CTRI Number |
CTRI/2019/06/019650 [Registered on: 12/06/2019] Trial Registered Prospectively |
Last Modified On: |
13/02/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Follow Up Study |
Study Design |
Non-randomized, Multiple Arm Trial |
Public Title of Study
|
Severe malnutrition under 6 months |
Scientific Title of Study
|
To study the prevalence of suboptimal infant feeding practices in children aged 1 to 6 months admitted with severe malnutrition.
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Ramesh Kumar |
Designation |
PG |
Affiliation |
Dr S N Medical college, Jodhpur. |
Address |
Nutrition Rehabilitation Center
Department of Paediatrics MDM Hospital Jodhpur
Jodhpur RAJASTHAN 342003 India |
Phone |
9600791920 |
Fax |
|
Email |
ramesh99kc@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Anurag singh |
Designation |
Head of Department, |
Affiliation |
Dr S N Medical college jodhpur. |
Address |
Department Of Paediatrics
MDM Hospital Jodhpur
Jodhpur RAJASTHAN 342005 India |
Phone |
9414133692 |
Fax |
|
Email |
singhjodhpur@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Anurag singh |
Designation |
Head of Department, |
Affiliation |
Dr S N Medical college jodhpur. |
Address |
Department Of Paediatrics
MDM Hospital Jodhpur
Jodhpur RAJASTHAN 342005 India |
Phone |
9414133692 |
Fax |
|
Email |
singhjodhpur@gmail.com |
|
Source of Monetary or Material Support
|
Dr S N Medical college jodhpur |
|
Primary Sponsor
|
Name |
Regional Center of Excellence Dr S N Medical college jodhpur |
Address |
Sasthri Nagar Jodhpur ,
332003 |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Ramesh Kumar |
Regional Center Of Excellence (tertiary care centre ) |
Deptartment of Paediatrics, Dr S N Medical college jodhpur Jodhpur RAJASTHAN |
9600791920
ramesh99kc@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institution Ethics Committee (IEC) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E43||Unspecified severe protein-caloriemalnutrition, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
1.00 Month(s) |
Age To |
6.00 Month(s) |
Gender |
Both |
Details |
all child admitted in tertiary care center with severe malnutrition 1 month to 6 month of age |
|
ExclusionCriteria |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To study the infant and young child feeding practices in children suffering with severe malnutrition in 1 to 6 months of age |
1month to six months |
|
Secondary Outcome
|
Outcome |
TimePoints |
To know the prevalence of sub optimal infant and young child feeding practices in children admitted with severe malnutrition in 1 to 6 moths of age |
1 month to 6 month |
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 1 |
Date of First Enrollment (India)
|
28/06/2019 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
none |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
India is facing a grave challenge of having very high rates of under nutrition in childhood and a high infant mortality rate. The study found a statistically significant difference in poor infant and young child feeding practices in the children admitted with severe malnutrition in the 1-6 months age study group as compared to children in the same age group admitted with illness other than severe malnutrition. We found 78% prevalence of suboptimal infant feeding practices in the study group. Exclusive breastfeeding was practiced only in 22% children in this group. We observed high prelacteal feed (36.08%), colostrum feeding (77.31%), low early initiation of breastfeeding (10.35%), bottle feeding (34%), dilated goat milk (35%) as top feed and water (58%). In study group the top feeds were initiated earlier (1-3months of age) compared to 4-6 months of age in control group. This lack of exclusive breastfeeding was a major contributory factor to development of malnutrition in this age group. Most common indication for hospitalization in study group was difficulty in breathing followed by poor weight gain. Factors other than feeding practices are also contributory in the 1-6 months age group and the most common co-morbidity associated in our study group were anemia (38), congenital heart disease (17), bronchopneumonia (9) and acute kidney injury (7). Multisystem affective conditions like cerebral palsy (4), Klinefelter syndrome (1), Down syndrome (1), congenital adrenal hyperplasia (1) also presented with severe malnutrition. 16 infants in study group were premature delivered. Our study has shown that giving prelacteal feed, delayed initiation of breastfeeding at birth, improper duration of each feed and early initiation of top feed contribute a major role in developing under nutrition in infant under 6 months of age. Lack of sustained support and motivation of mothers were major contributors for poor IYCF practices in the study group mothers. These could emanate from the statistically highly significant low KAP scores regarding breastfeeding practices of the primi and multiparous mothers in study and control group (P < 0.0003). Poor feeding practices were also documented in history of breastfeeding using a structured format wherein most of the multiparous mothers had low breast feeding history scores in the study group (P value 0.0003). In children who were admitted without malnutrition mothers scored better and the difference between breastfeeding history scores was statistically significant (P=0.039). The same thing was further cemented by direct observation of breastfeeding utilizing a structured breastfeeding observation form. Low scores were documented for maximum number of multiparous mothers in the study group (90.14%) (P=0.0002). Similar was the case with primiparous mothers in study group; who also had statistically significant lower scores on structured breastfeeding observation form (P=0.010). Use of bottle feeding was very high (34 %) in the 1-6 months old children admitted with severe malnutrition as compared to only 4 % in the non malnutrition group. Relactation by SST was successful in 16 mothers and it helped the children to recover from their severe malnutrition. |