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
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
Affiliations
E. A. Adejuyigbe
Department of Paediatrics and Child Health, Obafemi Awolowo University
I. Agyeman
Komfo Anokye Teaching Hospital
P. Anand
Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital
H. C. Anyabolu
Department of Paediatrics and Child Health, Obafemi Awolowo University
S. Arya
Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital
E. N. Assenga
Department of Paediatrics and Child Health, School of Medicine, Muhimbili University of Health and Allied Sciences
S. Badhal
Vardhman Mahavir Medical College and Safdarjung Hospital
N. W. Brobby
Department of Child Health, Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and Technology
H. K. Chellani
Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital
N. Chopra
Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital
P. K. Debata
Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital
Q. Dube
Queen Elizabeth Central Hospital
T. Dua
Department of Mental Health and Substance Use, World Health Organization
L. Gadama
Department of Obstetrics and Gynaecology, Kamuzu University of Health Sciences
R. Gera
Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital
C. K. Hammond
Department of Child Health, Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and Technology
S. Jain
Vardhman Mahavir Medical College and Safdarjung Hospital
F. Kantumbiza
Department of Paediatrics and Child Health, Kamuzu University of Health Sciences
K. Kawaza
Department of Paediatrics and Child Health, Kamuzu University of Health Sciences
E. N. Kija
Department of Paediatrics and Child Health, School of Medicine, Muhimbili University of Health and Allied Sciences
P. Lal
Atal Bihari Vajpayee Institute of Medical Sciences &, Dr Ram Manohar Lohia Hospital
M. Mallewa
Department of Paediatrics and Child Health, Kamuzu University of Health Sciences
M. K. Manu
Komfo Anokye Teaching Hospital
A. Mehta
Vardhman Mahavir Medical College and Safdarjung Hospital
T. Mhango
Department of Paediatrics and Child Health, Kamuzu University of Health Sciences
H. E. Naburi
Department of Paediatrics and Child Health, School of Medicine, Muhimbili University of Health and Allied Sciences
S. Newton
School of Public Health, Kwame Nkrumah University of Science and Technology
I. Nyanor
Research and Development, Komfo Anokye Teaching Hospital
P. A. Nyako
Department of Psychiatry, Child And Adolescent Mental Health, Komfo Anokye Teaching Hospital
O. J. Oke
Department of Paediatrics and Child Health, Obafemi Awolowo University
A. Patel
Department of Mental Health and Substance Use, World Health Organization
G. Phlange-Rhule
Clinical Development Services Agency (CDSA), Translational Health Science and Technology Institute (THSTI), NCR Biotech Science Cluster
R. Sehgal
Department of Pediatrics, Vardhman Mahavir Medical College and Safdarjung Hospital
R. Singhal
Translational Health Science and Technology Institute (THSTI), NCR Biotech Science Cluster
N. Wadhwa
Faridabad-Gurgaon Expressway, Translational Health Science and Technology Institute, NCR Biotech Science Cluster
A. B. Yiadom
Department of Child Health, Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and Technology
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.