| Autor: |
EA Adejuyigbe, I Agyeman, P Anand, HC Anyabolu, S Arya, EN Assenga, S Badhal, NW Brobby, HK Chellani, N Chopra, PK Debata, Q Dube, T Dua, L Gadama, R Gera, CK Hammond, S Jain, F Kantumbiza, K Kawaza, EN Kija, P Lal, M Mallewa, MK Manu, A Mehta, T Mhango, HE Naburi, S Newton, I Nyanor, PA Nyarko, OJ Oke, A Patel, G Phlange-Rhule, R Sehgal, R Singhal, N Wadhwa, AB Yiadom |
| Rok vydání: |
2022 |
| Popis: |
Background:Preterm birth or low birth weight is the single largest cause of death in newborns, but the 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 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 morbidity, or the immediate KMC will 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 two years of life, and assessing their growth and neurodevelopment. Methods:This prospective cohort study will enroll surviving neonates from the main immediate KMC trial. The main trial as well as this follow-up study are being conducted in five low- and middle-income income countries in South Asia and sub-Saharan Africa. The sample size for comparison of risk of neurodevelopmental impairment is a total of about 2200 neonates. The primary outcomes will include rates of cerebral palsy, hearing impairment, vision impairment, mental and motor development, and epilepsy and will be assessed by the age of three years. The analysis will be by intention to treat.DiscussionImmediate 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, therefore, help in evaluating the overall impact of KMC by investigating the long-term effect on neurodevelopmental impairment in the survivors.Trial registrationClinical Trials Registry-India: CTRI/2019/11/021899 on 06 November 2019 |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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