Study Results
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Basic Information
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COMPLETED
PHASE2
28 participants
INTERVENTIONAL
2005-02-28
2007-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
TRIPLE
Study Groups
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1
Study group will receive 1% lactulose in all their feeds (human milk or preterm formula)
Lactulose
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.
2
Control group will receive 1% dextrose placebo in all their feeds (human milk or preterm formula).
Dextrose
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.
Interventions
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Lactulose
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
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.
Eligibility Criteria
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Inclusion 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
23 Weeks
34 Weeks
ALL
No
Sponsors
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Bnai Zion Medical Center
OTHER_GOV
Responsible Party
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Bnai Zion Medical Center
Principal Investigators
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Arieh Riskin, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Neonatology, Bnai Zion Medical Center
Ron Shaoul, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics, Pediatric Gastroenterology, Bnai Zion Medical Center
Locations
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NICU, Department of Neonatology, Bnai Zion Medical Center
Haifa, , Israel
Countries
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References
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Other Identifiers
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LacPre18
Identifier Type: -
Identifier Source: secondary_id
BZ-23/04
Identifier Type: -
Identifier Source: org_study_id
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