: 2014-10