Lactulose Supplementation in Premature Infants
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|ClinicalTrials.gov Identifier: NCT00616876|
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : February 15, 2008
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|Condition or disease||Intervention/treatment||Phase|
|Necrotizing Enterocolitis Sepsis||Drug: Lactulose Dietary Supplement: Dextrose||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Effects of Lactulose Supplementation to Enteral Feedings in Premature Infants - A Pilot Study|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||January 2007|
Study group will receive 1% lactulose in all their feeds (human milk or preterm formula)
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.
Placebo Comparator: 2
Control group will receive 1% dextrose placebo in all their feeds (human milk or preterm formula).
Dietary Supplement: 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.
- lactulose would support the early growth of Lactobacilli in the stools of premature infants [ Time Frame: 1.5 years ]
- lactulose would also improve nutritional status and decrease NEC and late-onset sepsis in preterm infants [ Time Frame: 1.5 years ]
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|Ages Eligible for Study:||23 Weeks to 34 Weeks (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- Major congenital malformations and parental refusal.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616876
|NICU, Department of Neonatology, Bnai Zion Medical Center|
|Haifa, Israel, 31048|
|Principal Investigator:||Arieh Riskin, MD||Department of Neonatology, Bnai Zion Medical Center|
|Principal Investigator:||Ron Shaoul, MD||Department of Pediatrics, Pediatric Gastroenterology, Bnai Zion Medical Center|
|Responsible Party:||Arieh Riskin MD, Bnai Zion Medical Center|
|Other Study ID Numbers:||
|First Posted:||February 15, 2008 Key Record Dates|
|Last Update Posted:||February 15, 2008|
|Last Verified:||February 2008|
Obstetric Labor, Premature
Obstetric Labor Complications
Female Urogenital Diseases and Pregnancy Complications
Digestive System Diseases