Application effect of extensively hydrolyzed milk protein formula and follow-up in preterm children with a gestational age of less than 34 weeks: study protocol for a randomized controlled trial
The average incidence of preterm birth in the world is up to 11.1 %, and deaths of preterm children account for more than 50 % of neonatal deaths. Gastrointestinal function of preterm children with a gestational age less than 34 weeks is immaturely developed. For preterm children who can only be fed...
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| Veröffentlicht in: | Current controlled trials in cardiovascular medicine 2015-11, Vol.16 (1), p.498-498, Article 498 |
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| creator | Yin, Li-Ping Qian, Li-Juan Zhu, Huan Chen, Yan Li, Han Han, Ji-Nan Qiao, Li-Xing |
| description | The average incidence of preterm birth in the world is up to 11.1 %, and deaths of preterm children account for more than 50 % of neonatal deaths. Gastrointestinal function of preterm children with a gestational age less than 34 weeks is immaturely developed. For preterm children who can only be fed with formula due to their mothers' sickness, choosing a suitable formula can not only meet the high nutritional needs of preterm children, but also solve their low gastrointestinal tolerability, and is thus very important.
The study is a prospective, randomized, single-blind and controlled clinical trial. Preterm children with a gestational age less than 34 weeks meeting the inclusion criteria who cannot be breastfed will be included. To demonstrate the application effect of extensively hydrolyzed milk protein formula on the target population, preterm children will be randomized into two groups, 185 subjects in each group. The observation group will be fed with extensively hydrolyzed milk protein (100 % whey protein) formula, while the control group will be fed with preterm children's formula until the children are discharged from the neonatal intensive care unit (NICU). All the formula involved in this study will be from Dumex. After discharge, both groups will be uniformly fed with formula for 0 to 6-month-old infants. For statistical analysis, a chi-square test and Student's t test will be applied using SAS 9.4.
This will be the first randomized controlled clinical study with long-term observation of the growth and development of preterm children during the NICU stay and at 3-month follow-up after discharge from the NICU. Results from this study will be used to determine whether the extensively hydrolyzed formula is more suitable for the low gastrointestinal tolerability of preterm children, and also whether feeding preterm children who are fed with such formula during the NICU stay with ordinary infant formula after discharge from the NICU would affect the normal growth and development of preterm children in the early stage of their lives.
This study was registered with the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/ ) with number ChiCTR-IOR-14005696 , on December 22, 2014. |
| doi_str_mv | 10.1186/s13063-015-1030-5 |
| format | Article |
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The study is a prospective, randomized, single-blind and controlled clinical trial. Preterm children with a gestational age less than 34 weeks meeting the inclusion criteria who cannot be breastfed will be included. To demonstrate the application effect of extensively hydrolyzed milk protein formula on the target population, preterm children will be randomized into two groups, 185 subjects in each group. The observation group will be fed with extensively hydrolyzed milk protein (100 % whey protein) formula, while the control group will be fed with preterm children's formula until the children are discharged from the neonatal intensive care unit (NICU). All the formula involved in this study will be from Dumex. After discharge, both groups will be uniformly fed with formula for 0 to 6-month-old infants. For statistical analysis, a chi-square test and Student's t test will be applied using SAS 9.4.
This will be the first randomized controlled clinical study with long-term observation of the growth and development of preterm children during the NICU stay and at 3-month follow-up after discharge from the NICU. Results from this study will be used to determine whether the extensively hydrolyzed formula is more suitable for the low gastrointestinal tolerability of preterm children, and also whether feeding preterm children who are fed with such formula during the NICU stay with ordinary infant formula after discharge from the NICU would affect the normal growth and development of preterm children in the early stage of their lives.
This study was registered with the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/ ) with number ChiCTR-IOR-14005696 , on December 22, 2014.</description><identifier>ISSN: 1745-6215</identifier><identifier>EISSN: 1745-6215</identifier><identifier>DOI: 10.1186/s13063-015-1030-5</identifier><identifier>PMID: 26537897</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Amino acids ; Bottle Feeding ; Breastfeeding & lactation ; Child Development ; China ; Clinical Protocols ; Clinical trials ; Enteral nutrition ; Fetuses ; Gestational Age ; Health aspects ; Humans ; Infant ; Infant Formula - administration & dosage ; Infant, Newborn ; Infant, Premature ; Infants (Premature) ; Influence ; Intensive Care Units, Neonatal ; Intensive Care, Neonatal ; Metabolism ; Milk proteins ; Milk Proteins - administration & dosage ; Milk Proteins - adverse effects ; Mortality ; Mothers ; Newborn babies ; Nosocomial infections ; Nutrition ; Nutritional Status ; Parenteral nutrition ; Pediatrics ; Peptides ; Premature birth ; Prospective Studies ; Protein Hydrolysates - administration & dosage ; Protein Hydrolysates - adverse effects ; Proteins ; Research Design ; Single-Blind Method ; Study Protocol ; Time Factors ; Treatment Outcome</subject><ispartof>Current controlled trials in cardiovascular medicine, 2015-11, Vol.16 (1), p.498-498, Article 498</ispartof><rights>COPYRIGHT 2015 BioMed Central Ltd.</rights><rights>Yin et al. 2015. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Yin et al. 2015</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c564t-f50f1202ad24404c5f2bb1faf852474edc4e36f451720f131e28829dfa2be7e63</citedby><cites>FETCH-LOGICAL-c564t-f50f1202ad24404c5f2bb1faf852474edc4e36f451720f131e28829dfa2be7e63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4632355/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4632355/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26537897$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yin, Li-Ping</creatorcontrib><creatorcontrib>Qian, Li-Juan</creatorcontrib><creatorcontrib>Zhu, Huan</creatorcontrib><creatorcontrib>Chen, Yan</creatorcontrib><creatorcontrib>Li, Han</creatorcontrib><creatorcontrib>Han, Ji-Nan</creatorcontrib><creatorcontrib>Qiao, Li-Xing</creatorcontrib><title>Application effect of extensively hydrolyzed milk protein formula and follow-up in preterm children with a gestational age of less than 34 weeks: study protocol for a randomized controlled trial</title><title>Current controlled trials in cardiovascular medicine</title><addtitle>Trials</addtitle><description>The average incidence of preterm birth in the world is up to 11.1 %, and deaths of preterm children account for more than 50 % of neonatal deaths. Gastrointestinal function of preterm children with a gestational age less than 34 weeks is immaturely developed. For preterm children who can only be fed with formula due to their mothers' sickness, choosing a suitable formula can not only meet the high nutritional needs of preterm children, but also solve their low gastrointestinal tolerability, and is thus very important.
The study is a prospective, randomized, single-blind and controlled clinical trial. Preterm children with a gestational age less than 34 weeks meeting the inclusion criteria who cannot be breastfed will be included. To demonstrate the application effect of extensively hydrolyzed milk protein formula on the target population, preterm children will be randomized into two groups, 185 subjects in each group. The observation group will be fed with extensively hydrolyzed milk protein (100 % whey protein) formula, while the control group will be fed with preterm children's formula until the children are discharged from the neonatal intensive care unit (NICU). All the formula involved in this study will be from Dumex. After discharge, both groups will be uniformly fed with formula for 0 to 6-month-old infants. For statistical analysis, a chi-square test and Student's t test will be applied using SAS 9.4.
This will be the first randomized controlled clinical study with long-term observation of the growth and development of preterm children during the NICU stay and at 3-month follow-up after discharge from the NICU. Results from this study will be used to determine whether the extensively hydrolyzed formula is more suitable for the low gastrointestinal tolerability of preterm children, and also whether feeding preterm children who are fed with such formula during the NICU stay with ordinary infant formula after discharge from the NICU would affect the normal growth and development of preterm children in the early stage of their lives.
This study was registered with the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/ ) with number ChiCTR-IOR-14005696 , on December 22, 2014.</description><subject>Amino acids</subject><subject>Bottle Feeding</subject><subject>Breastfeeding & lactation</subject><subject>Child Development</subject><subject>China</subject><subject>Clinical Protocols</subject><subject>Clinical trials</subject><subject>Enteral nutrition</subject><subject>Fetuses</subject><subject>Gestational Age</subject><subject>Health aspects</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant Formula - administration & dosage</subject><subject>Infant, Newborn</subject><subject>Infant, Premature</subject><subject>Infants (Premature)</subject><subject>Influence</subject><subject>Intensive Care Units, Neonatal</subject><subject>Intensive Care, Neonatal</subject><subject>Metabolism</subject><subject>Milk proteins</subject><subject>Milk Proteins - administration & dosage</subject><subject>Milk Proteins - adverse effects</subject><subject>Mortality</subject><subject>Mothers</subject><subject>Newborn babies</subject><subject>Nosocomial infections</subject><subject>Nutrition</subject><subject>Nutritional Status</subject><subject>Parenteral nutrition</subject><subject>Pediatrics</subject><subject>Peptides</subject><subject>Premature birth</subject><subject>Prospective Studies</subject><subject>Protein Hydrolysates - administration & dosage</subject><subject>Protein Hydrolysates - adverse effects</subject><subject>Proteins</subject><subject>Research Design</subject><subject>Single-Blind Method</subject><subject>Study Protocol</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>1745-6215</issn><issn>1745-6215</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNptUstu1DAUjRCIlsIHsEGW2LBJ8TNOWCCNKl5SJTawtjzO9YxbJw620-nweXwZTqeUFiEvfGWfe87x9amqlwSfEtI2bxNhuGE1JqImmOFaPKqOieSibigRj-_VR9WzlC4w5qxj_Gl1RBvBZNvJ4-rXapq8Mzq7MCKwFkxGwSK4zjAmdwV-j7b7Pga__wk9Gpy_RFMMGdyIbIjD7DXSY19q78OunidULqYIGeKAzNb5PsKIdi5vkUYbSPlGSHukN7DoeEgJ5a0eEeNoB3CZ3qGU535_oxJM8ItM6Y1FJQxuMWHCmIshX8ocnfbPqydW-wQvbveT6vvHD9_OPtfnXz99OVud10Y0PNdWYEsoprqnnGNuhKXrNbHatoJyyaE3HFhjuSCSFiQjQNuWdr3VdA0SGnZSvT_wTvN6KHAoNrRXU3SDjnsVtFMPb0a3VZtwpXjDKBOiELy5JYjhx1yGoQaXDHivRwhzUkQyIlvC5QJ9_Q_0IsyxDC4pKjtR_q-Q_kVttAflRhuKrllI1Ypz2XWSigV1-h9UWT0MrgwTrCvnDxrIocHEkFIEe_dGgtUSPHUInirBU0vw1GL41f3h3HX8SRr7DdY014w</recordid><startdate>20151104</startdate><enddate>20151104</enddate><creator>Yin, Li-Ping</creator><creator>Qian, Li-Juan</creator><creator>Zhu, Huan</creator><creator>Chen, Yan</creator><creator>Li, Han</creator><creator>Han, Ji-Nan</creator><creator>Qiao, Li-Xing</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><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>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20151104</creationdate><title>Application effect of extensively hydrolyzed milk protein formula and follow-up in preterm children with a gestational age of less than 34 weeks: study protocol for a randomized controlled trial</title><author>Yin, Li-Ping ; Qian, Li-Juan ; Zhu, Huan ; Chen, Yan ; Li, Han ; Han, Ji-Nan ; Qiao, Li-Xing</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c564t-f50f1202ad24404c5f2bb1faf852474edc4e36f451720f131e28829dfa2be7e63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Amino acids</topic><topic>Bottle Feeding</topic><topic>Breastfeeding & lactation</topic><topic>Child Development</topic><topic>China</topic><topic>Clinical Protocols</topic><topic>Clinical trials</topic><topic>Enteral nutrition</topic><topic>Fetuses</topic><topic>Gestational Age</topic><topic>Health aspects</topic><topic>Humans</topic><topic>Infant</topic><topic>Infant Formula - administration & dosage</topic><topic>Infant, Newborn</topic><topic>Infant, Premature</topic><topic>Infants (Premature)</topic><topic>Influence</topic><topic>Intensive Care Units, Neonatal</topic><topic>Intensive Care, Neonatal</topic><topic>Metabolism</topic><topic>Milk proteins</topic><topic>Milk Proteins - administration & dosage</topic><topic>Milk Proteins - adverse effects</topic><topic>Mortality</topic><topic>Mothers</topic><topic>Newborn babies</topic><topic>Nosocomial infections</topic><topic>Nutrition</topic><topic>Nutritional Status</topic><topic>Parenteral nutrition</topic><topic>Pediatrics</topic><topic>Peptides</topic><topic>Premature birth</topic><topic>Prospective Studies</topic><topic>Protein Hydrolysates - administration & dosage</topic><topic>Protein Hydrolysates - adverse effects</topic><topic>Proteins</topic><topic>Research Design</topic><topic>Single-Blind Method</topic><topic>Study Protocol</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yin, Li-Ping</creatorcontrib><creatorcontrib>Qian, Li-Juan</creatorcontrib><creatorcontrib>Zhu, Huan</creatorcontrib><creatorcontrib>Chen, Yan</creatorcontrib><creatorcontrib>Li, Han</creatorcontrib><creatorcontrib>Han, Ji-Nan</creatorcontrib><creatorcontrib>Qiao, Li-Xing</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Proquest Nursing & Allied Health Source</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Current controlled trials in cardiovascular medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yin, Li-Ping</au><au>Qian, Li-Juan</au><au>Zhu, Huan</au><au>Chen, Yan</au><au>Li, Han</au><au>Han, Ji-Nan</au><au>Qiao, Li-Xing</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Application effect of extensively hydrolyzed milk protein formula and follow-up in preterm children with a gestational age of less than 34 weeks: study protocol for a randomized controlled trial</atitle><jtitle>Current controlled trials in cardiovascular medicine</jtitle><addtitle>Trials</addtitle><date>2015-11-04</date><risdate>2015</risdate><volume>16</volume><issue>1</issue><spage>498</spage><epage>498</epage><pages>498-498</pages><artnum>498</artnum><issn>1745-6215</issn><eissn>1745-6215</eissn><abstract>The average incidence of preterm birth in the world is up to 11.1 %, and deaths of preterm children account for more than 50 % of neonatal deaths. Gastrointestinal function of preterm children with a gestational age less than 34 weeks is immaturely developed. For preterm children who can only be fed with formula due to their mothers' sickness, choosing a suitable formula can not only meet the high nutritional needs of preterm children, but also solve their low gastrointestinal tolerability, and is thus very important.
The study is a prospective, randomized, single-blind and controlled clinical trial. Preterm children with a gestational age less than 34 weeks meeting the inclusion criteria who cannot be breastfed will be included. To demonstrate the application effect of extensively hydrolyzed milk protein formula on the target population, preterm children will be randomized into two groups, 185 subjects in each group. The observation group will be fed with extensively hydrolyzed milk protein (100 % whey protein) formula, while the control group will be fed with preterm children's formula until the children are discharged from the neonatal intensive care unit (NICU). All the formula involved in this study will be from Dumex. After discharge, both groups will be uniformly fed with formula for 0 to 6-month-old infants. For statistical analysis, a chi-square test and Student's t test will be applied using SAS 9.4.
This will be the first randomized controlled clinical study with long-term observation of the growth and development of preterm children during the NICU stay and at 3-month follow-up after discharge from the NICU. Results from this study will be used to determine whether the extensively hydrolyzed formula is more suitable for the low gastrointestinal tolerability of preterm children, and also whether feeding preterm children who are fed with such formula during the NICU stay with ordinary infant formula after discharge from the NICU would affect the normal growth and development of preterm children in the early stage of their lives.
This study was registered with the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/ ) with number ChiCTR-IOR-14005696 , on December 22, 2014.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>26537897</pmid><doi>10.1186/s13063-015-1030-5</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; PubMed Central Open Access; Springer Nature OA Free Journals; PubMed Central; SpringerLink Journals - AutoHoldings |
| subjects | Amino acids Bottle Feeding Breastfeeding & lactation Child Development China Clinical Protocols Clinical trials Enteral nutrition Fetuses Gestational Age Health aspects Humans Infant Infant Formula - administration & dosage Infant, Newborn Infant, Premature Infants (Premature) Influence Intensive Care Units, Neonatal Intensive Care, Neonatal Metabolism Milk proteins Milk Proteins - administration & dosage Milk Proteins - adverse effects Mortality Mothers Newborn babies Nosocomial infections Nutrition Nutritional Status Parenteral nutrition Pediatrics Peptides Premature birth Prospective Studies Protein Hydrolysates - administration & dosage Protein Hydrolysates - adverse effects Proteins Research Design Single-Blind Method Study Protocol Time Factors Treatment Outcome |
| title | Application effect of extensively hydrolyzed milk protein formula and follow-up in preterm children with a gestational age of less than 34 weeks: study protocol for a randomized controlled trial |
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