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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E43||Unspecified severe protein-caloriemalnutrition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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 
Details  no 
 
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.


 
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