Lactulose Supplementation in Premature Infants

Phase 2

Completed

• Conditions: Necrotizing Enterocolitis; Sepsis
• Interventions: Dietary Supplement: Dextrose; Drug: Lactulose

• Registration Number: NCT00616876
• Lead Sponsor: Bnai Zion Medical Center

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.

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2006-08
• Study Completion: 2007-01
• Status Verified: 2008-02
• Study First Submitted: 2008-02-05
• Study First Submitted QC: 2008-02-14
• Last Update Submitted: 2008-02-14
• Study First Posted: 2008-02-15
• Last Update Posted: 2008-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Dextrose	Control group will receive 1% dextrose placebo in all their feeds (human milk or preterm formula).
1	Lactulose	Study group will receive 1% lactulose in all their feeds (human milk or preterm formula)

Primary Outcome Measures

Name	Time	Method
lactulose would support the early growth of Lactobacilli in the stools of premature infants	1.5 years

Secondary Outcome Measures

Name	Time	Method
lactulose would also improve nutritional status and decrease NEC and late-onset sepsis in preterm infants	1.5 years

Trial Locations

Locations (1)

NICU, Department of Neonatology, Bnai Zion Medical Center; 🇮🇱 Haifa, Israel