Randomized Trial of Early Developmental Intervention on Outcomes in Children after Birth Asphyxia in Developing Countries
Objective To determine if early developmental intervention (EDI) improves developmental abilities in resuscitated children. Study design This was a parallel group, randomized controlled trial of infants unresponsive to stimulation who received bag and mask ventilation as part of their resuscitation...
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| Veröffentlicht in: | The Journal of pediatrics 2013-04, Vol.162 (4), p.705-712.e3 |
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| creator | Carlo, Waldemar A., MD Goudar, Shivaprasad S., MD, MHPE Pasha, Omrana, MBBS, MSPH Chomba, Elwyn, MD Wallander, Jan L., PhD Biasini, Fred J., PhD McClure, Elizabeth M., MEd Thorsten, Vanessa, MPH Chakraborty, Hrishikesh, DrPH Wallace, Dennis, PhD Shearer, Darlene L., PhD Wright, Linda L., MD |
| description | Objective To determine if early developmental intervention (EDI) improves developmental abilities in resuscitated children. Study design This was a parallel group, randomized controlled trial of infants unresponsive to stimulation who received bag and mask ventilation as part of their resuscitation at birth and infants who did not require any resuscitation born in rural communities in India, Pakistan, and Zambia. Intervention infants received a parent-implemented EDI delivered with home visits by parent trainers every other week for 3 years starting the first month after birth. Parents in both intervention and control groups received health and safety counseling during home visits on the same schedule. The main outcome measure was the Mental Development Index (MDI) of the Bayley Scales of Infant Development, 2nd edition, assessed at 36 months by evaluators unaware of treatment group and resuscitation history. Results MDI was higher in the EDI (102.6 ± 9.8) compared with the control resuscitated children (98.0 ± 14.6, 1-sided P = .0202), but there was no difference between groups in the nonresuscitated children (100.1 ± 10.7 vs 97.7 ± 10.4, P = .1392). The Psychomotor Development Index was higher in the EDI group for both the resuscitated ( P = .0430) and nonresuscitated children ( P = .0164). Conclusions This trial of home-based, parent provided EDI in children resuscitated at birth provides evidence of treatment benefits on cognitive and psychomotor outcomes. MDI and Psychomotor Development Index scores of both nonresuscitated and resuscitated infants were within normal range, independent of early intervention. |
| doi_str_mv | 10.1016/j.jpeds.2012.09.052 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3582821</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0022347612011444</els_id><sourcerecordid>1320205431</sourcerecordid><originalsourceid>FETCH-LOGICAL-c538t-fff0f72c3377d64edb5bec37fb9f3b665436db8083d0178b3487fa79b0847e6d3</originalsourceid><addsrcrecordid>eNqFkl9v0zAUxSMEYt3gEyCBH3lJ8Z8kTh6YNLoBkyZNYtuz5djXrUNiFzupKJ8eh5YJeEGyZMv-neNrn5tlrwheEkyqd92y24KOS4oJXeJmiUv6JFsQ3PC8qhl7mi0wpjRnBa9OstMYO4xxU2D8PDuhjFQFI2SR7b9Ip_1gf4BG98HKHnmDrmTo9-gSdtD77QBuTNvXboSwS2vrHUrjdhqVHyAi69BqY3sdwCFpEoQ-2DBu0EXcbvbfrZyBo5V1a7TykxuDhfgie2ZkH-HlcT7LHj5e3a8-5ze3n65XFze5Klk95sYYbDhVjHGuqwJ0W7agGDdtY1hbVWXBKt3WuGYaE163rKi5kbxpcV1wqDQ7y84PvtupHUCr9IQge7ENdpBhL7y04u8TZzdi7XeClTWtKUkGb48GwX-bII5isFFB30sHfoqCMIopTnXMKDugKvgYA5jHawgWc2iiE79CE3NoAjcihZZUr_-s8FHzO6UEvDkARnoh18FG8XCXHMqUaM1T1ol4fyAg_eTOQhBRWXAKtA2gRqG9_U8J5__oVW-dVbL_CnuInZ-CSyEJImLSiLu5s-bGIsmEFEXBfgIdm8po</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1320205431</pqid></control><display><type>article</type><title>Randomized Trial of Early Developmental Intervention on Outcomes in Children after Birth Asphyxia in Developing Countries</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>Carlo, Waldemar A., MD ; Goudar, Shivaprasad S., MD, MHPE ; Pasha, Omrana, MBBS, MSPH ; Chomba, Elwyn, MD ; Wallander, Jan L., PhD ; Biasini, Fred J., PhD ; McClure, Elizabeth M., MEd ; Thorsten, Vanessa, MPH ; Chakraborty, Hrishikesh, DrPH ; Wallace, Dennis, PhD ; Shearer, Darlene L., PhD ; Wright, Linda L., MD</creator><creatorcontrib>Carlo, Waldemar A., MD ; Goudar, Shivaprasad S., MD, MHPE ; Pasha, Omrana, MBBS, MSPH ; Chomba, Elwyn, MD ; Wallander, Jan L., PhD ; Biasini, Fred J., PhD ; McClure, Elizabeth M., MEd ; Thorsten, Vanessa, MPH ; Chakraborty, Hrishikesh, DrPH ; Wallace, Dennis, PhD ; Shearer, Darlene L., PhD ; Wright, Linda L., MD ; Brain Research to Ameliorate Impaired Neurodevelopment-Home-Based Intervention Trial Committee and the National Institute of Child Health and Human Development Global Network for Women's and Children's Health Research Investigators</creatorcontrib><description>Objective To determine if early developmental intervention (EDI) improves developmental abilities in resuscitated children. Study design This was a parallel group, randomized controlled trial of infants unresponsive to stimulation who received bag and mask ventilation as part of their resuscitation at birth and infants who did not require any resuscitation born in rural communities in India, Pakistan, and Zambia. Intervention infants received a parent-implemented EDI delivered with home visits by parent trainers every other week for 3 years starting the first month after birth. Parents in both intervention and control groups received health and safety counseling during home visits on the same schedule. The main outcome measure was the Mental Development Index (MDI) of the Bayley Scales of Infant Development, 2nd edition, assessed at 36 months by evaluators unaware of treatment group and resuscitation history. Results MDI was higher in the EDI (102.6 ± 9.8) compared with the control resuscitated children (98.0 ± 14.6, 1-sided P = .0202), but there was no difference between groups in the nonresuscitated children (100.1 ± 10.7 vs 97.7 ± 10.4, P = .1392). The Psychomotor Development Index was higher in the EDI group for both the resuscitated ( P = .0430) and nonresuscitated children ( P = .0164). Conclusions This trial of home-based, parent provided EDI in children resuscitated at birth provides evidence of treatment benefits on cognitive and psychomotor outcomes. MDI and Psychomotor Development Index scores of both nonresuscitated and resuscitated infants were within normal range, independent of early intervention.</description><identifier>ISSN: 0022-3476</identifier><identifier>EISSN: 1097-6833</identifier><identifier>DOI: 10.1016/j.jpeds.2012.09.052</identifier><identifier>PMID: 23164311</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>asphyxia ; Asphyxia - therapy ; Child Development ; children ; cognition ; Cognition Disorders - prevention & control ; counseling ; Developing Countries ; Developmental Disabilities - diagnosis ; Early Intervention (Education) - methods ; Female ; Humans ; India ; infant development ; Infant, Newborn ; infants ; Male ; Pakistan ; parents ; Pediatrics ; psychomotor development ; Psychomotor Disorders - prevention & control ; randomized clinical trials ; Resuscitation ; rural communities ; Rural Population ; Surveys and Questionnaires ; Treatment Outcome ; Zambia</subject><ispartof>The Journal of pediatrics, 2013-04, Vol.162 (4), p.705-712.e3</ispartof><rights>Mosby, Inc.</rights><rights>2013 Mosby, Inc.</rights><rights>Copyright © 2013 Mosby, Inc. All rights reserved.</rights><rights>2012 Mosby, Inc. All rights reserved. 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c538t-fff0f72c3377d64edb5bec37fb9f3b665436db8083d0178b3487fa79b0847e6d3</citedby><cites>FETCH-LOGICAL-c538t-fff0f72c3377d64edb5bec37fb9f3b665436db8083d0178b3487fa79b0847e6d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0022347612011444$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23164311$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Carlo, Waldemar A., MD</creatorcontrib><creatorcontrib>Goudar, Shivaprasad S., MD, MHPE</creatorcontrib><creatorcontrib>Pasha, Omrana, MBBS, MSPH</creatorcontrib><creatorcontrib>Chomba, Elwyn, MD</creatorcontrib><creatorcontrib>Wallander, Jan L., PhD</creatorcontrib><creatorcontrib>Biasini, Fred J., PhD</creatorcontrib><creatorcontrib>McClure, Elizabeth M., MEd</creatorcontrib><creatorcontrib>Thorsten, Vanessa, MPH</creatorcontrib><creatorcontrib>Chakraborty, Hrishikesh, DrPH</creatorcontrib><creatorcontrib>Wallace, Dennis, PhD</creatorcontrib><creatorcontrib>Shearer, Darlene L., PhD</creatorcontrib><creatorcontrib>Wright, Linda L., MD</creatorcontrib><creatorcontrib>Brain Research to Ameliorate Impaired Neurodevelopment-Home-Based Intervention Trial Committee and the National Institute of Child Health and Human Development Global Network for Women's and Children's Health Research Investigators</creatorcontrib><title>Randomized Trial of Early Developmental Intervention on Outcomes in Children after Birth Asphyxia in Developing Countries</title><title>The Journal of pediatrics</title><addtitle>J Pediatr</addtitle><description>Objective To determine if early developmental intervention (EDI) improves developmental abilities in resuscitated children. Study design This was a parallel group, randomized controlled trial of infants unresponsive to stimulation who received bag and mask ventilation as part of their resuscitation at birth and infants who did not require any resuscitation born in rural communities in India, Pakistan, and Zambia. Intervention infants received a parent-implemented EDI delivered with home visits by parent trainers every other week for 3 years starting the first month after birth. Parents in both intervention and control groups received health and safety counseling during home visits on the same schedule. The main outcome measure was the Mental Development Index (MDI) of the Bayley Scales of Infant Development, 2nd edition, assessed at 36 months by evaluators unaware of treatment group and resuscitation history. Results MDI was higher in the EDI (102.6 ± 9.8) compared with the control resuscitated children (98.0 ± 14.6, 1-sided P = .0202), but there was no difference between groups in the nonresuscitated children (100.1 ± 10.7 vs 97.7 ± 10.4, P = .1392). The Psychomotor Development Index was higher in the EDI group for both the resuscitated ( P = .0430) and nonresuscitated children ( P = .0164). Conclusions This trial of home-based, parent provided EDI in children resuscitated at birth provides evidence of treatment benefits on cognitive and psychomotor outcomes. MDI and Psychomotor Development Index scores of both nonresuscitated and resuscitated infants were within normal range, independent of early intervention.</description><subject>asphyxia</subject><subject>Asphyxia - therapy</subject><subject>Child Development</subject><subject>children</subject><subject>cognition</subject><subject>Cognition Disorders - prevention & control</subject><subject>counseling</subject><subject>Developing Countries</subject><subject>Developmental Disabilities - diagnosis</subject><subject>Early Intervention (Education) - methods</subject><subject>Female</subject><subject>Humans</subject><subject>India</subject><subject>infant development</subject><subject>Infant, Newborn</subject><subject>infants</subject><subject>Male</subject><subject>Pakistan</subject><subject>parents</subject><subject>Pediatrics</subject><subject>psychomotor development</subject><subject>Psychomotor Disorders - prevention & control</subject><subject>randomized clinical trials</subject><subject>Resuscitation</subject><subject>rural communities</subject><subject>Rural Population</subject><subject>Surveys and Questionnaires</subject><subject>Treatment Outcome</subject><subject>Zambia</subject><issn>0022-3476</issn><issn>1097-6833</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkl9v0zAUxSMEYt3gEyCBH3lJ8Z8kTh6YNLoBkyZNYtuz5djXrUNiFzupKJ8eh5YJeEGyZMv-neNrn5tlrwheEkyqd92y24KOS4oJXeJmiUv6JFsQ3PC8qhl7mi0wpjRnBa9OstMYO4xxU2D8PDuhjFQFI2SR7b9Ip_1gf4BG98HKHnmDrmTo9-gSdtD77QBuTNvXboSwS2vrHUrjdhqVHyAi69BqY3sdwCFpEoQ-2DBu0EXcbvbfrZyBo5V1a7TykxuDhfgie2ZkH-HlcT7LHj5e3a8-5ze3n65XFze5Klk95sYYbDhVjHGuqwJ0W7agGDdtY1hbVWXBKt3WuGYaE163rKi5kbxpcV1wqDQ7y84PvtupHUCr9IQge7ENdpBhL7y04u8TZzdi7XeClTWtKUkGb48GwX-bII5isFFB30sHfoqCMIopTnXMKDugKvgYA5jHawgWc2iiE79CE3NoAjcihZZUr_-s8FHzO6UEvDkARnoh18FG8XCXHMqUaM1T1ol4fyAg_eTOQhBRWXAKtA2gRqG9_U8J5__oVW-dVbL_CnuInZ-CSyEJImLSiLu5s-bGIsmEFEXBfgIdm8po</recordid><startdate>20130401</startdate><enddate>20130401</enddate><creator>Carlo, Waldemar A., MD</creator><creator>Goudar, Shivaprasad S., MD, MHPE</creator><creator>Pasha, Omrana, MBBS, MSPH</creator><creator>Chomba, Elwyn, MD</creator><creator>Wallander, Jan L., PhD</creator><creator>Biasini, Fred J., PhD</creator><creator>McClure, Elizabeth M., MEd</creator><creator>Thorsten, Vanessa, MPH</creator><creator>Chakraborty, Hrishikesh, DrPH</creator><creator>Wallace, Dennis, PhD</creator><creator>Shearer, Darlene L., PhD</creator><creator>Wright, Linda L., MD</creator><general>Elsevier Inc</general><general>Mosby, Inc</general><scope>FBQ</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><scope>5PM</scope></search><sort><creationdate>20130401</creationdate><title>Randomized Trial of Early Developmental Intervention on Outcomes in Children after Birth Asphyxia in Developing Countries</title><author>Carlo, Waldemar A., MD ; Goudar, Shivaprasad S., MD, MHPE ; Pasha, Omrana, MBBS, MSPH ; Chomba, Elwyn, MD ; Wallander, Jan L., PhD ; Biasini, Fred J., PhD ; McClure, Elizabeth M., MEd ; Thorsten, Vanessa, MPH ; Chakraborty, Hrishikesh, DrPH ; Wallace, Dennis, PhD ; Shearer, Darlene L., PhD ; Wright, Linda L., MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c538t-fff0f72c3377d64edb5bec37fb9f3b665436db8083d0178b3487fa79b0847e6d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>asphyxia</topic><topic>Asphyxia - therapy</topic><topic>Child Development</topic><topic>children</topic><topic>cognition</topic><topic>Cognition Disorders - prevention & control</topic><topic>counseling</topic><topic>Developing Countries</topic><topic>Developmental Disabilities - diagnosis</topic><topic>Early Intervention (Education) - methods</topic><topic>Female</topic><topic>Humans</topic><topic>India</topic><topic>infant development</topic><topic>Infant, Newborn</topic><topic>infants</topic><topic>Male</topic><topic>Pakistan</topic><topic>parents</topic><topic>Pediatrics</topic><topic>psychomotor development</topic><topic>Psychomotor Disorders - prevention & control</topic><topic>randomized clinical trials</topic><topic>Resuscitation</topic><topic>rural communities</topic><topic>Rural Population</topic><topic>Surveys and Questionnaires</topic><topic>Treatment Outcome</topic><topic>Zambia</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Carlo, Waldemar A., MD</creatorcontrib><creatorcontrib>Goudar, Shivaprasad S., MD, MHPE</creatorcontrib><creatorcontrib>Pasha, Omrana, MBBS, MSPH</creatorcontrib><creatorcontrib>Chomba, Elwyn, MD</creatorcontrib><creatorcontrib>Wallander, Jan L., PhD</creatorcontrib><creatorcontrib>Biasini, Fred J., PhD</creatorcontrib><creatorcontrib>McClure, Elizabeth M., MEd</creatorcontrib><creatorcontrib>Thorsten, Vanessa, MPH</creatorcontrib><creatorcontrib>Chakraborty, Hrishikesh, DrPH</creatorcontrib><creatorcontrib>Wallace, Dennis, PhD</creatorcontrib><creatorcontrib>Shearer, Darlene L., PhD</creatorcontrib><creatorcontrib>Wright, Linda L., MD</creatorcontrib><creatorcontrib>Brain Research to Ameliorate Impaired Neurodevelopment-Home-Based Intervention Trial Committee and the National Institute of Child Health and Human Development Global Network for Women's and Children's Health Research Investigators</creatorcontrib><collection>AGRIS</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><collection>PubMed Central (Full Participant titles)</collection><jtitle>The Journal of pediatrics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Carlo, Waldemar A., MD</au><au>Goudar, Shivaprasad S., MD, MHPE</au><au>Pasha, Omrana, MBBS, MSPH</au><au>Chomba, Elwyn, MD</au><au>Wallander, Jan L., PhD</au><au>Biasini, Fred J., PhD</au><au>McClure, Elizabeth M., MEd</au><au>Thorsten, Vanessa, MPH</au><au>Chakraborty, Hrishikesh, DrPH</au><au>Wallace, Dennis, PhD</au><au>Shearer, Darlene L., PhD</au><au>Wright, Linda L., MD</au><aucorp>Brain Research to Ameliorate Impaired Neurodevelopment-Home-Based Intervention Trial Committee and the National Institute of Child Health and Human Development Global Network for Women's and Children's Health Research Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized Trial of Early Developmental Intervention on Outcomes in Children after Birth Asphyxia in Developing Countries</atitle><jtitle>The Journal of pediatrics</jtitle><addtitle>J Pediatr</addtitle><date>2013-04-01</date><risdate>2013</risdate><volume>162</volume><issue>4</issue><spage>705</spage><epage>712.e3</epage><pages>705-712.e3</pages><issn>0022-3476</issn><eissn>1097-6833</eissn><abstract>Objective To determine if early developmental intervention (EDI) improves developmental abilities in resuscitated children. Study design This was a parallel group, randomized controlled trial of infants unresponsive to stimulation who received bag and mask ventilation as part of their resuscitation at birth and infants who did not require any resuscitation born in rural communities in India, Pakistan, and Zambia. Intervention infants received a parent-implemented EDI delivered with home visits by parent trainers every other week for 3 years starting the first month after birth. Parents in both intervention and control groups received health and safety counseling during home visits on the same schedule. The main outcome measure was the Mental Development Index (MDI) of the Bayley Scales of Infant Development, 2nd edition, assessed at 36 months by evaluators unaware of treatment group and resuscitation history. Results MDI was higher in the EDI (102.6 ± 9.8) compared with the control resuscitated children (98.0 ± 14.6, 1-sided P = .0202), but there was no difference between groups in the nonresuscitated children (100.1 ± 10.7 vs 97.7 ± 10.4, P = .1392). The Psychomotor Development Index was higher in the EDI group for both the resuscitated ( P = .0430) and nonresuscitated children ( P = .0164). Conclusions This trial of home-based, parent provided EDI in children resuscitated at birth provides evidence of treatment benefits on cognitive and psychomotor outcomes. MDI and Psychomotor Development Index scores of both nonresuscitated and resuscitated infants were within normal range, independent of early intervention.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>23164311</pmid><doi>10.1016/j.jpeds.2012.09.052</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | The Journal of pediatrics, 2013-04, Vol.162 (4), p.705-712.e3 |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | asphyxia Asphyxia - therapy Child Development children cognition Cognition Disorders - prevention & control counseling Developing Countries Developmental Disabilities - diagnosis Early Intervention (Education) - methods Female Humans India infant development Infant, Newborn infants Male Pakistan parents Pediatrics psychomotor development Psychomotor Disorders - prevention & control randomized clinical trials Resuscitation rural communities Rural Population Surveys and Questionnaires Treatment Outcome Zambia |
| title | Randomized Trial of Early Developmental Intervention on Outcomes in Children after Birth Asphyxia in Developing Countries |
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