Lactulose Supplementation in Premature Infants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Necrotizing Enterocolitis, Sepsis

Intervention / Treatment
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* Drug: Lactulose
* Dietary Supplement: Dextrose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 23 Weeks
Maximum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Study group will receive 1% lactulose in all their feeds (human milk or preterm formula) | Drug: Lactulose<br>* 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.<br>|
| Placebo Comparator: 2<br>Control group will receive 1% dextrose placebo in all their feeds (human milk or preterm formula). | Dietary Supplement: Dextrose<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lactulose would support the early growth of Lactobacilli in the stools of premature infants |  | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lactulose would also improve nutritional status and decrease NEC and late-onset sepsis in preterm infants |  | 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lactulose, prebiotic, premature infant, enteral feeding, stools, lactobacillus, nutrition, growth