Evaluation of the impact of continuous Kangaroo Mother Care (KMC) initiated immediately after birth compared to KMC initiated after stabilization in newborns with birth weight 1.0 to < 1.8 kg on neurodevelopmental outcomes: Protocol for a follow-up study
Abstract Background Preterm birth or low birth weight is the single largest cause of death in newborns, however this mortality can be reduced through newborn care interventions, including Kangaroo Mother Care (KMC). Previously, a multi-country randomized controlled trial, coordinated by the World He...
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BMC
2023-04-01
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| Online Access: | https://doi.org/10.1186/s13063-023-07192-5 |
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| author | E. A. Adejuyigbe I. Agyeman P. Anand H. C. Anyabolu S. Arya E. N. Assenga S. Badhal N. W. Brobby H. K. Chellani N. Chopra P. K. Debata Q. Dube T. Dua L. Gadama R. Gera C. K. Hammond S. Jain F. Kantumbiza K. Kawaza E. N. Kija P. Lal M. Mallewa M. K. Manu A. Mehta T. Mhango H. E. Naburi S. Newton I. Nyanor P. A. Nyako O. J. Oke A. Patel G. Phlange-Rhule R. Sehgal R. Singhal N. Wadhwa A. B. Yiadom |
| author_facet | E. A. Adejuyigbe I. Agyeman P. Anand H. C. Anyabolu S. Arya E. N. Assenga S. Badhal N. W. Brobby H. K. Chellani N. Chopra P. K. Debata Q. Dube T. Dua L. Gadama R. Gera C. K. Hammond S. Jain F. Kantumbiza K. Kawaza E. N. Kija P. Lal M. Mallewa M. K. Manu A. Mehta T. Mhango H. E. Naburi S. Newton I. Nyanor P. A. Nyako O. J. Oke A. Patel G. Phlange-Rhule R. Sehgal R. Singhal N. Wadhwa A. B. Yiadom |
| author_sort | E. A. Adejuyigbe |
| collection | DOAJ |
| description | Abstract Background Preterm birth or low birth weight is the single largest cause of death in newborns, however this mortality can be reduced through newborn care interventions, including Kangaroo Mother Care (KMC). Previously, a multi-country randomized controlled trial, coordinated by the World Health Organization (WHO), reported a significant survival advantage with initiation of continuous KMC immediately after birth compared with initiation of continuous KMC a few days after birth when the baby is considered clinically stable. Whether the survival advantage would lead to higher rates of neurodevelopmental morbidities, or the immediate KMC will also have a beneficial effect on cognitive development also, has not been investigated. We therefore propose to test the hypothesis that low-birth-weight infants exposed to immediate KMC will have lower rates of neurodevelopmental impairment in comparison to traditional KMC-treated infants, by prospectively following up infants already enrolled in the immediate KMC trial for the first 2 years of life, and assessing their growth and neurodevelopment. Methods This prospective cohort study will enroll surviving neonates from the main WHO immediate KMC trial. The main trial as well as this follow-up study are being conducted in five low- and middle-income countries in South Asia and sub-Saharan Africa. The estimated sample size for comparison of the risk of neurodevelopmental impairment is a total of 2200 children. The primary outcome will include rates of cerebral palsy, hearing impairment, vision impairment, mental and motor development, and epilepsy and will be assessed by the age of 3 years. The analysis will be by intention to treat. Discussion Immediate KMC can potentially reduce low-birth-weight-associated complications such as respiratory disease, hypothermia, hypoglycemia, and infection that can result in impaired neurocognitive development. Neuroprotection may also be mediated by improved physiological stabilization that may lead to better maturation of neural pathways, reduced risk of hypoxia, positive parental impact, improved sleep cycles, and improved stress responses. The present study will help in evaluating the overall impact of KMC by investigating the long-term effect on neurodevelopmental impairment in the survivors. Trial registration Clinical Trials Registry-India CTRI/2019/11/021899. Registered on 06 November 2019. Trials registration of parent trial: ACTRN12618001880235; Clinical Trials Registry-India: CTRI/2018/08/015369. |
| first_indexed | 2024-04-09T17:45:04Z |
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| id | doaj.art-7379ecb32fad4b3a98c14c40e4febfe2 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-09T17:45:04Z |
| publishDate | 2023-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-7379ecb32fad4b3a98c14c40e4febfe22023-04-16T11:24:21ZengBMCTrials1745-62152023-04-0124111310.1186/s13063-023-07192-5Evaluation of the impact of continuous Kangaroo Mother Care (KMC) initiated immediately after birth compared to KMC initiated after stabilization in newborns with birth weight 1.0 to < 1.8 kg on neurodevelopmental outcomes: Protocol for a follow-up studyE. A. Adejuyigbe0I. Agyeman1P. Anand2H. C. Anyabolu3S. Arya4E. N. Assenga5S. Badhal6N. W. Brobby7H. K. Chellani8N. Chopra9P. K. Debata10Q. Dube11T. Dua12L. Gadama13R. Gera14C. K. Hammond15S. Jain16F. Kantumbiza17K. Kawaza18E. N. Kija19P. Lal20M. Mallewa21M. K. Manu22A. Mehta23T. Mhango24H. E. Naburi25S. Newton26I. Nyanor27P. A. Nyako28O. J. Oke29A. Patel30G. Phlange-Rhule31R. Sehgal32R. Singhal33N. Wadhwa34A. B. Yiadom35Department of Paediatrics and Child Health, Obafemi Awolowo UniversityKomfo Anokye Teaching HospitalDepartment of Pediatrics, Vardhman Mahavir Medical College and Safdarjung HospitalDepartment of Paediatrics and Child Health, Obafemi Awolowo UniversityDepartment of Pediatrics, Vardhman Mahavir Medical College and Safdarjung HospitalDepartment of Paediatrics and Child Health, School of Medicine, Muhimbili University of Health and Allied SciencesVardhman Mahavir Medical College and Safdarjung HospitalDepartment of Child Health, Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and TechnologyDepartment of Pediatrics, Vardhman Mahavir Medical College and Safdarjung HospitalDepartment of Pediatrics, Vardhman Mahavir Medical College and Safdarjung HospitalDepartment of Pediatrics, Vardhman Mahavir Medical College and Safdarjung HospitalQueen Elizabeth Central HospitalDepartment of Mental Health and Substance Use, World Health OrganizationDepartment of Obstetrics and Gynaecology, Kamuzu University of Health SciencesDepartment of Pediatrics, Vardhman Mahavir Medical College and Safdarjung HospitalDepartment of Child Health, Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and TechnologyVardhman Mahavir Medical College and Safdarjung HospitalDepartment of Paediatrics and Child Health, Kamuzu University of Health SciencesDepartment of Paediatrics and Child Health, Kamuzu University of Health SciencesDepartment of Paediatrics and Child Health, School of Medicine, Muhimbili University of Health and Allied SciencesAtal Bihari Vajpayee Institute of Medical Sciences &, Dr Ram Manohar Lohia HospitalDepartment of Paediatrics and Child Health, Kamuzu University of Health SciencesKomfo Anokye Teaching HospitalVardhman Mahavir Medical College and Safdarjung HospitalDepartment of Paediatrics and Child Health, Kamuzu University of Health SciencesDepartment of Paediatrics and Child Health, School of Medicine, Muhimbili University of Health and Allied SciencesSchool of Public Health, Kwame Nkrumah University of Science and TechnologyResearch and Development, Komfo Anokye Teaching HospitalDepartment of Psychiatry, Child And Adolescent Mental Health, Komfo Anokye Teaching HospitalDepartment of Paediatrics and Child Health, Obafemi Awolowo UniversityDepartment of Mental Health and Substance Use, World Health OrganizationClinical Development Services Agency (CDSA), Translational Health Science and Technology Institute (THSTI), NCR Biotech Science ClusterDepartment of Pediatrics, Vardhman Mahavir Medical College and Safdarjung HospitalTranslational Health Science and Technology Institute (THSTI), NCR Biotech Science ClusterFaridabad-Gurgaon Expressway, Translational Health Science and Technology Institute, NCR Biotech Science ClusterDepartment of Child Health, Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and TechnologyAbstract Background Preterm birth or low birth weight is the single largest cause of death in newborns, however this mortality can be reduced through newborn care interventions, including Kangaroo Mother Care (KMC). Previously, a multi-country randomized controlled trial, coordinated by the World Health Organization (WHO), reported a significant survival advantage with initiation of continuous KMC immediately after birth compared with initiation of continuous KMC a few days after birth when the baby is considered clinically stable. Whether the survival advantage would lead to higher rates of neurodevelopmental morbidities, or the immediate KMC will also have a beneficial effect on cognitive development also, has not been investigated. We therefore propose to test the hypothesis that low-birth-weight infants exposed to immediate KMC will have lower rates of neurodevelopmental impairment in comparison to traditional KMC-treated infants, by prospectively following up infants already enrolled in the immediate KMC trial for the first 2 years of life, and assessing their growth and neurodevelopment. Methods This prospective cohort study will enroll surviving neonates from the main WHO immediate KMC trial. The main trial as well as this follow-up study are being conducted in five low- and middle-income countries in South Asia and sub-Saharan Africa. The estimated sample size for comparison of the risk of neurodevelopmental impairment is a total of 2200 children. The primary outcome will include rates of cerebral palsy, hearing impairment, vision impairment, mental and motor development, and epilepsy and will be assessed by the age of 3 years. The analysis will be by intention to treat. Discussion Immediate KMC can potentially reduce low-birth-weight-associated complications such as respiratory disease, hypothermia, hypoglycemia, and infection that can result in impaired neurocognitive development. Neuroprotection may also be mediated by improved physiological stabilization that may lead to better maturation of neural pathways, reduced risk of hypoxia, positive parental impact, improved sleep cycles, and improved stress responses. The present study will help in evaluating the overall impact of KMC by investigating the long-term effect on neurodevelopmental impairment in the survivors. Trial registration Clinical Trials Registry-India CTRI/2019/11/021899. Registered on 06 November 2019. Trials registration of parent trial: ACTRN12618001880235; Clinical Trials Registry-India: CTRI/2018/08/015369.https://doi.org/10.1186/s13063-023-07192-5Immediate Kangaroo Mother Care (iKMC)Low-birth-weight babiesNeurodevelopmentLow- and middle-income countries |
| spellingShingle | E. A. Adejuyigbe I. Agyeman P. Anand H. C. Anyabolu S. Arya E. N. Assenga S. Badhal N. W. Brobby H. K. Chellani N. Chopra P. K. Debata Q. Dube T. Dua L. Gadama R. Gera C. K. Hammond S. Jain F. Kantumbiza K. Kawaza E. N. Kija P. Lal M. Mallewa M. K. Manu A. Mehta T. Mhango H. E. Naburi S. Newton I. Nyanor P. A. Nyako O. J. Oke A. Patel G. Phlange-Rhule R. Sehgal R. Singhal N. Wadhwa A. B. Yiadom Evaluation of the impact of continuous Kangaroo Mother Care (KMC) initiated immediately after birth compared to KMC initiated after stabilization in newborns with birth weight 1.0 to < 1.8 kg on neurodevelopmental outcomes: Protocol for a follow-up study Trials Immediate Kangaroo Mother Care (iKMC) Low-birth-weight babies Neurodevelopment Low- and middle-income countries |
| title | Evaluation of the impact of continuous Kangaroo Mother Care (KMC) initiated immediately after birth compared to KMC initiated after stabilization in newborns with birth weight 1.0 to < 1.8 kg on neurodevelopmental outcomes: Protocol for a follow-up study |
| title_full | Evaluation of the impact of continuous Kangaroo Mother Care (KMC) initiated immediately after birth compared to KMC initiated after stabilization in newborns with birth weight 1.0 to < 1.8 kg on neurodevelopmental outcomes: Protocol for a follow-up study |
| title_fullStr | Evaluation of the impact of continuous Kangaroo Mother Care (KMC) initiated immediately after birth compared to KMC initiated after stabilization in newborns with birth weight 1.0 to < 1.8 kg on neurodevelopmental outcomes: Protocol for a follow-up study |
| title_full_unstemmed | Evaluation of the impact of continuous Kangaroo Mother Care (KMC) initiated immediately after birth compared to KMC initiated after stabilization in newborns with birth weight 1.0 to < 1.8 kg on neurodevelopmental outcomes: Protocol for a follow-up study |
| title_short | Evaluation of the impact of continuous Kangaroo Mother Care (KMC) initiated immediately after birth compared to KMC initiated after stabilization in newborns with birth weight 1.0 to < 1.8 kg on neurodevelopmental outcomes: Protocol for a follow-up study |
| title_sort | evaluation of the impact of continuous kangaroo mother care kmc initiated immediately after birth compared to kmc initiated after stabilization in newborns with birth weight 1 0 to 1 8 kg on neurodevelopmental outcomes protocol for a follow up study |
| topic | Immediate Kangaroo Mother Care (iKMC) Low-birth-weight babies Neurodevelopment Low- and middle-income countries |
| url | https://doi.org/10.1186/s13063-023-07192-5 |
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