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Lactulose Supplementation in Premature Infants

Primary Purpose

Necrotizing Enterocolitis, Sepsis

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Lactulose
Dextrose
Sponsored by
Bnai Zion Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Necrotizing Enterocolitis focused on measuring lactulose, prebiotic, premature infant, enteral feeding, stools, lactobacillus, nutrition, growth

Eligibility Criteria

23 Weeks - 34 Weeks (Child)All SexesDoes not accept 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.

Sites / Locations

  • NICU, Department of Neonatology, Bnai Zion Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Study group will receive 1% lactulose in all their feeds (human milk or preterm formula)

Control group will receive 1% dextrose placebo in all their feeds (human milk or preterm formula).

Outcomes

Primary Outcome Measures

lactulose would support the early growth of Lactobacilli in the stools of premature infants

Secondary Outcome Measures

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

Full Information

First Posted
February 5, 2008
Last Updated
February 14, 2008
Sponsor
Bnai Zion Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00616876
Brief Title
Lactulose Supplementation in Premature Infants
Official Title
The Effects of Lactulose Supplementation to Enteral Feedings in Premature Infants - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bnai Zion Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Enterocolitis, Sepsis
Keywords
lactulose, prebiotic, premature infant, enteral feeding, stools, lactobacillus, nutrition, growth

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Study group will receive 1% lactulose in all their feeds (human milk or preterm formula)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Control group will receive 1% dextrose placebo in all their feeds (human milk or preterm formula).
Intervention Type
Drug
Intervention Name(s)
Lactulose
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dextrose
Intervention Description
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.
Primary Outcome Measure Information:
Title
lactulose would support the early growth of Lactobacilli in the stools of premature infants
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
lactulose would also improve nutritional status and decrease NEC and late-onset sepsis in preterm infants
Time Frame
1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arieh Riskin, MD
Organizational Affiliation
Department of Neonatology, Bnai Zion Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ron Shaoul, MD
Organizational Affiliation
Department of Pediatrics, Pediatric Gastroenterology, Bnai Zion Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NICU, Department of Neonatology, Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel

12. IPD Sharing Statement

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Lactulose Supplementation in Premature Infants

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