Community initiated kangaroo mother care and early child development in low birth weight infants in India-a randomized controlled trial
Abstract Background In a randomized controlled trial (RCT) with 8402 stable low birthweight (LBW) infants, majority being late preterm or term small for gestational age, community-initiated KMC (ciKMC) showed a significant improvement in survival. However, the effect of ciKMC on neurodevelopment is...
| Main Authors: | , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2020-04-01
|
| Series: | BMC Pediatrics |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12887-020-02046-4 |
| _version_ | 1818993599182798848 |
|---|---|
| author | Sunita Taneja Bireshwar Sinha Ravi Prakash Upadhyay Sarmila Mazumder Halvor Sommerfelt Jose Martines Suresh Kumar Dalpath Rakesh Gupta Patricia Kariger Rajiv Bahl Nita Bhandari Tarun Dua for the ciKMC development study group |
| author_facet | Sunita Taneja Bireshwar Sinha Ravi Prakash Upadhyay Sarmila Mazumder Halvor Sommerfelt Jose Martines Suresh Kumar Dalpath Rakesh Gupta Patricia Kariger Rajiv Bahl Nita Bhandari Tarun Dua for the ciKMC development study group |
| author_sort | Sunita Taneja |
| collection | DOAJ |
| description | Abstract Background In a randomized controlled trial (RCT) with 8402 stable low birthweight (LBW) infants, majority being late preterm or term small for gestational age, community-initiated KMC (ciKMC) showed a significant improvement in survival. However, the effect of ciKMC on neurodevelopment is unclear. This is important to elucidate as children born with low birth weight are at high risk of neurodevelopmental deficits. In the first 552 stable LBW infants enrolled in the above trial, we evaluated the effect of ciKMC on neurodevelopmental outcomes during infancy. Method This RCT was conducted among 552 stable LBW infants, majorly late preterm or term small for gestational age infants without any problems at birth and weighing 1500–2250 g at birth. The intervention comprised of promotion of skin-to-skin contact and exclusive breastfeeding by trained intervention delivery team through home visits. The intervention group mother-infant-dyads were supported to practice ciKMC till day 28 after birth or until the baby wriggled-out. All infants in the intervention and control groups received Home Based Post Natal Care (HBPNC) visits by government health workers. Cognitive, language, motor and socio-emotional outcomes were assessed at infant-ages 6- and 12-months using Bayley Scale of Infant Development (BSID-III). Other outcomes measured were infant temperament, maternal depression, maternal sense of competence, mother-infant bonding and home-environment. We performed post-hoc equivalence testing using two one-sided tests of equivalence (TOST) to provide evidence that ciKMC does not do harm in terms of neurodevelopment. Results In the intervention arm, the median (IQR) time to initiate ciKMC was 48 (48 to 72) hours after birth. The mean (SD) duration of skin-to-skin-contact was 27.9 (3.9) days with a mean (SD) of 8.7 (3.5) hours per day. We did not find significant effect of ciKMC on any of the child developmental outcomes during infancy. The TOST analysis demonstrated that composite scores for cognitive, language and motor domains at 12 months among the study arms were statistically equivalent. Conclusion Our study was unable to capture any effect of ciKMC on neurodevelopment during infancy in this sample of stable late preterm or term small for gestational age infants. Long term follow-up may provide meaningful insights. Trial registration The trial is registered at clinicaltrials.gov NCT02631343 dated February 17, 2016; Retrospectively registered. |
| first_indexed | 2024-12-20T20:44:37Z |
| format | Article |
| id | doaj.art-38679d8ed82243ba8616be42c88a776a |
| institution | Directory Open Access Journal |
| issn | 1471-2431 |
| language | English |
| last_indexed | 2024-12-20T20:44:37Z |
| publishDate | 2020-04-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pediatrics |
| spelling | doaj.art-38679d8ed82243ba8616be42c88a776a2022-12-21T19:27:04ZengBMCBMC Pediatrics1471-24312020-04-0120111210.1186/s12887-020-02046-4Community initiated kangaroo mother care and early child development in low birth weight infants in India-a randomized controlled trialSunita Taneja0Bireshwar Sinha1Ravi Prakash Upadhyay2Sarmila Mazumder3Halvor Sommerfelt4Jose Martines5Suresh Kumar Dalpath6Rakesh Gupta7Patricia Kariger8Rajiv Bahl9Nita Bhandari10Tarun Dua11for the ciKMC development study groupCentre for Health Research and Development, Society for Applied StudiesCentre for Health Research and Development, Society for Applied StudiesCentre for Health Research and Development, Society for Applied StudiesCentre for Health Research and Development, Society for Applied StudiesCentre for Intervention Science in Maternal and Child Health, Department of Global Public Health and Primary Care, University of BergenCentre for Intervention Science in Maternal and Child Health, Department of Global Public Health and Primary Care, University of BergenState Health System Resource CentreDepartment of School Education, Government of HaryanaCenter for Effective Global Health, University of CaliforniaDepartment of Maternal, Newborn, Child and Adolescent Health, World Health OrganizationCentre for Health Research and Development, Society for Applied StudiesDepartment of Mental Health and Substance Abuse, World Health OrganizationAbstract Background In a randomized controlled trial (RCT) with 8402 stable low birthweight (LBW) infants, majority being late preterm or term small for gestational age, community-initiated KMC (ciKMC) showed a significant improvement in survival. However, the effect of ciKMC on neurodevelopment is unclear. This is important to elucidate as children born with low birth weight are at high risk of neurodevelopmental deficits. In the first 552 stable LBW infants enrolled in the above trial, we evaluated the effect of ciKMC on neurodevelopmental outcomes during infancy. Method This RCT was conducted among 552 stable LBW infants, majorly late preterm or term small for gestational age infants without any problems at birth and weighing 1500–2250 g at birth. The intervention comprised of promotion of skin-to-skin contact and exclusive breastfeeding by trained intervention delivery team through home visits. The intervention group mother-infant-dyads were supported to practice ciKMC till day 28 after birth or until the baby wriggled-out. All infants in the intervention and control groups received Home Based Post Natal Care (HBPNC) visits by government health workers. Cognitive, language, motor and socio-emotional outcomes were assessed at infant-ages 6- and 12-months using Bayley Scale of Infant Development (BSID-III). Other outcomes measured were infant temperament, maternal depression, maternal sense of competence, mother-infant bonding and home-environment. We performed post-hoc equivalence testing using two one-sided tests of equivalence (TOST) to provide evidence that ciKMC does not do harm in terms of neurodevelopment. Results In the intervention arm, the median (IQR) time to initiate ciKMC was 48 (48 to 72) hours after birth. The mean (SD) duration of skin-to-skin-contact was 27.9 (3.9) days with a mean (SD) of 8.7 (3.5) hours per day. We did not find significant effect of ciKMC on any of the child developmental outcomes during infancy. The TOST analysis demonstrated that composite scores for cognitive, language and motor domains at 12 months among the study arms were statistically equivalent. Conclusion Our study was unable to capture any effect of ciKMC on neurodevelopment during infancy in this sample of stable late preterm or term small for gestational age infants. Long term follow-up may provide meaningful insights. Trial registration The trial is registered at clinicaltrials.gov NCT02631343 dated February 17, 2016; Retrospectively registered.http://link.springer.com/article/10.1186/s12887-020-02046-4Child developmentKangaroo mother careLow birth weight, community initiated |
| spellingShingle | Sunita Taneja Bireshwar Sinha Ravi Prakash Upadhyay Sarmila Mazumder Halvor Sommerfelt Jose Martines Suresh Kumar Dalpath Rakesh Gupta Patricia Kariger Rajiv Bahl Nita Bhandari Tarun Dua for the ciKMC development study group Community initiated kangaroo mother care and early child development in low birth weight infants in India-a randomized controlled trial BMC Pediatrics Child development Kangaroo mother care Low birth weight, community initiated |
| title | Community initiated kangaroo mother care and early child development in low birth weight infants in India-a randomized controlled trial |
| title_full | Community initiated kangaroo mother care and early child development in low birth weight infants in India-a randomized controlled trial |
| title_fullStr | Community initiated kangaroo mother care and early child development in low birth weight infants in India-a randomized controlled trial |
| title_full_unstemmed | Community initiated kangaroo mother care and early child development in low birth weight infants in India-a randomized controlled trial |
| title_short | Community initiated kangaroo mother care and early child development in low birth weight infants in India-a randomized controlled trial |
| title_sort | community initiated kangaroo mother care and early child development in low birth weight infants in india a randomized controlled trial |
| topic | Child development Kangaroo mother care Low birth weight, community initiated |
| url | http://link.springer.com/article/10.1186/s12887-020-02046-4 |
| work_keys_str_mv | AT sunitataneja communityinitiatedkangaroomothercareandearlychilddevelopmentinlowbirthweightinfantsinindiaarandomizedcontrolledtrial AT bireshwarsinha communityinitiatedkangaroomothercareandearlychilddevelopmentinlowbirthweightinfantsinindiaarandomizedcontrolledtrial AT raviprakashupadhyay communityinitiatedkangaroomothercareandearlychilddevelopmentinlowbirthweightinfantsinindiaarandomizedcontrolledtrial AT sarmilamazumder communityinitiatedkangaroomothercareandearlychilddevelopmentinlowbirthweightinfantsinindiaarandomizedcontrolledtrial AT halvorsommerfelt communityinitiatedkangaroomothercareandearlychilddevelopmentinlowbirthweightinfantsinindiaarandomizedcontrolledtrial AT josemartines communityinitiatedkangaroomothercareandearlychilddevelopmentinlowbirthweightinfantsinindiaarandomizedcontrolledtrial AT sureshkumardalpath communityinitiatedkangaroomothercareandearlychilddevelopmentinlowbirthweightinfantsinindiaarandomizedcontrolledtrial AT rakeshgupta communityinitiatedkangaroomothercareandearlychilddevelopmentinlowbirthweightinfantsinindiaarandomizedcontrolledtrial AT patriciakariger communityinitiatedkangaroomothercareandearlychilddevelopmentinlowbirthweightinfantsinindiaarandomizedcontrolledtrial AT rajivbahl communityinitiatedkangaroomothercareandearlychilddevelopmentinlowbirthweightinfantsinindiaarandomizedcontrolledtrial AT nitabhandari communityinitiatedkangaroomothercareandearlychilddevelopmentinlowbirthweightinfantsinindiaarandomizedcontrolledtrial AT tarundua communityinitiatedkangaroomothercareandearlychilddevelopmentinlowbirthweightinfantsinindiaarandomizedcontrolledtrial AT forthecikmcdevelopmentstudygroup communityinitiatedkangaroomothercareandearlychilddevelopmentinlowbirthweightinfantsinindiaarandomizedcontrolledtrial |