Probiotics to Prevent NEC - a Historical Control Study

Study Overview
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Brief Summary
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Probiotics is given routinely to infants admitted to the department of neonatology during the first 3 days of life with gestational age less than 30 weeks since March 2010. The incidence of necrotizing enterocolitis Bell stage II and III will be assessed blindly from clinical records. It is hypothesised that the incidence of NEC will decrease. Infants admitted from 1 March 2010 to 28 February 2013 will be compared to infants admitted 1 Dec 2007 to 30 Nov 2009 will be compared.

Official Title
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Probiotics to Prevent NEC Stage II+ in Very Preterm Infants - a Historical Control Study

Conditions
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Necrotizing Enterocolitis

Intervention / Treatment
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* Dietary Supplement: probiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age less than 30 weeks Admission during the first 3 days of life

Ages Eligible for Study
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Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Probiotics<br>Capsule with 1 x 10**9 Lactobacillus rhamnosus GG and 1 x 10**8 Bifidobacterium BB12. Two capsules once a day. The capsules are opened and the content is dissolved in mother's milk or water if the baby is given any milk. In tube fed infants, two drops are given in the mouth and the rest in the nasogastric tube. | Dietary Supplement: probiotics<br>* Capsule with 1 x 10**9 Lactobacillus rhamnosus GG and 1 x 10**8 Bifidobacterium BB12. Two capsules once a day. The capsules are opened and the content is dissolved in mother's milk or water if the baby is given any milk. In tube fed infants, two drops are given in the mouth and the rest in the nasogastric tube.<br>* Other names: Idoform, Ferronan A/S;|
| Control<br>Probiotics never given | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NEC | The clinical records of infants who had a discharge diagnosis of necrotizing enterocolitis are selected. Records of infants who had a prescription of metronidazole for a non-preventive purpose is added. The clinical records are abstracted. The abstracts and X-rays are presented to a review board that are blinded to the period of birth. The board classifies the cases as NEC-I, NEC-II, NEC-III, focal intestinal perforation, and OTHER. NEC-II/III is the primary outcome. | From birth until discharge home | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death with NEC | Death with a review board classification of NEC-II/III | Birth to discharge home | 
| Death |  | Birth to discharge home | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Necrotizing enterocolitis, Probiotics, Preterm, Infant