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Completed

NCT Number: NCT00616876

Lactulose Supplementation in Premature Infants

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.

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Key information

Conditions

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

Age range

23 week–34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NICU, Department of Neonatology, Bnai Zion Medical Center

Haifa, 31048, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 1.5 years

Secondary outcomes

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

    Time frame: 1.5 years

Sponsors and collaborators

Lead sponsor

Bnai Zion Medical Center

Other Gov

Registry information

Official study title

The Effects of Lactulose Supplementation to Enteral Feedings in Premature Infants - A Pilot Study

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Feb 15, 2008
Registry last updated
Feb 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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