Randomized Trial of Human Milk Cream as a Supplement to Standard Fortification of an Exclusive Human Milk-Based Diet in Infants 750-1250 g Birth Weight
Objective To evaluate whether premature infants who received an exclusive human milk (HM)-based diet and a HM-derived cream supplement (cream) would have weight gain (g/kg/d) at least as good as infants receiving a standard feeding regimen (control). Study design In a prospective noninferiority, ran...
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| Veröffentlicht in: | The Journal of pediatrics 2014-11, Vol.165 (5), p.915-920 |
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| container_title | The Journal of pediatrics |
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| creator | Hair, Amy B., MD Blanco, Cynthia L., MD Moreira, Alvaro G., MD Hawthorne, Keli M., MS, RD Lee, Martin L., PhD Rechtman, David J., MD Abrams, Steven A., MD |
| description | Objective To evaluate whether premature infants who received an exclusive human milk (HM)-based diet and a HM-derived cream supplement (cream) would have weight gain (g/kg/d) at least as good as infants receiving a standard feeding regimen (control). Study design In a prospective noninferiority, randomized, unmasked study, infants with a birth weight 750-1250 g were randomly assigned to the control or cream group. The control group received mother's own milk or donor HM with donor HM-derived fortifier. The cream group received a HM-derived cream supplement if the energy density of the HM tested |
| doi_str_mv | 10.1016/j.jpeds.2014.07.005 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1629956284</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>1_s2_0_S0022347614006271</els_id><sourcerecordid>1629956284</sourcerecordid><originalsourceid>FETCH-LOGICAL-c459t-bc5e5803606746624ede36ff93d612188b8f77c4338e29c86fd72d67650b11f53</originalsourceid><addsrcrecordid>eNqFksFu1DAURSMEokPhC5CQl2wyPNuxnSxAokNLKxUhMUUsLY_z0nqaOMF2KsqXsORb-DI8TEGIDStv7nnX9nlF8ZTCkgKVL7bL7YRtXDKg1RLUEkDcKxYUGlXKmvP7xQKAsZJXSh4Uj2LcAkBTATwsDpigHISii-LbB-PbcXBfsSUXwZmejB05nQfjyTvXX5NVQDMQE4kh63maehzQJ5JGsk4ZNKElJ2NIrnPWJDf6HZ3R4y-2n6O7wb9GlUcm5pI3DhNxnpz5zvgUiRJQUibgx_dLcuRCuiKf0F1epcfFg870EZ_cnYfFx5Pji9Vpef7-7dnq9XlpK9GkcmMFihq4BKkqKVmFLXLZdQ1vJWW0rjd1p5StOK-RNbaWXatYK5UUsKG0E_yweL6fO4Xx84wx6cFFi31vPI5z1FSyphGS1VWO8n3UhjHGgJ2eghtMuNUU9E6J3upfSvROiQals5JMPbsrmDcDtn-Y3w5y4OU-gPmZNw6Djtaht9i6gDbpdnT_KXj1D29757OQ_hpvMW7HOfj8g5rqyDTo9W4rdktB8y5Ili_wEx1nsbQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1629956284</pqid></control><display><type>article</type><title>Randomized Trial of Human Milk Cream as a Supplement to Standard Fortification of an Exclusive Human Milk-Based Diet in Infants 750-1250 g Birth Weight</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals Complete</source><creator>Hair, Amy B., MD ; Blanco, Cynthia L., MD ; Moreira, Alvaro G., MD ; Hawthorne, Keli M., MS, RD ; Lee, Martin L., PhD ; Rechtman, David J., MD ; Abrams, Steven A., MD</creator><creatorcontrib>Hair, Amy B., MD ; Blanco, Cynthia L., MD ; Moreira, Alvaro G., MD ; Hawthorne, Keli M., MS, RD ; Lee, Martin L., PhD ; Rechtman, David J., MD ; Abrams, Steven A., MD</creatorcontrib><description>Objective To evaluate whether premature infants who received an exclusive human milk (HM)-based diet and a HM-derived cream supplement (cream) would have weight gain (g/kg/d) at least as good as infants receiving a standard feeding regimen (control). Study design In a prospective noninferiority, randomized, unmasked study, infants with a birth weight 750-1250 g were randomly assigned to the control or cream group. The control group received mother's own milk or donor HM with donor HM-derived fortifier. The cream group received a HM-derived cream supplement if the energy density of the HM tested <20 kcal/oz using a near infrared HM analyzer. Infants were continued on the protocol until 36 weeks postmenstrual age. Primary outcomes included growth velocities and amount of donor HM-derived fortifier used. The hypothesis of noninferiority was established if the lower bound of the one-sided 95% CI for the difference in weight velocities exceeded −3 g/kg/day. Results There were no differences between groups in baseline demographics for the 78 infants studied except racial distribution ( P = .02). The cream group (n = 39) had superior weight (14.0 ± 2.5 vs 12.4 ± 3.0 g/kg/d, P = .03) and length (1.03 ± 0.33 vs 0.83 ± 0.41 cm/wk, P = .02) velocity compared with the control group (n = 39). There were no significant differences in amount of fortifier used between study groups. The 1-sided 95% lower bound of the CI for the difference in mean velocity (cream-control) was 0.38 g/kg/d. Conclusions Premature infants who received HM-derived cream to fortified HM had improved weight and length velocity compared with the control group. HM-derived cream should be considered an adjunctive supplement to an exclusive HM-based diet to improve growth rates in premature infants.</description><identifier>ISSN: 0022-3476</identifier><identifier>EISSN: 1097-6833</identifier><identifier>DOI: 10.1016/j.jpeds.2014.07.005</identifier><identifier>PMID: 25130571</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Birth Weight ; Body Weight ; Dietary Supplements ; Female ; Food, Fortified ; Humans ; Infant ; Infant, Premature - growth & development ; Infant, Very Low Birth Weight - growth & development ; Male ; Milk, Human - physiology ; Pediatrics ; Prospective Studies ; Weight Gain - physiology</subject><ispartof>The Journal of pediatrics, 2014-11, Vol.165 (5), p.915-920</ispartof><rights>The Authors</rights><rights>2014 The Authors</rights><rights>Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c459t-bc5e5803606746624ede36ff93d612188b8f77c4338e29c86fd72d67650b11f53</citedby><cites>FETCH-LOGICAL-c459t-bc5e5803606746624ede36ff93d612188b8f77c4338e29c86fd72d67650b11f53</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0022347614006271$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25130571$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hair, Amy B., MD</creatorcontrib><creatorcontrib>Blanco, Cynthia L., MD</creatorcontrib><creatorcontrib>Moreira, Alvaro G., MD</creatorcontrib><creatorcontrib>Hawthorne, Keli M., MS, RD</creatorcontrib><creatorcontrib>Lee, Martin L., PhD</creatorcontrib><creatorcontrib>Rechtman, David J., MD</creatorcontrib><creatorcontrib>Abrams, Steven A., MD</creatorcontrib><title>Randomized Trial of Human Milk Cream as a Supplement to Standard Fortification of an Exclusive Human Milk-Based Diet in Infants 750-1250 g Birth Weight</title><title>The Journal of pediatrics</title><addtitle>J Pediatr</addtitle><description>Objective To evaluate whether premature infants who received an exclusive human milk (HM)-based diet and a HM-derived cream supplement (cream) would have weight gain (g/kg/d) at least as good as infants receiving a standard feeding regimen (control). Study design In a prospective noninferiority, randomized, unmasked study, infants with a birth weight 750-1250 g were randomly assigned to the control or cream group. The control group received mother's own milk or donor HM with donor HM-derived fortifier. The cream group received a HM-derived cream supplement if the energy density of the HM tested <20 kcal/oz using a near infrared HM analyzer. Infants were continued on the protocol until 36 weeks postmenstrual age. Primary outcomes included growth velocities and amount of donor HM-derived fortifier used. The hypothesis of noninferiority was established if the lower bound of the one-sided 95% CI for the difference in weight velocities exceeded −3 g/kg/day. Results There were no differences between groups in baseline demographics for the 78 infants studied except racial distribution ( P = .02). The cream group (n = 39) had superior weight (14.0 ± 2.5 vs 12.4 ± 3.0 g/kg/d, P = .03) and length (1.03 ± 0.33 vs 0.83 ± 0.41 cm/wk, P = .02) velocity compared with the control group (n = 39). There were no significant differences in amount of fortifier used between study groups. The 1-sided 95% lower bound of the CI for the difference in mean velocity (cream-control) was 0.38 g/kg/d. Conclusions Premature infants who received HM-derived cream to fortified HM had improved weight and length velocity compared with the control group. HM-derived cream should be considered an adjunctive supplement to an exclusive HM-based diet to improve growth rates in premature infants.</description><subject>Birth Weight</subject><subject>Body Weight</subject><subject>Dietary Supplements</subject><subject>Female</subject><subject>Food, Fortified</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant, Premature - growth & development</subject><subject>Infant, Very Low Birth Weight - growth & development</subject><subject>Male</subject><subject>Milk, Human - physiology</subject><subject>Pediatrics</subject><subject>Prospective Studies</subject><subject>Weight Gain - physiology</subject><issn>0022-3476</issn><issn>1097-6833</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFksFu1DAURSMEokPhC5CQl2wyPNuxnSxAokNLKxUhMUUsLY_z0nqaOMF2KsqXsORb-DI8TEGIDStv7nnX9nlF8ZTCkgKVL7bL7YRtXDKg1RLUEkDcKxYUGlXKmvP7xQKAsZJXSh4Uj2LcAkBTATwsDpigHISii-LbB-PbcXBfsSUXwZmejB05nQfjyTvXX5NVQDMQE4kh63maehzQJ5JGsk4ZNKElJ2NIrnPWJDf6HZ3R4y-2n6O7wb9GlUcm5pI3DhNxnpz5zvgUiRJQUibgx_dLcuRCuiKf0F1epcfFg870EZ_cnYfFx5Pji9Vpef7-7dnq9XlpK9GkcmMFihq4BKkqKVmFLXLZdQ1vJWW0rjd1p5StOK-RNbaWXatYK5UUsKG0E_yweL6fO4Xx84wx6cFFi31vPI5z1FSyphGS1VWO8n3UhjHGgJ2eghtMuNUU9E6J3upfSvROiQals5JMPbsrmDcDtn-Y3w5y4OU-gPmZNw6Djtaht9i6gDbpdnT_KXj1D29757OQ_hpvMW7HOfj8g5rqyDTo9W4rdktB8y5Ili_wEx1nsbQ</recordid><startdate>20141101</startdate><enddate>20141101</enddate><creator>Hair, Amy B., MD</creator><creator>Blanco, Cynthia L., MD</creator><creator>Moreira, Alvaro G., MD</creator><creator>Hawthorne, Keli M., MS, RD</creator><creator>Lee, Martin L., PhD</creator><creator>Rechtman, David J., MD</creator><creator>Abrams, Steven A., MD</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20141101</creationdate><title>Randomized Trial of Human Milk Cream as a Supplement to Standard Fortification of an Exclusive Human Milk-Based Diet in Infants 750-1250 g Birth Weight</title><author>Hair, Amy B., MD ; Blanco, Cynthia L., MD ; Moreira, Alvaro G., MD ; Hawthorne, Keli M., MS, RD ; Lee, Martin L., PhD ; Rechtman, David J., MD ; Abrams, Steven A., MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c459t-bc5e5803606746624ede36ff93d612188b8f77c4338e29c86fd72d67650b11f53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Birth Weight</topic><topic>Body Weight</topic><topic>Dietary Supplements</topic><topic>Female</topic><topic>Food, Fortified</topic><topic>Humans</topic><topic>Infant</topic><topic>Infant, Premature - growth & development</topic><topic>Infant, Very Low Birth Weight - growth & development</topic><topic>Male</topic><topic>Milk, Human - physiology</topic><topic>Pediatrics</topic><topic>Prospective Studies</topic><topic>Weight Gain - physiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hair, Amy B., MD</creatorcontrib><creatorcontrib>Blanco, Cynthia L., MD</creatorcontrib><creatorcontrib>Moreira, Alvaro G., MD</creatorcontrib><creatorcontrib>Hawthorne, Keli M., MS, RD</creatorcontrib><creatorcontrib>Lee, Martin L., PhD</creatorcontrib><creatorcontrib>Rechtman, David J., MD</creatorcontrib><creatorcontrib>Abrams, Steven A., MD</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>The Journal of pediatrics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hair, Amy B., MD</au><au>Blanco, Cynthia L., MD</au><au>Moreira, Alvaro G., MD</au><au>Hawthorne, Keli M., MS, RD</au><au>Lee, Martin L., PhD</au><au>Rechtman, David J., MD</au><au>Abrams, Steven A., MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized Trial of Human Milk Cream as a Supplement to Standard Fortification of an Exclusive Human Milk-Based Diet in Infants 750-1250 g Birth Weight</atitle><jtitle>The Journal of pediatrics</jtitle><addtitle>J Pediatr</addtitle><date>2014-11-01</date><risdate>2014</risdate><volume>165</volume><issue>5</issue><spage>915</spage><epage>920</epage><pages>915-920</pages><issn>0022-3476</issn><eissn>1097-6833</eissn><abstract>Objective To evaluate whether premature infants who received an exclusive human milk (HM)-based diet and a HM-derived cream supplement (cream) would have weight gain (g/kg/d) at least as good as infants receiving a standard feeding regimen (control). Study design In a prospective noninferiority, randomized, unmasked study, infants with a birth weight 750-1250 g were randomly assigned to the control or cream group. The control group received mother's own milk or donor HM with donor HM-derived fortifier. The cream group received a HM-derived cream supplement if the energy density of the HM tested <20 kcal/oz using a near infrared HM analyzer. Infants were continued on the protocol until 36 weeks postmenstrual age. Primary outcomes included growth velocities and amount of donor HM-derived fortifier used. The hypothesis of noninferiority was established if the lower bound of the one-sided 95% CI for the difference in weight velocities exceeded −3 g/kg/day. Results There were no differences between groups in baseline demographics for the 78 infants studied except racial distribution ( P = .02). The cream group (n = 39) had superior weight (14.0 ± 2.5 vs 12.4 ± 3.0 g/kg/d, P = .03) and length (1.03 ± 0.33 vs 0.83 ± 0.41 cm/wk, P = .02) velocity compared with the control group (n = 39). There were no significant differences in amount of fortifier used between study groups. The 1-sided 95% lower bound of the CI for the difference in mean velocity (cream-control) was 0.38 g/kg/d. Conclusions Premature infants who received HM-derived cream to fortified HM had improved weight and length velocity compared with the control group. HM-derived cream should be considered an adjunctive supplement to an exclusive HM-based diet to improve growth rates in premature infants.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>25130571</pmid><doi>10.1016/j.jpeds.2014.07.005</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | The Journal of pediatrics, 2014-11, Vol.165 (5), p.915-920 |
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| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Birth Weight Body Weight Dietary Supplements Female Food, Fortified Humans Infant Infant, Premature - growth & development Infant, Very Low Birth Weight - growth & development Male Milk, Human - physiology Pediatrics Prospective Studies Weight Gain - physiology |
| title | Randomized Trial of Human Milk Cream as a Supplement to Standard Fortification of an Exclusive Human Milk-Based Diet in Infants 750-1250 g Birth Weight |
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