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CTRI Number  CTRI/2025/11/097323 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 12/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To study complementary feeding practices in preterm infants 
Scientific Title of Study   Complementary feeding practices in preterm infants-A cross sectional study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priya Hulamani 
Designation  MD Paediatrics 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Paediatrics ,Jawaharlal Nehru Medical College,Nehru Nagar road Belagavi
Department of Paediatrics ,KAHERs Jawaharlal Nehru Medical College,Nehru Nagar road Belagavi
Belgaum
KARNATAKA
590010
India 
Phone  9108088358  
Fax    
Email  drpriyaahulamani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Roopa M Bellad 
Designation  Professor In Paediatrics 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Paediatrics ,KAHERs Jawaharlal Nehru Medical College,Nehru Nagar road Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9448113403  
Fax    
Email  belladroopa5@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr PRIYA HULAMANI 
Designation  MD Paediatrics 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Paediatrics ,KAHERs Jawaharlal Nehru Medical College,Nehru Nagar road Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9108088358  
Fax    
Email  drpriyaahulamani@gmail.co  
 
Source of Monetary or Material Support  
KLEs DR PRABHAKAR KORE HOSPITAL,Jawaharlal Nehru Medical college ,Nehru Nagar Belagavi 
 
Primary Sponsor  
Name  Dr Priya Hulamani 
Address  Department of Paediatrics ,KAHERs Jawaharlal Nehru Medical College,Nehru Nagar road Belagavi 
Type of Sponsor  Other [self] 
 
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 PRIYA HULAMANI  KLEs Dr.PRABHAKAR KORE HOSPITAL BELAGAVI  Department of Paediatrics,Jawaharlal Nehru Nagar,KLE Hopital Road Belgaum KARNATAKA
Belgaum
KARNATAKA 
9108088358

drpriyaahulamani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PRETERM INFANTS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  11.00 Month(s)
Age To  13.00 Month(s)
Gender  Both 
Details  1.Preterm Infants Of 11 to 13 Months (window period),born less than 37 weeks of gestatioal age and coming to Paediatric OPD and infants admitted in inpatient department.
2.Parents/guardians of preterm infants who are giving consent for study. 
 
ExclusionCriteria 
Details  1.Infants with congenital malformation affecting feeding e.g.-cleft palate and cleft palate and cleft lip,cerebral palsy,congenital heart disease.
2.Infants with known chronic systemic diseases(e.g.GERD,Chronic kidney disease,tracheoesophageal fistula)
3.Sick infants requiring admission or immediate care.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Using World Health Organization infant and young feeding indicators such as:
MINIMUM DIETARY DIVERSITY(MMD)
MINIMUM MEAL FREQUENCY(MMF)
MINIMUM ACCEPTABLE DIET(MAD)
Percentage of infants who meet the criteria for each indicator will be calculated and identify factors associated with appropriate complementary feeding practices,and its outcome on improved infants health,reduced risk of malnutrition and long term well being of infants. 
over a span of one year 
 
Secondary Outcome  
Outcome  TimePoints 
Growth outcome of infants at 11 to 13 months age is analysed using anthropometric measurements and association between complementary feeding and growth of infants.  over span of one year 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
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   N/A 
Date of First Enrollment (India)   25/11/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Complementary feeding is defined as the process of providing food when breast milk or milk formula alone are no longer adequate to meet nutritional requirements. WHO recommends starting complementary feeding at 6 months of age and continues till 23 months. Breast feeding has to be continued along with complementary feeding. (4).  In LMIC’S National guidelines recommends complementary feeding begin at 6 months (4,64,65). After the age of 6 months, complementary feeding gives additional source of protein, iron, zinc, vitamin A and other essential micronutrients, prevents malnutrition, helps in cognitive, motor and socio-emotional development. reduces the risk of non-communicable diseases like Obesity, Type 1 diabetes. (14)

 

According to the NFHS-5 data (2019–2021), in India, the percentage of children aged 6–8 months receiving solid or semi-solid food along with breastmilk is 52% in urban areas, 43.9% in rural areas, and 45.9% overall. Among breastfeeding children aged 6–23 months, only 11.8% received an adequate diet, while 12.7% of nonbreastfeeding children in the same age group received an adequate diet. Overall, only 11.3% of children aged 6– 23 months were reported to be receiving an adequate diet.

 

In Karnataka, as per the NFHS-5 (2019–2020) data, 11.0% of breastfeeding children aged 6–23 months were receiving an adequate diet. Among non-breastfeeding children, this figure was 19.5%, with a total of 12.8% of children in this age group receiving an adequate diet.

 

In Belgaum district, 35.6% of infants were introduced to complementary foods during their sixth month. Among mothers, 9.3% reported giving one complementary feed per day, 18% reported giving two feeds per day, while the remaining mothers reported giving complementary foods three or more times per day.(199)

 

Preterm birth is defined as the birth of a baby before 37 completed weeks of gestation. Globally, the prevalence of prematurity is approximately 10–12%, and according to NFHS-5 data, the prevalence in India is around 12%. Prematurity is one of the leading causes of mortality and morbidity during the first year of life and contributes significantly to under-five mortality(2). In preterm infants, the development of a normal feeding pattern can be disrupted by extrauterine influences, resulting in dysphagia or abnormal swallowing. This may include impaired sucking, swallowing, or airway protection, which compromises the efficacy, adequacy, and most importantly, the safety of oral feeding. Dysphagia in preterm infants may reflect underlying anatomical or neurological abnormalities or injuries, or may simply be due to functional immaturity influenced by external sensory inputs(16). While feeding problems are seen in about 1% of the general pediatric population, the prevalence is significantly higher among preterm infants and is directly proportional to the degree of prematurity.(15) Residual feeding problems in growing preterm infants present with a wide range of phenotypes, including feeding tube dependency(30), nonspecific feeding difficulties, oral and feeding aversions(9,31,32). delayed transition to solid foods, difficulty with specific food textures (e.g., solids), and subtle swallowing dysfunctions. These feeding issues, compounded by delayed and inadequate nutrition, can lead to impaired growth and development in preterm infants.


A position paper done by Italian neonatal,paediatric and paediatric gastroenterology joint societies summarised current evidence regarding complementary feeding in preterm infants. However in India Guidelines for Complementry feeding not appropriate for preterm infants and lack of evidence-based recommendations and Indicators for adequate complementary feeding for preterm infants.

 
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