Lactulose Supplementation in Premature Infants

Bnai Zion Medical Center

Status and phase: Completed; Phase 2

Conditions: Necrotizing Enterocolitis; Sepsis

Treatments: Dietary Supplement: Dextrose; Drug: Lactulose

Study type: Interventional

Funder types: Other

Identifiers

NCT00616876

BZ-23/04

LacPre18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 23 to 34 weeks old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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28 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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

Treatment:

Drug: Lactulose

2

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Dextrose