Infantile Colic: Crying Time Reduction With a Whey Hydrolysate: A Double-Blind, Randomized, Placebo-Controlled Trial
To determine the effectiveness of whey hydrolysate formula in the treatment of infantile colic in a primary care setting in the Netherlands. Randomized, double-blind, parallel trial with a 1-week qualification period and a 1-week intervention period. Participants. Forty-three healthy, thriving, form...
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Veröffentlicht in: | Pediatrics (Evanston) 2000-12, Vol.106 (6), p.1349-1354 |
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creator | Lucassen, Peter L. B. J Assendelft, Willem J. J Gubbels, Jan W van Eijk, Jacques ThM Douwes, Adriaan C |
description | To determine the effectiveness of whey hydrolysate formula in the treatment of infantile colic in a primary care setting in the Netherlands.
Randomized, double-blind, parallel trial with a 1-week qualification period and a 1-week intervention period. Participants. Forty-three healthy, thriving, formula-fed infants, 3 hours per day on at least 3 days per week. Infants were randomized to whey hydrolysate formula (n = 23) or standard formula (n = 20).
Difference in duration of crying (minutes per day) between qualification week and intervention week.
Analysis according to the intention to treat principle showed a difference in the decrease of crying duration of 63 minutes per day [95% confidence interval: 1-127 minutes per day] in favor of the whey hydrolysate formula. Five infants did not complete the trial. The scope of the study was not sufficient to expect significant differences in the subgroup analyses.
An extensively hydrolyzed whey formula is effective in reducing the duration of crying in a primary care setting. |
doi_str_mv | 10.1542/peds.106.6.1349 |
format | Article |
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Randomized, double-blind, parallel trial with a 1-week qualification period and a 1-week intervention period. Participants. Forty-three healthy, thriving, formula-fed infants, <6 months old, crying >3 hours per day on at least 3 days per week. Infants were randomized to whey hydrolysate formula (n = 23) or standard formula (n = 20).
Difference in duration of crying (minutes per day) between qualification week and intervention week.
Analysis according to the intention to treat principle showed a difference in the decrease of crying duration of 63 minutes per day [95% confidence interval: 1-127 minutes per day] in favor of the whey hydrolysate formula. Five infants did not complete the trial. The scope of the study was not sufficient to expect significant differences in the subgroup analyses.
An extensively hydrolyzed whey formula is effective in reducing the duration of crying in a primary care setting.</description><identifier>ISSN: 0031-4005</identifier><identifier>EISSN: 1098-4275</identifier><identifier>DOI: 10.1542/peds.106.6.1349</identifier><identifier>PMID: 11099588</identifier><identifier>CODEN: PEDIAU</identifier><language>eng</language><publisher>Elk Grove Village, IL: Am Acad Pediatrics</publisher><subject>Babies ; Behavior ; Biological and medical sciences ; Clinical trials ; Colic ; Colic - etiology ; Colic - prevention & control ; Colic in infants ; Crying ; Diet therapy ; Double-Blind Method ; Drug therapy ; Female ; Food and nutrition ; Food Hypersensitivity - complications ; Food Hypersensitivity - prevention & control ; Gastroenterology. Liver. Pancreas. Abdomen ; Health aspects ; Humans ; Infant ; Infant Food - analysis ; Infants ; Male ; Medical sciences ; Milk Proteins - analysis ; Milk Proteins - pharmacology ; Other diseases. Semiology ; Pediatrics ; Primary care ; Protein Hydrolysates - analysis ; Protein Hydrolysates - pharmacology ; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus ; Whey ; Whey Proteins</subject><ispartof>Pediatrics (Evanston), 2000-12, Vol.106 (6), p.1349-1354</ispartof><rights>2001 INIST-CNRS</rights><rights>COPYRIGHT 2000 American Academy of Pediatrics</rights><rights>COPYRIGHT 2000 American Academy of Pediatrics</rights><rights>Copyright American Academy of Pediatrics Dec 2000</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c533t-4dbee72af475a5d9f3575aef378f25a91362882eb4ca51726242c915c360a2b3</citedby><cites>FETCH-LOGICAL-c533t-4dbee72af475a5d9f3575aef378f25a91362882eb4ca51726242c915c360a2b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=835612$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11099588$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lucassen, Peter L. B. J</creatorcontrib><creatorcontrib>Assendelft, Willem J. J</creatorcontrib><creatorcontrib>Gubbels, Jan W</creatorcontrib><creatorcontrib>van Eijk, Jacques ThM</creatorcontrib><creatorcontrib>Douwes, Adriaan C</creatorcontrib><title>Infantile Colic: Crying Time Reduction With a Whey Hydrolysate: A Double-Blind, Randomized, Placebo-Controlled Trial</title><title>Pediatrics (Evanston)</title><addtitle>Pediatrics</addtitle><description>To determine the effectiveness of whey hydrolysate formula in the treatment of infantile colic in a primary care setting in the Netherlands.
Randomized, double-blind, parallel trial with a 1-week qualification period and a 1-week intervention period. Participants. Forty-three healthy, thriving, formula-fed infants, <6 months old, crying >3 hours per day on at least 3 days per week. Infants were randomized to whey hydrolysate formula (n = 23) or standard formula (n = 20).
Difference in duration of crying (minutes per day) between qualification week and intervention week.
Analysis according to the intention to treat principle showed a difference in the decrease of crying duration of 63 minutes per day [95% confidence interval: 1-127 minutes per day] in favor of the whey hydrolysate formula. Five infants did not complete the trial. The scope of the study was not sufficient to expect significant differences in the subgroup analyses.
An extensively hydrolyzed whey formula is effective in reducing the duration of crying in a primary care setting.</description><subject>Babies</subject><subject>Behavior</subject><subject>Biological and medical sciences</subject><subject>Clinical trials</subject><subject>Colic</subject><subject>Colic - etiology</subject><subject>Colic - prevention & control</subject><subject>Colic in infants</subject><subject>Crying</subject><subject>Diet therapy</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Food and nutrition</subject><subject>Food Hypersensitivity - complications</subject><subject>Food Hypersensitivity - prevention & control</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Health aspects</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant Food - analysis</subject><subject>Infants</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Milk Proteins - analysis</subject><subject>Milk Proteins - pharmacology</subject><subject>Other diseases. Semiology</subject><subject>Pediatrics</subject><subject>Primary care</subject><subject>Protein Hydrolysates - analysis</subject><subject>Protein Hydrolysates - pharmacology</subject><subject>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</subject><subject>Whey</subject><subject>Whey Proteins</subject><issn>0031-4005</issn><issn>1098-4275</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2000</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpt0s9r2zAUB3AzNtas23m3ITYYO8SpJEv-0VvmbW0h0FECPQpZfnZUFCmVbLbsr59CwtqMoIOe4CM98fgmyXuCZ4QzerGBNswIzmf5jGSsepFMCK7KlNGCv0wmGGckZRjzs-RNCA8YY8YL-jo5I1FVvCwnyXBjO2kHbQDVzmh1iWq_1bZHS70GdAftqAbtLLrXwwpJdL-CLbrett6ZbZADXKI5-ubGxkD61WjbTtGdtK1b6z8Q659GKmhcWjs7xBsGWrT0Wpq3yatOmgDvDvt5svzxfVlfp4vbq5t6vkgVz7IhZW0DUFDZsYJL3lZdxmMBXVaUHeWyIllOy5JCw5TkpKA5ZVRVhKssx5I22Xnyef_sxrvHEcIg1jooMEZacGMQBWWMEkIi_PgffHCjt_FrgtIyY5RlPKLpHvXSgNC2c4OXqgcLXhpnoYszFPO8LHhVMRx5eoLH1cJaq1P-y5GPZIDfQy_HEER5tTii01NU7Sbcg4gjrG-P-MWeK-9C8NCJjddr6beCYLFLkdilKB5ykYtdiuKND4d5jM0a2id_iE0Enw5ABiVN56VVOvxzZcZzQp8ar3S_-qU97BppOXitwrPyWeO_jP_dDw</recordid><startdate>20001201</startdate><enddate>20001201</enddate><creator>Lucassen, Peter L. B. 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J ; Gubbels, Jan W ; van Eijk, Jacques ThM ; Douwes, Adriaan C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c533t-4dbee72af475a5d9f3575aef378f25a91362882eb4ca51726242c915c360a2b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2000</creationdate><topic>Babies</topic><topic>Behavior</topic><topic>Biological and medical sciences</topic><topic>Clinical trials</topic><topic>Colic</topic><topic>Colic - etiology</topic><topic>Colic - prevention & control</topic><topic>Colic in infants</topic><topic>Crying</topic><topic>Diet therapy</topic><topic>Double-Blind Method</topic><topic>Drug therapy</topic><topic>Female</topic><topic>Food and nutrition</topic><topic>Food Hypersensitivity - complications</topic><topic>Food Hypersensitivity - prevention & control</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Health aspects</topic><topic>Humans</topic><topic>Infant</topic><topic>Infant Food - analysis</topic><topic>Infants</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Milk Proteins - analysis</topic><topic>Milk Proteins - pharmacology</topic><topic>Other diseases. Semiology</topic><topic>Pediatrics</topic><topic>Primary care</topic><topic>Protein Hydrolysates - analysis</topic><topic>Protein Hydrolysates - pharmacology</topic><topic>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</topic><topic>Whey</topic><topic>Whey Proteins</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lucassen, Peter L. B. J</creatorcontrib><creatorcontrib>Assendelft, Willem J. 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B. J</au><au>Assendelft, Willem J. J</au><au>Gubbels, Jan W</au><au>van Eijk, Jacques ThM</au><au>Douwes, Adriaan C</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Infantile Colic: Crying Time Reduction With a Whey Hydrolysate: A Double-Blind, Randomized, Placebo-Controlled Trial</atitle><jtitle>Pediatrics (Evanston)</jtitle><addtitle>Pediatrics</addtitle><date>2000-12-01</date><risdate>2000</risdate><volume>106</volume><issue>6</issue><spage>1349</spage><epage>1354</epage><pages>1349-1354</pages><issn>0031-4005</issn><eissn>1098-4275</eissn><coden>PEDIAU</coden><abstract>To determine the effectiveness of whey hydrolysate formula in the treatment of infantile colic in a primary care setting in the Netherlands.
Randomized, double-blind, parallel trial with a 1-week qualification period and a 1-week intervention period. Participants. Forty-three healthy, thriving, formula-fed infants, <6 months old, crying >3 hours per day on at least 3 days per week. Infants were randomized to whey hydrolysate formula (n = 23) or standard formula (n = 20).
Difference in duration of crying (minutes per day) between qualification week and intervention week.
Analysis according to the intention to treat principle showed a difference in the decrease of crying duration of 63 minutes per day [95% confidence interval: 1-127 minutes per day] in favor of the whey hydrolysate formula. Five infants did not complete the trial. The scope of the study was not sufficient to expect significant differences in the subgroup analyses.
An extensively hydrolyzed whey formula is effective in reducing the duration of crying in a primary care setting.</abstract><cop>Elk Grove Village, IL</cop><pub>Am Acad Pediatrics</pub><pmid>11099588</pmid><doi>10.1542/peds.106.6.1349</doi><tpages>6</tpages></addata></record> |
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source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
subjects | Babies Behavior Biological and medical sciences Clinical trials Colic Colic - etiology Colic - prevention & control Colic in infants Crying Diet therapy Double-Blind Method Drug therapy Female Food and nutrition Food Hypersensitivity - complications Food Hypersensitivity - prevention & control Gastroenterology. Liver. Pancreas. Abdomen Health aspects Humans Infant Infant Food - analysis Infants Male Medical sciences Milk Proteins - analysis Milk Proteins - pharmacology Other diseases. Semiology Pediatrics Primary care Protein Hydrolysates - analysis Protein Hydrolysates - pharmacology Stomach. Duodenum. Small intestine. Colon. Rectum. Anus Whey Whey Proteins |
title | Infantile Colic: Crying Time Reduction With a Whey Hydrolysate: A Double-Blind, Randomized, Placebo-Controlled Trial |
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