Clinical trial NCT00616876: Lactulose Supplementation in Premature Infants
Official title: The Effects of Lactulose Supplementation to Enteral Feedings in Premature Infants - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Necrotizing Enterocolitis
Sepsis
Keywords: lactulose
prebiotic
premature infant
enteral feeding
stools
lactobacillus
nutrition
growth
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-02-15
Enrollment: 28
Sex: ALL
Minimum age (years): 23
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 premature infants and possibly would also improve nutritional status and decrease NEC and late-onset sepsis.

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 placebo in all their feeds (human milk or preterm formula). Clinical parameters will be followed. Stool samples will be sent for culture.

Eligibility criteria: Inclusion Criteria:

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 Criteria:

* Major congenital malformations and parental refusal.

Primary outcomes:
measure: lactulose would support the early growth of Lactobacilli in the stools of premature infants
timeFrame: 1.5 years
Secondary outcomes:
measure: lactulose would also improve nutritional status and decrease NEC and late-onset sepsis in preterm infants
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: NICU, Department of Neonatology, Bnai Zion Medical Center
Study officials:
affiliation: Department of Neonatology, Bnai Zion Medical Center
name: Arieh Riskin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics, Pediatric Gastroenterology, Bnai Zion Medical Center
name: Ron Shaoul, MD
role: PRINCIPAL_INVESTIGATOR
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