Lactulose Supplementation in Premature Infants

This study has been completed.
Sponsor:
Information provided by:
Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT00616876
First received: February 5, 2008
Last updated: February 14, 2008
Last verified: February 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

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

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.

  Eligibility

Ages Eligible for Study:   23 Weeks to 34 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616876

Locations
Israel
NICU, Department of Neonatology, Bnai Zion Medical Center
Haifa, Israel, 31048
Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
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

Publications:

Responsible Party: Arieh Riskin MD, Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT00616876     History of Changes
Other Study ID Numbers: BZ-23/04, LacPre18
Study First Received: February 5, 2008
Last Updated: February 14, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Bnai Zion Medical Center:
lactulose
prebiotic
premature infant
enteral feeding
stools
lactobacillus
nutrition
growth

Additional relevant MeSH terms:
Enterocolitis
Sepsis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014