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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02197468
Date of registration:	21/07/2014
Prospective Registration:	Yes
Primary sponsor:	University Hospital of North Norway
Public title:	Preterm Infant Gut (PINGU) - a Norwegian Multi Centre Study PINGU
Scientific title:	Gut Microbiome Study in Preterm Infants - a Norwegian Multi Centre Study
Date of first enrolment:	March 2015
Target sample size:	60
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02197468
Study type:	Observational [Patient Registry]
Study design:
Phase:

Countries of recruitment
Norway

Contacts

Name:	Eirin Esaiassen, MD
Address:
Telephone:
Email:
Affiliation:	University Hospital of North-Noway

Name:	Claus Klingenberg, MD.phD.Prof.
Address:
Telephone:
Email:
Affiliation:	University Hospital of North Norway

Key inclusion & exclusion 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

Age minimum: N/A
Age maximum: 12 Months
Gender: All

Health Condition(s) or Problem(s) studied

Mixed Flora; Infection

Intervention(s)

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Secondary ID(s)

2014/930 (REK)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Tromso

Oslo University Hospital

St. Olavs Hospital

Ullevaal University Hospital

Haukeland University Hospital

Helse Stavanger HF

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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