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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00977912
Other study ID # 08.09.INF
Secondary ID
Status Terminated
Phase N/A
First received September 15, 2009
Last updated November 22, 2013
Start date November 2009
Est. completion date September 2013

Study information

Verified date November 2013
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority South Africa: Human Research Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.


Recruitment information / eligibility

Status Terminated
Enrollment 318
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 48 Hours
Eligibility Inclusion Criteria:

- Weight between 800 - 1500g

- Tolerating enteral feeding within 48 hours

- Having obtained his/her parents or legal representative informed consent

Exclusion Criteria:

- Chromosomal abnormality

- Hydrops featalis

- Congenital malformation of the gastrointestinal tract

- Congenital heart defects or other major congenital abnormalities likely to affect feeding and/or feeding tolerance

- Currently participating in another clinical trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Dietary Supplement:
Probiotic supplementation
one capsule containing probiotics per day added to milk
Milk containing placebo
one capsule containing placebo per day added to milk

Locations

Country Name City State
South Africa University of Witwatersrand & Chris Hani Baragwanath Hospital Bertsham
South Africa University of Witwatersrand & Rahima Moosa Mother & Child Hospital Johannesburg
South Africa University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital Johannesburg

Sponsors (1)

Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary NEC onset 6 weeks No
Secondary Antibiotic administration and stool microbiology 6 weeks No
See also
  Status Clinical Trial Phase
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Recruiting NCT03210831 - Early Predictors of Necrotizing Enterocolitis in Neonates
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Recruiting NCT02552706 - The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis N/A
Completed NCT02400697 - Placental Transfusion Project for Preterm Infants N/A
Completed NCT01751477 - Infloran® for Prevention of Necrotizing Enterocolitis N/A
Terminated NCT01156480 - Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants N/A
Completed NCT00787124 - Transfusions and Nitric Oxide Level in Preterm Infants
Unknown status NCT00254176 - Cysteine Supplementation in Critically Ill Neonates Phase 2/Phase 3
Recruiting NCT01441739 - Intestinal Failure in Necrotising Enterocolitis N/A
Recruiting NCT03869827 - Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction
Recruiting NCT04074824 - A Genome-Wide Association Study for Neonatal Diseases
Terminated NCT03320785 - Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
Active, not recruiting NCT03554278 - Alteration of Stool Microbiota in Preterm Infants With Anemia
Not yet recruiting NCT04541771 - The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants Phase 2
Not yet recruiting NCT03700957 - The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates N/A
Completed NCT03551600 - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Completed NCT01745510 - Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates Phase 1/Phase 2
Completed NCT01735578 - Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis N/A
Unknown status NCT01807858 - The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants N/A