Preterm Infant Gut (PINGU) - a Norwegian Multi Centre Study (PINGU)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02197468 |
Recruitment Status :
Completed
First Posted : July 22, 2014
Last Update Posted : March 11, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease |
---|
Mixed Flora; Infection |
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] |
Actual Enrollment : | 60 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 1 Year |
Official Title: | Gut Microbiome Study in Preterm Infants - a Norwegian Multi Centre Study |
Study Start Date : | March 2015 |
Actual Primary Completion Date : | November 2015 |
Actual Study Completion Date : | November 2015 |

Group/Cohort |
---|
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) |
- 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)
- 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
- 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
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 12 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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): NCT02197468
Norway | |
Haukeland Universtiy Hospital | |
Bergen, Norway, 5021 | |
Oslo University Hospital, Rikshospitalet | |
Oslo, Norway, 0424 | |
Oslo University Hospital, Ullevaal | |
Oslo, Norway, 0424 | |
Ahus University Hospital | |
Oslo, Norway | |
Stavanger University Hospital | |
Stavanger, Norway, 4011 | |
University Hospital of North Norway | |
Tromsø, Norway, 9038 | |
St Olavs Hospital, Trondheim University Hospital | |
Trondheim, Norway, 7030 |
Study Chair: | Claus Klingenberg, MD.phD.Prof. | University Hospital of North Norway | |
Principal Investigator: | Eirin Esaiassen, MD | University Hospital of North-Noway |
Study Data/Documents: Clinical Study Report

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University Hospital of North Norway |
ClinicalTrials.gov Identifier: | NCT02197468 |
Other Study ID Numbers: |
2014/930 (REK) |
First Posted: | July 22, 2014 Key Record Dates |
Last Update Posted: | March 11, 2019 |
Last Verified: | June 2016 |
Gut microbiome Necrotizing enterocolitis Antibiotics |