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Preterm Infant Gut (PINGU) - a Norwegian Multi Centre Study (PINGU)

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ClinicalTrials.gov Identifier: NCT02197468
Recruitment Status : Completed
First Posted : July 22, 2014
Last Update Posted : March 11, 2019
Sponsor:
Collaborators:
University of Tromso
Oslo University Hospital
Ullevaal University Hospital
St. Olavs Hospital
Haukeland University Hospital
Helse Stavanger HF
Information provided by (Responsible Party):
University Hospital of North Norway

Tracking Information
First Submitted Date July 21, 2014
First Posted Date July 22, 2014
Last Update Posted Date March 11, 2019
Study Start Date March 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 19, 2014)
To assess gut microbiome composition (meta genome sequencing) of preterm infants receiving probiotics versus preterm infants not receiving probiotics [ Time Frame: 4 time points: 7 days of age, 4 weeks of age, 4 months corrected age and 12 months corrected age ]
Stools samples from preterm infants and term infants (control)
Original Primary Outcome Measures
 (submitted: July 21, 2014)
  • Gut microbiome composition [ Time Frame: 7 days of age ]
    Stools samples from preterm infants and term infants
  • Gut microbiome composition [ Time Frame: 4 weeks of age ]
    Stool samples from preterm and term infants
  • Gut microbiome composition [ Time Frame: 4 months corrected age ]
    Stool samples from preterm and term infants
  • Gut microbiome composition [ Time Frame: 12 months corrected age ]
    Stool samples from preterm and term infants
Change History
Current Secondary Outcome Measures
 (submitted: August 19, 2014)
Impact of antibiotic exposure on gut microbiome [ Time Frame: 4 time points: 7 days of age, 4 weeks of age, 4 months corrected age and 12 months corrected age ]
Stool samples from preterm and term infants
Original Secondary Outcome Measures
 (submitted: July 21, 2014)
Impact of antibiotics on gut microbiome [ Time Frame: 7 days of age, 4 weeks of age, 4 months corrected age and 12 months corrected age ]
Stool samples from preterm and term infants
Current Other Pre-specified Outcome Measures
 (submitted: July 21, 2014)
Cross contamination of probiotic bacteria in a NICU [ Time Frame: 7 days of age and 4 weeks of age ]
Detection of probiotic bacterial microbiome profiles in children not receiving probiotics
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Preterm Infant Gut (PINGU) - a Norwegian Multi Centre Study
Official Title Gut Microbiome Study in Preterm Infants - a Norwegian Multi Centre Study
Brief Summary

Necrotizing enterocolitis (NEC) is a leading cause of morbidity and mortality among infants in the neonatal intensive care unit (NICU). It has been postulated that abnormal colonization of the preterm gut, or an unfavorable balance between gut bacteria may contribute to the development of NEC.

Recent clinical randomized studies and meta-analysis have shown that proactive colonization of probiotic bacteria reduce the frequency of NEC. Based on this evidence, in April 2014 all Norwegian NICUs started routinely administration of probiotics to all extremely premature neonates susceptible to NEC (gestational age <28 weeks/birth weight <1000g).

The current project is investigating the gut microbiome in patients receiving probiotics and compare the the gut microbiome with moderate premature infants not receiving probiotics. In addition, we are including a control of healthy full-term infants.

Samples containing feces from participants will be analyzed by state of the art whole-genome sequencing techniques. Bacterial diversity will be analysed with bioinformatic tools.

Study hypotheses:

  • Probiotics given to extremely preterm infants will change the biodiversity of the gut microflora.
  • Antibiotics given to these patients may influence the gut microflora also in infants receiving probiotics. In particular use of vancomycin may change the gut flora.
  • After cessation of probiotic prophylaxis the gut flora of infants receiving probiotics will gradually resemble the gut flora of infants not receiving probiotics.
  • A cross-contamination of probiotic bacteria between patients treated with probiotics and patients not treated with antibiotics may occur.
Detailed Description

Necrotizing enterocolitis (NEC) is a leading cause of morbidity and mortality among infants in the neonatal intensive care unit (NICU). Prematurity is the most important risk factor for NEC. The pathogenesis of NEC remains unclear, and prevention and treatment strategies are limited. It has been postulated that abnormal colonization of the preterm gut, or an unfavorable balance between gut bacteria, is significant in the pathogenesis of NEC.

Recent clinical randomized studies and meta-analysis have shown that proactive colonization of probiotic bacteria reduce the frequency of NEC. Based on this evidence, in April 2014 all Norwegian NICUs started routinely administration of probiotics to all extremely premature neonates susceptible to NEC (gestational age (GA) <28 weeks/birth birth weight (BW) <1000 g).

The current project is investigating the gut microbiome in patients receiving probiotics and compare the the gut microbiome with moderate premature infants not receiving probiotics. In addition, we are including a control of healthy full-term infants.

Samples containing feces from participants will be analyzed by state of the art whole-genome sequencing techniques. Bacterial diversity and taxonomy will be analysed using bioinformatic tools

Inclusion criteria:

  • Preterm infants 24-27 weeks gestation/ birth weight < 1000 g receiving probiotics
  • Preterm infants 28-31 weeks gestation/BW 1000-1500 g not receiving probiotics
  • Healthy term infants

Exclusion criteria

  • Preterm infants < 24 weeks gestation
  • Preterm infants < 32 weeks with severe lethal complication/poor prognosis around 1 week of age
  • Infants with severe congenital malformations

Fecal samples will be obtained:

  • 1 week of age
  • 4 weeks of age
  • 4 months corrected age
  • 12 months corrected age

Study hypotheses:

  • Probiotics given to extremely preterm infants will change the biodiversity of the gut microflora.
  • Antibiotics given to these patients may influence the gut microflora also in infants receiving probiotics. In particular use of vancomycin may change the gut flora.
  • After cessation of probiotic prophylaxis the gut flora of infants receiving probiotics will gradually resemble the gut flora of infants not receiving probiotics.
  • A cross-contamination of probiotic bacteria between patients treated with probiotics and patients not treated with antibiotics may occur.

This is an explorative study. No formal sample size assessment is possible. Sequencing costs will be substantial. We will limit the number of participants to 26 x 2 preterm infants and 10 control healthy infants.

Six Norwegian Neonatal Intensive care units wil participate in the study.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Retention:   Samples With DNA
Description:
Fecal samples for bacterial DNA analyses
Sampling Method Non-Probability Sample
Study Population Preterm infants hospitalized in 6 Norwegian NICUs; divided in one group extremely preterm infants receiving probiotics and one group moderate preterm infants not receiving antibiotics. A group of helathy infants from the post-natal ward will also be included
Condition Mixed Flora; Infection
Intervention Not Provided
Study Groups/Cohorts Probiotics

Preterm infants given probiotics: GA 24-27 weeks/Birth weight < 1000 g

Preterm infants not given probiotics: GA 28-31 weeks/Birth weight 1000-1500 g

Full-term infants not given probiotics (control)

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 21, 2014)
60
Original Estimated Enrollment Same as current
Actual Study Completion Date November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Preterm infants with gestational age 24-27 weeks/birth weight < 1000 g, treated with probiotics (target number 26)
  • Preterm infants with gestational age 29-31 weeks/birth weight 1000-1500 g, not treated with probiotics (target number 26)
  • Term infants (target number 10)

Exclusion Criteria:

  • Extremely preterm infants with gestational age below 24 weeks
  • Preterm infants (24-31 weeks) with life threatening complications during 1 week of age
  • Infants with congenital malformations
Sex/Gender
Sexes Eligible for Study: All
Ages up to 12 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT02197468
Other Study ID Numbers 2014/930 (REK)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital of North Norway
Study Sponsor University Hospital of North Norway
Collaborators
  • University of Tromso
  • Oslo University Hospital
  • Ullevaal University Hospital
  • St. Olavs Hospital
  • Haukeland University Hospital
  • Helse Stavanger HF
Investigators
Study Chair: Claus Klingenberg, MD.phD.Prof. University Hospital of North Norway
Principal Investigator: Eirin Esaiassen, MD University Hospital of North-Noway
PRS Account University Hospital of North Norway
Verification Date June 2016