Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05891210 |
| Other study ID # |
congenital heart |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2023 |
| Est. completion date |
December 1, 2024 |
Study information
| Verified date |
May 2023 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Congenital heart disease (CHD) defined as anatomic malformation of the heart and great
vessels which occurs during intrauterine development irrespective of the age of
presentation(1) It is classified into acyanotic and cyanotic depending upon whether the
patients clinically exhibit cyanosis(2) .
It is the most common human developmental anomaly with a reported prevalence of between 4 to
10 per 1000 live birth (3-6).
The variety and severity of clinical presentation depend on the cardiac structures involved
and their functional impact (7).
Previous studies have found that, although birth weight for gestational age is usually normal
in patients with congenital heart disease, young children often present with impaired growth
parameters (8,9) The underlying causes of this failure to thrive may be multifactorial
including innate growth potential, severity of cardiac underlying disease, increased energy
requirements ,decreased nutritional intake, malabsorption and poor utilization of absorbed
nutrients .these factor are particularly common and sever in low and middle income countries
(11) Several studies suggest that the failure to thrive is associated with poorer cognitive
development, learning disabilities, and long term behavioral problems more recently Corbett
et al (12) detected a significant association between the severity of growth deficiency and
IQ ,whereas Raynor and Rudolf (13) found that 55% of the infants who were failing to thrive
exhibited developmental delay .In addition , A study by Reif et al (14) reported that
children with a history of failure to thrive were found to have more learning difficulties
and evidenced developmental delay at follow up 5 years after the initial presentation(15).
Achieving survival is not the only target of clinicians for these patients, appropriate
growth, development and improved quality of life are also very important.
The management of children with congenital heart disease require multidisciplinary
approach,in which the nutritional aspect plays an important role ,an adequate caloric intake,
in fact this improve the out come of these patients.(7) This study will asses the nutritional
status for patients with congenital heart disease Who are admitted at assiut university
hospital children and adopting a protocol for nutritional support for them.
Description:
1. Full history taking including date of birth,gender,residence,and socioeconomic status.
According To Socioeconomic status we will ask about where the family live,family income
(high or middle or low income) Perinatal history as maternal age,gestational
diseases,medications use during pregnancy,irradiation exposure ,presence of antenatal
care.
Natal hisrory ;mode of delivery(vainal,cesarean) ,site of delivery (home,hospital) Post
natal history; required resuscitation or not,cyanosis,jaundice and incubator care needed
or not,birth weight will be categorized into appropriate ,small or large for gestational
age.
Feeding history; breast or formula feeding,age of weaning ,type of food for weaning,
supplementation of vitamin D.iron.
2. All patients will subject to general and systemic examination. Children included in our
study will fall under Complete general and systemic examination especially heart
disease.
3. Nutritional assessment and anthropometric measures will be followed up to these
patients; AThe weight ; will be taken on a scale that has been properly calibrated and
the value will be plotted on a standardized WHO growth chart .
B)The height ; this measurement for children more than 2years will be taken without shoes
using astadiometer and the value will be plotted on the WHO growth chart.
C)The length; this measurement in children 2 years and younger is more accurate ,the child
will position in supine on ameasuring board.
D)Head circumference; will be measured using a flexible tabe ,we will measure the maximum
diameter through the supraorbital ridge to the occiput and the value will be plotted on the
growth chart.
E)Mid arm circumference; this measured using a flexible nonstretch tape laid at the midpoint
between the acromion and olecranonprocesses on the shoulder blade and the ulna respectively.
F) BMI:
Measured by the person's weight divided by the square of height in meters for children aged
more than 2years and will be plotted at the WHO growth chart.
