Lactulose Supplementation in Premature Infants

Sponsor

Bnai Zion Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00616876

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Necrotizing Enterocolitis Sepsis	Drug: Lactulose Dietary Supplement: Dextrose	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

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

Study Start Date :

Feb 1, 2005

Actual Primary Completion Date :

Aug 1, 2006

Actual Study Completion Date :

Jan 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

lactulose would support the early growth of Lactobacilli in the stools of premature infants [1.5 years]

Secondary Outcome Measures

lactulose would also improve nutritional status and decrease NEC and late-onset sepsis in preterm infants [1.5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

23 Weeks to 34 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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