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 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.

Effects of Maternal Stress on Breast Milk Production and the Microbiota of Very Premature Infants

“…Parental stress, if improperly managed, can lead to states of anxiety and depression in mothers, with significant negative impacts at both the personal and family level. High levels of parental stress following the birth of a very premature child can result in suboptimal bonding between mother and child poses a risk factor for poor behavioral and social development in childhood [ 3 , 7 , 8 , 9 ]. In our study population, the total stress in mothers of preterm infants decreased between 3 and 7 days post-delivery, subsequently increasing slightly at 15 days, possibly coinciding with the appearance of prematurity-associated complications in the newborn.…”

“…Furthermore, MOM has large amounts of circulating microRNAs, some of which are of great relevance in the immunoregulation of a newborn’s immune system. Health teams working in neonatal intensive care units (NICUs) should provide support to the mothers of premature newborns to facilitate breastfeeding establishment and maintenance, her presence for the newborn, and establish the kangaroo method as early as possible, which favors a reduction in maternal stress and facilitates the production of breast milk [ 7 , 8 , 9 , 10 , 11 ].…”

The beneficial effect of early and prolonged kangaroo mother care on long‐term neuro‐developmental outcomes in low birth neonates – A cohort study

“…The ongoing follow-up of the infants in the immediate KMC trial 26 will provide conclusive evidence of the effect of immediate KMC on neurodevelopment and could also provide a dose-response effect.…”

“…Despite these limitations, this is the first study to show that early initiation within 72 h of life and prolonged duration of KMC >8 h per day have a positive influence on neurodevelopment at 1 year of age. The ongoing follow‐up of the infants in the immediate KMC trial 26 will provide conclusive evidence of the effect of immediate KMC on neurodevelopment and could also provide a dose–response effect.…”