Necrotizing Enterocolitis, Sepsis
Conditions
Keywords
lactulose, prebiotic, premature infant, enteral feeding, stools, lactobacillus, nutrition, growth
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.
Interventions
DRUGLactulose
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.
DIETARY_SUPPLEMENTDextrose
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.
Sponsors
Bnai Zion Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 34 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| lactulose would support the early growth of Lactobacilli in the stools of premature infants | 1.5 years |
Secondary
| Measure | Time frame |
|---|---|
| lactulose would also improve nutritional status and decrease NEC and late-onset sepsis in preterm infants | 1.5 years |
Countries
Israel
Outcome results
None listed