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CTRI Number  CTRI/2024/10/076044 [Registered on: 29/10/2024] Trial Registered Prospectively
Last Modified On: 26/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Beneficial effect of oral application of colostrum or mothers own milk in preterm babies. 
Scientific Title of Study   To evaluate the beneficial effect of oral application of colostrum or mothers own milk in preterm baby A randomised controlled trial  
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 Mahaveer Singh Lakra 
Designation  Assistant professor 
Affiliation  Datta Meghe Institute of Higher Education and Research,Sawangi Meghe. 
Address  Assistant professor, Department of paediatrics, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha.

Wardha
MAHARASHTRA
442001
India 
Phone  09992693363  
Fax    
Email  lakra.mahaveer@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amar Taksande 
Designation  Professor and HOD 
Affiliation  Datta Meghe Institute of Higher Education and Research,Sawangi Meghe. 
Address  Jawaharlal Nehru Medical College Sawangi Meghe Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  09822369233  
Fax    
Email  amar.taksande@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amar Taksande 
Designation  Professor and HOD 
Affiliation  Datta Meghe Institute of Higher Education and Research,Sawangi Meghe. 
Address  Jawaharlal Nehru Medical College Sawangi Meghe Wardha


MAHARASHTRA
442001
India 
Phone  09822369233  
Fax    
Email  amar.taksande@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research,Sawangi Meghe, Wardha, Maharashtra. 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research,  
Address  Sawangi Meghe, Wardha,Maharashtra. India 
Type of Sponsor  Private 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 Mahaveer Lakra  Acharya Vinoba bhave Rural Hospital  Room no. 4, Near neonatology OPD area
Wardha
MAHARASHTRA 
9992693363

lakra.mahaveer@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (DU)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E649||Sequelae of unspecified nutritional deficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mothers own milk/ colostrum  Route- Oropharyngeal Dose- 0.2 ml ofMothers own milk/ colostrum Duration: Till 32 weeks Frequency: Every 2 hours for 48 hours, then every 3 hours  
Comparator Agent  Normal saline  Route- Oropharyngeal Dose- 0.2 ml of normal saline Duration: Till 32 weeks Frequency: Every 2 hours for 48 hours, then every 3 hours 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  45.00 Day(s)
Gender  Both 
Details  Sick babies with less than 32 weeks of gestation requiring CPAP or ventilation who is not receiving feed directly.
2) Mother plans to pump and provide milk for babies admitted in NICU.
3) NICU admissions less than 24 hrs. of life and inborn babies
4) Ability to begins protocol within 96 hours of life.
 
 
ExclusionCriteria 
Details  Babies having
1. birth asphyxia (cord ph/arterial ph less than7)
2. Presence of significant congenital anomalies
4. Parents not giving consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The serum IgA level values in two groups
The incidence of Ventilatory associated pneumonia 
Oral application of milk - 24 hours
Serum IgA blood values at 7 days of life
Septic Screening at 7-10 days

Discharge or death at the time of discharge 4-6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Total days of hospital stay
The incidence of septicaemia and necrotising enterocolitis
Outcome in form of death or discharge 
Subject enrolment at 24 hours of life
Application of milk at 48 hours of life
Estimation of serum IgA level at 7 and 14 days of life
Recording of occurrence of septicaemia and necrotising enterocolitis at any of time
Collection of Mortality data throughout and at the time of discharge  
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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)   10/11/2024 
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="11"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Background: Premature babies are at higher risk for getting infection and necrotizing enterocolitis leading to significant morbidity and mortality. Mothers own milk contain protective enzymes and immunoglobulins which provide antimicrobial, anti-inflammatory and can lower down the rates of infection and necrotizing enterocolitis. Oropharyngeal administration of own mother’s milk may raise serum IgA level which improve the overall outcome of preterm babies.  

Aim and Objectives: To estimate the salivary IgA level in babies and to corelate the incidence of sepsis and necrotizing enterocolitis with oral application of colostrum and mothers’ own milk (MOM).

Design of study: Randomized control trial. Setting: NICU, JNMC Sawangi Meghe. Duration: 1 year

Methodology: All inborn babies less than 32 weeks of gestation requiring CPAP and Ventilation and not receiving feed will be included in study. Babies will be allocated in two groups by randomized selection. Interventional group will be applied colostrum to oral mucosa and will receive 0.2 ml of own mother’s own milk via oropharyngeal administration. Control group babies receive a placebo (0.2 ml sterile water) following the same protocol. The serum IgA level will be estimated after 7 days in all babies. The incidence of septicemia, NEC and total stay will be noted down during course of hospital stay.

Data collection and analysis: Demographic information will be collected and detailed perinatal history will be noted. The septicemia parameters, abdominal girth, feed intolerance and x ray findings will be noted. The serum IgA levels will be calculated and compared in two groups. The data will be analysed by the STATA 10 software. The chi- square and Fischer’s exact two tail test will be used to study the frequency, odd ratio and p value < 0.05 will be considered significant.

 

Key Words: Colostrum, Mothers own milk, Septicemia, Immunoglobulin, Necrotizing enterocolitis,

 
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