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Lactulose Supplementation in Premature Infants

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 15, 2008
Last Update Posted: February 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bnai Zion Medical Center
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.

Condition Intervention Phase
Necrotizing Enterocolitis Sepsis Drug: Lactulose Dietary Supplement: Dextrose Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Effects of Lactulose Supplementation to Enteral Feedings in Premature Infants - A Pilot Study

Resource links provided by NLM:

Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • lactulose would support the early growth of Lactobacilli in the stools of premature infants [ Time Frame: 1.5 years ]

Secondary Outcome Measures:
  • lactulose would also improve nutritional status and decrease NEC and late-onset sepsis in preterm infants [ Time Frame: 1.5 years ]

Enrollment: 28
Study Start Date: February 2005
Study Completion Date: January 2007
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Study group will receive 1% lactulose in all their feeds (human milk or preterm formula)
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.
Placebo Comparator: 2
Control group will receive 1% dextrose placebo in all their feeds (human milk or preterm formula).
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.

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.

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Ages Eligible for Study:   23 Weeks to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616876

NICU, Department of Neonatology, Bnai Zion Medical Center
Haifa, Israel, 31048
Sponsors and Collaborators
Bnai Zion Medical Center
Principal Investigator: Arieh Riskin, MD Department of Neonatology, Bnai Zion Medical Center
Principal Investigator: Ron Shaoul, MD Department of Pediatrics, Pediatric Gastroenterology, Bnai Zion Medical Center
  More Information

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Responsible Party: Arieh Riskin MD, Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT00616876     History of Changes
Other Study ID Numbers: BZ-23/04
First Submitted: February 5, 2008
First Posted: February 15, 2008
Last Update Posted: February 15, 2008
Last Verified: February 2008

Keywords provided by Bnai Zion Medical Center:
premature infant
enteral feeding

Additional relevant MeSH terms:
Premature Birth
Enterocolitis, Necrotizing
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Agents

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