NEURODEVELOPMENTAL OUTCOME OF HIGH RISK NEONATES
- Conditions
- Attention-deficit hyperactivity disorder, predominantly inattentive type,
- Registration Number
- CTRI/2023/08/055981
- Lead Sponsor
- Not applicable
- Brief Summary
Every new born baby has to go through a complex process of growth and
development at various levels to ultimately emerge as a normal adult. Any
deviation in these stages of development will lead to developmental disability.
Such disability may express in various forms, which include mental retardation,
cerebral palsy, autism, attention deficit disorders, visual and hearing problems,
speech and language disorders, learning disabilities and many more. These
problems increase as birth weight decreases. Impaired neurodevelopmental
outcome is a major long-term complication of surviving premature infants,
especially extremely premature infants who are born at or below 32 weeks
gestation.1-2 Sick neonates, particularly preterm babies, very low birth weight
(VLBW) and extremely low birth weight (ELBW) babies (birth weights less
than 1500 and 1000 g respectively) with perinatalhypoxia and
hypoxic-ischaemic encephalopathy, sepsis, severe jaundice, etc. are most
vulnerable to poor neuro-developmental outcome.3These are classified as high
risk infants.
Insult to the developing brain may lead to gross and fine structural
changes resulting in smaller brain size, reduced white and grey matter,
ventriculomegaly, decreased callosal projections and altered fibre tract
organization, which eventually affects neural function.4 Hence, a close
neuro-developmental follow-up of these high-risk newborns is essential for
early detection of any brain damage, to prevent or restrict a poor
neuro-developmental outcome through early intervention.
Intrauterine and neonatal insults substantially affect the global burden of
disease, measured in disability-adjusted life-years, because they contribute to
both premature mortality and long-term disability.5 However, little is known
about the severity and distribution of long-term impairments after intrauterine or
neonatal insults. As a result, sequelae from intrauterine and neonatal insults
have not been adequately captured in estimates of the global burden of
disease.6,7
In India, unfortunately, there is not enough awareness about the
abovementioned facts and that neurodevelopment assessment has long been
considered the domain of pediatric neurologist, and general paediatricians often
fail to recognize the delay that had begun to set in the neonatal intensive care
unit (NICU) graduate that had come to him for various medical problems.
Though perinatal and newborn care is improving in rural India, a section of the
rural population is still deprived of all the available facilities, due to
socio-economic, cultural and topographical reasons. There is very scanty data
from this part of the globe, regarding neuro-devel-opmental outcome of high
risk newborns and the magnitude of the problem of evolving developmental
challenges, hence we remain oblivious of the gravity of the situation. This
opportunity is big one to miss because, it was at this point, if early intervention
done to modify social and psychosocial environment of the infant would have
made a large difference to his eventual neurodevelopment outcome.​
Recognition of precipitating factors and adequate preventive measures,
detection of early markers of developmental delay and early intervention
measures can go a long way in preventing childhood disability.8 This calls in for
a neuro-developmental follow-up of high risk babies by a specialized team,
using proper scientific methodology.9
With this background, we will venture to follow up high risk babies discharged
from the Tertiary Newborn Care unit at wardha, a district of Maharashtra, India
to study the prevalence of delayed development in high risk babies and identify
their various aetiological factors and associations. Simultaneous provision of
early intervention will also initiated as a preventive and therapeutic measure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 80
- o High risk babies discharged from Neonatal intensive care unit.
- o Patients of babies giving consent for the Study.
- o Babies born with gross Congenital Malformations and syndromes o Drop outs and failure to follow up from the study.[if followed less than three visits out of four visits] o Parents not giving consent for the study.
- o Babies with major congenital heart diseases.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To study prevalence of neurodevelopmental delay of high risk babies. 2 years 2.To study neurodevelopmental outcome in relation to gestational age at birth. 2 years
- Secondary Outcome Measures
Name Time Method 3.To study neurodevelopmental outcome in relation to birth weight.
Trial Locations
- Locations (1)
Datta meghe institute of higher education and research
🇮🇳Wardha, MAHARASHTRA, India
Datta meghe institute of higher education and research🇮🇳Wardha, MAHARASHTRA, IndiaDr Anuja HandargulePrincipal investigator9619113984anujahandargule@gmail.com