دورية أكاديمية
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.
| العنوان: | 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. |
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| المؤلفون: | Adejuyigbe EA; Department of Paediatrics and Child Health, Obafemi Awolowo University, Ile-Ife, 220005, Nigeria., Agyeman I; Komfo Anokye Teaching Hospital, P.O. Box 1934, Adum, Kumasi, Ghana., Anand P; Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India., Anyabolu HC; Department of Paediatrics and Child Health, Obafemi Awolowo University, Ile-Ife, 220005, Nigeria., Arya S; Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India., Assenga EN; Department of Paediatrics and Child Health, School of Medicine, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, 255, Tanzania., Badhal S; Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India., Brobby NW; Department of Child Health, Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana., Chellani HK; Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India. chellaniharish@gmail.com., Chopra N; Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India., Debata PK; Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India., Dube Q; Queen Elizabeth Central Hospital, Blantyre, Malawi., Dua T; Department of Mental Health and Substance Use, World Health Organization, Geneva, Switzerland., Gadama L; Department of Obstetrics and Gynaecology, Kamuzu University of Health Sciences, Blantyre, Malawi., Gera R; Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India., Hammond CK; Department of Child Health, Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana., Jain S; Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India., Kantumbiza F; Department of Paediatrics and Child Health, Kamuzu University of Health Sciences, Blantyre, Malawi., Kawaza K; Department of Paediatrics and Child Health, Kamuzu University of Health Sciences, Blantyre, Malawi., Kija EN; Department of Paediatrics and Child Health, School of Medicine, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, 255, Tanzania., Lal P; Atal Bihari Vajpayee Institute of Medical Sciences &, Dr Ram Manohar Lohia Hospital, New Delhi, 110001, India., Mallewa M; Department of Paediatrics and Child Health, Kamuzu University of Health Sciences, Blantyre, Malawi., Manu MK; Komfo Anokye Teaching Hospital, P.O. Box 1934, Adum, Kumasi, Ghana., Mehta A; Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India., Mhango T; Department of Paediatrics and Child Health, Kamuzu University of Health Sciences, Blantyre, Malawi., Naburi HE; Department of Paediatrics and Child Health, School of Medicine, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, 255, Tanzania., Newton S; School of Public Health, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana., Nyanor I; Research and Development, Komfo Anokye Teaching Hospital, P.O. Box 1934, Adum, Kumasi, Ghana., Nyako PA; Department of Psychiatry, Child And Adolescent Mental Health, Komfo Anokye Teaching Hospital, P.O. Box 1934, Adum, Kumasi, Ghana., Oke OJ; Department of Paediatrics and Child Health, Obafemi Awolowo University, Ile-Ife, 220005, Nigeria., Patel A; Department of Mental Health and Substance Use, World Health Organization, Geneva, Switzerland.; Division of Epilepsy & Clinical Neurophysiology, Boston Children's Hospital, Harvard Medical School, Boston, USA., Phlange-Rhule G; Clinical Development Services Agency (CDSA), Translational Health Science and Technology Institute (THSTI), NCR Biotech Science Cluster, PO Box #04, Faridabad, 121001, India., Sehgal R; Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029, India., Singhal R; Translational Health Science and Technology Institute (THSTI), NCR Biotech Science Cluster, PO Box #04, 121001, Faridabad, India., Wadhwa N; Faridabad-Gurgaon Expressway, Translational Health Science and Technology Institute, NCR Biotech Science Cluster, 3Rd MilestonePost Box #04, Faridabad, Haryana, 121001, India. nitya.wadhwa@thsti.res.in., Yiadom AB; Department of Child Health, Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana. |
| المصدر: | Trials [Trials] 2023 Apr 10; Vol. 24 (1), pp. 265. Date of Electronic Publication: 2023 Apr 10. |
| نوع المنشور: | Clinical Trial Protocol; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [London] : BioMed Central, 2006- |
| مواضيع طبية MeSH: | Kangaroo-Mother Care Method*/methods , Premature Birth*, Infant, Newborn ; Humans ; Female ; Child ; Birth Weight ; Follow-Up Studies ; Prospective Studies ; Infant Mortality ; Weight Gain ; Randomized Controlled Trials as Topic |
| مستخلص: | 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. (© 2023. The Author(s).) |
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| معلومات مُعتمدة: | 001 International WHO_ World Health Organization |
| فهرسة مساهمة: | Keywords: Immediate Kangaroo Mother Care (iKMC); Low- and middle-income countries; Low-birth-weight babies; Neurodevelopment |
| تواريخ الأحداث: | Date Created: 20230410 Date Completed: 20230412 Latest Revision: 20230903 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC10088121 |
| DOI: | 10.1186/s13063-023-07192-5 |
| PMID: | 37038239 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 1745-6215 |
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| DOI: | 10.1186/s13063-023-07192-5 |