Lactulose Supplementation in Premature Infants - Full Text View

Sponsored by:	Bnai Zion Medical Center
Information provided by:	Bnai Zion Medical Center
ClinicalTrials.gov Identifier:	NCT00616876

Sponsored by:

Bnai Zion Medical Center

Information provided by:

Bnai Zion Medical Center

ClinicalTrials.gov Identifier:

NCT00616876

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 II

MedlinePlus related topics: Dietary Supplements Premature Babies Sepsis

Drug Information available for: Dextrose Lactulose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Effects of Lactulose Supplementation to Enteral Feedings in Premature Infants - A Pilot Study

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
1: Experimental 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.
2: Placebo Comparator 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.

Arms

Assigned Interventions

1: Experimental

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.

2: Placebo Comparator

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.

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

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

Israel
NICU, Department of Neonatology, Bnai Zion Medical Center
Haifa, Israel, 31048