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

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.

Conditions

• Mixed Flora; Infection

Sponsors & Collaborators

• University of Tromso

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Ullevaal University Hospital

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• University Hospital of North Norway

  lead OTHER

Principal Investigators

• Claus Klingenberg, MD.phD.Prof. · University Hospital of North Norway

• Eirin Esaiassen, MD · University Hospital of North-Noway

Eligibility

Min Age

1 Hour

Max Age

12 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2015-11-30

Completion

2015-11-30

Countries

• Norway

Study Locations