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| ID | Type | Description | Link |
|---|---|---|---|
| LacPre18 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Study group will receive 1% lactulose in all their feeds (human milk or preterm formula) |
|
| 2 | Placebo Comparator | Control group will receive 1% dextrose placebo in all their feeds (human milk or preterm formula). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactulose | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| lactulose would support the early growth of Lactobacilli in the stools of premature infants | 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| lactulose would also improve nutritional status and decrease NEC and late-onset sepsis in preterm infants | 1.5 years |
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Inclusion Criteria:
Premature infants were recruited based on the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arieh Riskin, MD | Department of Neonatology, Bnai Zion Medical Center | Principal Investigator |
| Ron Shaoul, MD | Department of Pediatrics, Pediatric Gastroenterology, Bnai Zion Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NICU, Department of Neonatology, Bnai Zion Medical Center | Haifa | 31048 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7463467 | Background | Rotimi VO, Duerden BI. The development of the bacterial flora in normal neonates. J Med Microbiol. 1981 Feb;14(1):51-62. doi: 10.1099/00222615-14-1-51. | |
| 10569223 | Background | Orrhage K, Nord CE. Factors controlling the bacterial colonization of the intestine in breastfed infants. Acta Paediatr Suppl. 1999 Aug;88(430):47-57. doi: 10.1111/j.1651-2227.1999.tb01300.x. |
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| D018805 | Sepsis |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D007792 | Lactulose |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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|
| Dextrose | Dietary Supplement | 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. |
|
| 6513816 | Background | Benno Y, Sawada K, Mitsuoka T. The intestinal microflora of infants: composition of fecal flora in breast-fed and bottle-fed infants. Microbiol Immunol. 1984;28(9):975-86. doi: 10.1111/j.1348-0421.1984.tb00754.x. |
| 12583961 | Background | Guarner F, Malagelada JR. Gut flora in health and disease. Lancet. 2003 Feb 8;361(9356):512-9. doi: 10.1016/S0140-6736(03)12489-0. |
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| 14580749 | Background | Costalos C, Skouteri V, Gounaris A, Sevastiadou S, Triandafilidou A, Ekonomidou C, Kontaxaki F, Petrochilou V. Enteral feeding of premature infants with Saccharomyces boulardii. Early Hum Dev. 2003 Nov;74(2):89-96. doi: 10.1016/s0378-3782(03)00090-2. |
| 10575148 | Background | Hoyos AB. Reduced incidence of necrotizing enterocolitis associated with enteral administration of Lactobacillus acidophilus and Bifidobacterium infantis to neonates in an intensive care unit. Int J Infect Dis. 1999 Summer;3(4):197-202. doi: 10.1016/s1201-9712(99)90024-3. |
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| 16214763 | Background | Knol J, Boehm G, Lidestri M, Negretti F, Jelinek J, Agosti M, Stahl B, Marini A, Mosca F. Increase of faecal bifidobacteria due to dietary oligosaccharides induces a reduction of clinically relevant pathogen germs in the faeces of formula-fed preterm infants. Acta Paediatr Suppl. 2005 Oct;94(449):31-3. doi: 10.1111/j.1651-2227.2005.tb02152.x. |
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| 13646664 | Background | MACGILLIVRAY PC, FINLAY HV, BINNS TB. Use of lactulose to create a preponderance of Lactobacilli in the intestine of bottle-fed infants. Scott Med J. 1959 Apr;4(4):182-9. doi: 10.1177/003693305900400405. No abstract available. |
| D007410 |
| Intestinal Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000073893 |
| Sugars |
| D006601 | Hexoses |
| D009005 | Monosaccharides |