跳至主要内容
临床试验/CTRI/2018/04/013068
CTRI/2018/04/013068已完成4 期

Study regarding the Quality of Life in children with Severe Acute Malnutrition.

UNICEF1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2015年1月7日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
UNICEF
入组人数
105
试验地点
1
主要终点
To assess the functioning of SAM children with respect to physical, emotional, social

研究概览

简要总结

Children between 5 to 12 years of age admitted in thePediatrics ward and also those

children coming to the outpatient department, were diagnosedas severe thinness after

an anthropometric screening. Every alternate child diagnosedas severe thinness was

included in the study group after ruling out other chronicillnesses (except tuberculosis).

Age and sex matched healthy siblings of these children andother children hospitalized

for various illnesses, with normal nutritional status wereincluded as controls. A written

informed consent from the parents (Annexure III) and ascentof the patient was

obtained.

A detailed history including demographic information such asage, gender , socio

economic status(SES) and community was recorded in apredesigned case record form

(Annexure IV).A detailed dietary history, birth history,immunization history and

developmental history were also obtained.

The socioeconomic status was categorized usingKuppuswamy  Scale .

A detailed general physical examination ( includingassociated clinical findings like anemia,

clubbing, pedal edema) and systemic examination was donewith special emphasis on

anthropometric measurements and nutritional status which wasderived based on weight and

height. Weight was determined using electronic weighingscale and height was determined by

stadiometer.Body Mass Index was calculated using theformula( weight in kg)/( height in

metre)2

Children with BMI for age less than or equal to threestandard deviations WHO 2007 reference

value were designated to have Severe Thinness . Thosechildren falling between two and

three standard deviations below the median were designatedto have Thinness. The height for

age and weight for age less than or equal to three standarddeviations were designated as

severely stunted and severe underweight respectively. Thosefalling between two and three

standard deviations below the median were designated asstunted and moderately under

weight respectively

Baseline investigations including complete hemogram, liverfunction test ( SGOT/SGPT ,

serum albumin) , renal function test ( blood urea nitrogen /serum creatinine) were done.

Special investigations : chest xray,sputum for AFB, mantoux,USG abdomen , CT scan

chest/abdomen were done as indicated. These investigationswere reviewed and documented.

The quality of life assessment was performed using thePediatric Quality of Life Inventory

(PedsQL) 4.0 Generic Core Scale. A user agreement was signedwith the MAPI research

Institute, Lyon, France, prior to the use of thequestionnaire. The Peds QoL4.0 Generic Core

Scale includes parallel child self-reports and parentproxy-reports (Annexure VI). We used this

questionnaire in 3 languages, UK English, Hindi and Marathi.Two separate questionnaires

were administered for children aged 5 to 7 years and 8 to 12years. Children between 7 to 8

years were given the questionnaire used by children in theage group 8 to 12 years. These

were completed independently by children and their parents.

Peds QoL items ask how much of a problem a particular issuehas been for the patient during

certain period. Item responses are measured on 5 pointrating scale ranging from 0 (almost

always problem) to 100 (never a problem). These 23 itemsconsist of 8 items on physical

functioning, 5 on emotional, 5 on social, and 5 on school,yielding a total score ranging from 0

to 100 with higher score indicating higher quality of life(83)(54). Additionally, the Peds QoL 4.0

questionnaire contains a Psychosocial Health Summary scorewhich represents the sum of

items over the number of items answered in the emotional,social and school functioning

scales.

The scores for each dimension are calculated as follows: themean score is represented by the

sum of the items over the number of items answered; missingvalues are replaced by the

mean score of the remaining items; if more than 50% of theitems in a given scale are missing,

the scale scores are not computed. Raw scores aretransformed into standardized scores on a

scale from 0 to 100 with higher scores representing higherfunctioning levels.

The reliability, internal consistency and validity of thePedsQL questionnaire have been

assessed in pediatric populations with acute and chronichealth conditions, besides in

physically healthy pediatric populations.

A study of physical, social, emotional and scholastic scoreswas performed on children

between 5 and 12 years with severe thinness and it wascompared against the same

for normal children in the same age group. For children whowere hospitalized, they

were interviewed after recovering from acute illness andbefore discharge from hospital.

Also the socio-economic status of the child and his parents(parent’s education,

occupation and income) and the basic details(age/gender/community/presenting

complaints etc) were collected and compared. The sample sizewas estimated as 60

subjects and 45 controls (Total = 105). Socio-demographicvariables were recorded

and the HRQOL was assessed with PedsQL 4.0.

研究设计

研究类型
Observational

入排标准

年龄范围
5.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • •children with severe thinness in the age group 5-12 years 2) Age, sex, socio-economic and culturally matched healthy children as controls.

排除标准

  • •Children with severe thinness who were chronically ill or immunocompromised.
  • •Mentally unstable children who were severely thin.
  • •Children with oncological and neurological illness.

结局指标

主要结局

To assess the functioning of SAM children with respect to physical, emotional, social

时间窗: Day 1

and psychological wellbeing with the help of PedsQL questionnaire.

时间窗: Day 1

次要结局

  • To assess the impact of social and demographic factors on the quality of life in children with severe thinness.

研究者

发起方
UNICEF
申办方类型
Other [Non-governmental organization]

研究点 (1)

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