| 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
|
|
|
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
|
|
|
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. |