NCT00616876

Lactulose Supplementation in Premature Infants

The Effects of Lactulose Supplementation to Enteral Feedings in Premature Infants - A Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Bnai Zion Medical Center · Other Government
• Sex: All
• Age: 23 Weeks – 34 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Necrotizing Enterocolitis
• Sepsis

Interventions

Type	Name	Description
DRUG	Lactulose	Babies in the study group received lactulose in a dose of 1% in their entire mother's breast milk or preterm formula feeds (1 gram per 100 ml feeds, based on the daily volume of feeds, and evenly distributed between all the feeds for the entire duration of their hospital stay). 67% lactulose in the original preparation (Laevolac, Fresenius Kabi, Austria) was diluted by distilled water to 33.5% preparation in the pharmacy in strict sterile conditions under hood. Just before feeding the nurses added the required volume of this 33.5% lactulose solution to the ordered volume of feed to generate a final concentration of 1% lactulose in each feed.
DIETARY_SUPPLEMENT	Dextrose	Babies in the control groups were given equal volumes of the comparable placebo in all their preterm formula feeds at final concentration of 1% dextrose. The 33.5% dextrose placebo solution was prepared by dissolving dextrose (Dextrose Pulv. USP.24/BP, Roquette Frores 6280, Lestrem, France) in distilled water under heat to the point of near boiling under the same strict sterile conditions in the pharmacy. This gave a placebo solution that looked similar in color, odor and liquidity to the study solution of 33.5% lactulose. Dark bottles were used to further blind the medical team as to what solution was the baby given.

Timeline

• Start date: 2005-02-01
• Primary completion: 2006-08-01
• Completion: 2007-01-01
• First posted: 2008-02-15
• Last updated: 2008-02-15

Locations

1 site across 1 country: Israel