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Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00009290
Date of registration:	27/10/2015
Prospective Registration:	Yes
Primary sponsor:	Division of Neonatology, Department of Pediatrics, Medical University Graz, Austria
Public title:	Intestinal microbiota composition and diversity in very low and extremely low birthweigt infants related to strategies of NEC prophylaxis - a pilot study
Scientific title:	Intestinal microbiota composition and diversity in very low and extremely low birthweigt infants related to strategies of NEC prophylaxis - a pilot study - Neonatal Microbiomics and NEC prophylaxis
Date of first enrolment:	29/10/2015
Target sample size:	60
Recruitment status:	Complete
URL:	http://drks.de/search/en/trial/DRKS00009290
Study type:	observational
Study design:	Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: basic science
Phase:

Countries of recruitment
Austria

Contacts

Name:	Bernhard Resch
Address:	Auenbruggerplatz 34/2 8036 Graz Austria
Telephone:	004331638581134
Email:	bernhard.resch@medunigraz.at
Affiliation:	Division of Neonatology, Department of Pediatrics, Medical University Graz, Austria

Name:	Bernhard Resch
Address:	Auenbruggerplatz 34/2 8036 Graz Austria
Telephone:	004331638581134
Email:	bernhard.resch@medunigraz.at
Affiliation:	Division of Neonatology, Department of Pediatrics, Medical University Graz, Austria

Key inclusion & exclusion criteria

Inclusion criteria: All infants treated at the Neonatology ward, Department of Pediatrics, Medical University Graz, and at the Neonatology ward, Department of Pediatrics, General hospital of Klagenfurt, or general hospital of Leoben between October 2015 and March 2017, having a birth weight <1500g.
Exclusion criteria: Non viable at birth, death within the first two weeks of life, genetic syndrome disease, malformation, meconium transit disorder.

Age minimum: None
Age maximum: 2 Weeks
Gender: All

Health Condition(s) or Problem(s) studied

Necrotizing Enterocolitis
P77

Necrotizing enterocolitis of fetus and newborn

Intervention(s)

Group 1: Preterm infants <1500g, treated at the Neonatology ward, Department of Pediatrics, Medical University Graz. NEC prophylaxis used at the Neonatology ward, Department of Pediatrics, Medical University Graz, includes Gentamycin 7mg/kg every 12h, Nystatin
10.000U/kg every 6h, Probiosis usingLactobacillus rhamnosus 1g = 1x10^9 CFU/dtwice daily and pooled pasteurized breastmilk 1ml/kg every 3h with an increase of 1ml/kg/d within the first week of life.
Stool samples VLBW preterm infants will be collected every two days within the first weeks of life. 7 samples will be taken of each infant.
Group 2: Preterm infants <1500g, treated at the Neonatology ward, Department of Pediatrics, General Hospital of Klagenfurt am Wörthersee.
There exists no special NEC prophylaxis at the Neonatology ward, Department of Pediatrics, General Hospital of Klagenfurt am Wörthersee. Probiosis using Bifidobacterium infantis 2x10^9 CFU/d and Lactobacillus acidophilus 2x10^9 CFU/d is applied. No standardized application of antibiotics or antimycotics is applied. In case of bacterial infection Ampicillin and Trobramycin are given. Infants <1000g birthweigt receive candidaprohylaxis using Fluconazol 6mg/kg every 72h. Nutrition is based on pasteurized breast milk or formula.
Stool samples VLBW preterm infants will be collected every two days within the first weeks of life. 7 samples will be taken of each infant.
Group 3: Preterm infants <1500g, treated at the Neonatology ward, Department of Pediatrics, General Hospital Leoben.
There exists no special NEC prophylaxis at the Neonatology ward, Department of Pediatrics, General Hospital of Leoben. No probiotics are used. No standardized application of antibiotics or antimycotics is applied. In case of bacteria or fungall infection specific treatment

Primary Outcome(s)

Monitoring changes in composition and diversity of intestinal microbiota in preterm born infants <1500g birth weight within the first weeks of life receiving NEC (necrotizing enterocolitis)-prophylaxis vs not receiving NEC-prophylaxis. Collection of stool samples every 2 days within the first two weeks of life and analysis from microbiota diversity and abundance.

Secondary Outcome(s)

Differences in NEC-incidence between the two groups.

Secondary ID(s)

Source(s) of Monetary Support

Kleine Helden - Initiative für Frühgeborene

Division of Neonatology, Department of Pediatrics, Medical University Graz

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 13/07/2015
Contact:

Ethikkommission Medizinische Universität Graz [Ethikkommission der Medizinischen Universität Graz, Auenbruggerplatz 2, 8036 Graz, Österreich ecs.medunigraz.at]

Results

Results available:
Date Posted:
Date Completed:	20/06/2018
URL:	http://drks.de/search/en/trial/DRKS00009290#studyResults

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