Lactulose Supplementation in Premature Infants

NCT00616876 | Completed Phase 2

• 2 other identifiers: BZ-23/04LacPre18
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotizing Enterocolitis; Sepsis

Keywords

lactulose; prebiotic; premature infant; enteral feeding; stools; lactobacillus; nutrition; growth

Outcome Measures

Primary Outcomes (1)

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

  1.5 years

Secondary Outcomes (1)

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

  1.5 years

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Lactulose

2

PLACEBO COMPARATOR

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

Dietary Supplement: Dextrose

Interventions

Lactulose DRUG

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.

1

Dextrose DIETARY_SUPPLEMENT

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.

2

Eligibility Criteria

• Age: 23 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Premature infants were recruited based on the following criteria:
• 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.

You may not qualify if:

• Major congenital malformations and parental refusal.

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

Study Sites (1)

NICU, Department of Neonatology, Bnai Zion Medical Center

Haifa, 31048, Israel

Location

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MeSH Terms

Conditions

Enterocolitis, Necrotizing; Sepsis; Premature Birth

Interventions

Lactulose; Glucose

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Hexoses; Monosaccharides

Study Officials

• Arieh Riskin, MD

  Department of Neonatology, Bnai Zion Medical Center

  PRINCIPAL INVESTIGATOR

• Ron Shaoul, MD

  Department of Pediatrics, Pediatric Gastroenterology, Bnai Zion Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: February 15, 2008
• Study Start: February 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: January 1, 2007
• Last Updated: February 15, 2008

Record last verified: 2008-02

Locations

IL (1)