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

February 5, 2008
February 14, 2008
February 2005
August 2006   (final data collection date for primary outcome measure)
lactulose would support the early growth of Lactobacilli in the stools of premature infants [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00616876 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Lactulose Supplementation in Premature Infants
The Effects of Lactulose Supplementation to Enteral Feedings in Premature Infants - A Pilot Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Necrotizing Enterocolitis
  • Sepsis
  • 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.
  • Experimental: 1
    Study group will receive 1% lactulose in all their feeds (human milk or preterm formula)
    Intervention: Drug: Lactulose
  • Placebo Comparator: 2
    Control group will receive 1% dextrose placebo in all their feeds (human milk or preterm formula).
    Intervention: Dietary Supplement: Dextrose

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
January 2007
August 2006   (final data collection date for primary outcome measure)

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.
Both
23 Weeks to 34 Weeks
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00616876
BZ-23/04, LacPre18
No
Arieh Riskin MD, Bnai Zion Medical Center
Bnai Zion Medical Center
Not Provided
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
Bnai Zion Medical Center
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP