Lactulose Supplementation in Premature Infants

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616876
• Other study ID #: BZ-23/04
• Secondary ID: LacPre18
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2008
• Last updated: February 14, 2008
• Start date: February 2005
• Est. completion date: January 2007

Study information

• Verified date: February 2008
• Source: Bnai Zion Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 2007
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 23 Weeks to 34 Weeks

Eligibility

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

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis
• Sepsis

Intervention

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.

Locations

Country	Name	City	State
Israel	NICU, Department of Neonatology, Bnai Zion Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lactulose would support the early growth of Lactobacilli in the stools of premature infants		1.5 years	Yes
Secondary	lactulose would also improve nutritional status and decrease NEC and late-onset sepsis in preterm infants		1.5 years	Yes