Status:
COMPLETED
Lactulose Supplementation in Premature Infants
Lead Sponsor:
Bnai Zion Medical Center
Conditions:
Necrotizing Enterocolitis
Sepsis
Eligibility:
All Genders
23-34 years
Phase:
PHASE2
Brief Summary
A pilot study to test the safety of use of lactulose in preterm infants and to preliminary assess the hypothesis that lactulose would support the early growth of Lactobacilli in the stools of prematur...
Detailed Description
Prospective, double-blind, placebo-controlled single center pilot study in 23-34 weeks gestation premature infants. Study group will receive 1% lactulose, while control group will receive 1% dextrose ...
Eligibility Criteria
Inclusion
- Premature infants were recruited based on the following criteria:
- 23-34 weeks' gestation (as determined by a combination of maternal dates, early prenatal ultrasonography and postnatal gestational age estimation based on physical and neuromuscular signs (New Ballard Score), as long as there will be gestational age agreement between the 3 methods \< 2 weeks);
- Absence of major congenital malformations; and
- Informed consent obtained from parents.
Exclusion
- Major congenital malformations and parental refusal.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00616876
Start Date
February 1 2005
End Date
January 1 2007
Last Update
February 15 2008
Active Locations (1)
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1
NICU, Department of Neonatology, Bnai Zion Medical Center
Haifa, Israel, 31048